66 results on '"Andrea Giusti"'
Search Results
2. Pathogenesis, Diagnosis and Management of Polymyalgia Rheumatica
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G. Girasole, Andrea Giusti, Christian Dejaco, Gerolamo Bianchi, and Dario Camellino
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musculoskeletal diseases ,medicine.medical_specialty ,Giant Cell Arteritis ,Diagnosis, Differential ,Polymyalgia rheumatica ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,immune system diseases ,Pathognomonic ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,skin and connective tissue diseases ,Adverse effect ,Glucocorticoids ,Aged ,Biological Products ,business.industry ,medicine.disease ,Dermatology ,Giant cell arteritis ,Polymyalgia Rheumatica ,Antirheumatic Agents ,Rheumatoid arthritis ,Methotrexate ,Geriatrics and Gerontology ,Vasculitis ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly characterised by pain and stiffness in the neck and pelvic girdle, and is the second most common inflammatory rheumatic condition in this age group, after rheumatoid arthritis. Polymyalgia rheumatica can occur independently or in association with giant cell arteritis, which is the most common form of primary vasculitis. The diagnosis of polymyalgia rheumatica is usually based on clinical presentation and increase of inflammatory markers. There are no pathognomonic findings that can confirm the diagnosis. However, different imaging techniques, especially ultrasonography, can assist in the identification of polymyalgia rheumatica. Glucocorticoids are the cornerstone of the treatment of polymyalgia rheumatica, but they might be associated with different adverse events. A subgroup of patients presents with a refractory disease course and, in these cases, adding methotrexate as a steroid-sparing agent could be useful. In this review, we summarise the latest findings regarding the pathogenesis, diagnosis and management of polymyalgia rheumatica and try to highlight the possible pitfalls, especially in elderly patients.
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- 2019
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3. Osteosarcopenia in Very Old Age Adults After Hip Fracture: A Real-World Therapeutic Standpoint
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Monica Pizzonia, Andrea Casabella, Marta Natali, Lorena Petrocchi, Luca Carmisciano, Alessio Nencioni, Luigi Molfetta, Chiara Giannotti, Gerolamo Bianchi, Andrea Giusti, Federico Santolini, and Fiammetta Monacelli
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Pediatrics ,medicine.medical_specialty ,Medicine (General) ,hip fractured very old age patients ,Osteoporosis ,030209 endocrinology & metabolism ,03 medical and health sciences ,0302 clinical medicine ,R5-920 ,medicine ,Vulnerable population ,030212 general & internal medicine ,Hip surgery ,osteosarcopenia ,Hip fracture ,business.industry ,denosumab ,longitudinal assessment ,muscle strength ,General Medicine ,Brief Research Report ,medicine.disease ,Denosumab ,Sarcopenia ,Cohort ,Muscle strength ,Medicine ,business ,medicine.drug - Abstract
Loss of bone and muscle mass and strength (i. e., osteosarcopenia) is a highly prevalent clinical condition in older adults, associated with an increased risk of fragility fractures and unfavorable clinical outcomes. Although sarcopenia is a potential risk factor for osteoporosis and subsequent fracture, and the management of this hazardous duet is the key to preventing osteoporotic fracture, evidence pertaining to the treatment of sarcopenia for the purpose of preventing fragile fractures remains insufficient. Given this scenario we aimed at prospectively compare the long-term effectiveness of bisphosphonates vs. denosumab, on bone and muscle, in a cohort of old age hip fractured patients by virtue of a timely osteo-metabolic and sarcopenic assessment. Ninety-eight patients consecutively enrolled at the IRCCS Hospital San martino, Genoa, Italy, received at baseline comprehensive geriatric assessment and Bone Densitometry (DXA) with the quantitative and quantitative bone analysis and evaluation of relative skeletal muscle index (RSMI) and longitudinally after 1 year form hip surgery. The results showed a slightly and non-significant osteo-metabolic improvement in the Alendronate group compared to the Denosumab group, and a positive trend of RSMI measurements in the Denosumab group. Although preliminary in nature, this is the first report to longitudinally analyze osteosarcopenia in a real-world cohort of very old age patients after hip fracture and moved a step forward in the understanding of the best osteo-metabolic therapy for long- term treatment, exploring as well the potential dual role of denousumab as antiresorptive and muscle strength specific drug for osteosarcopenia in this vulnerable population.
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- 2021
4. A novel effervescent formulation of oral weekly alendronate (70 mg) improves persistence compared to alendronate tablets in post-menopausal women with osteoporosis
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Andrea Giusti, Antonella Barone, Dennis M. Black, and Gerolamo Bianchi
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Aging ,medicine.medical_specialty ,Osteoporosis ,Post menopausal ,Persistence (computer science) ,03 medical and health sciences ,0302 clinical medicine ,Bone Density ,Internal medicine ,Statistical significance ,medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,Osteoporosis, Postmenopausal ,Alendronate ,Bone Density Conservation Agents ,business.industry ,Odds ratio ,medicine.disease ,Discontinuation ,Postmenopause ,Tolerability ,Female ,Geriatrics and Gerontology ,business ,030217 neurology & neurosurgery ,Tablets - Abstract
A novel effervescent buffered solution of 70 mg alendronate (ALN-EX) was developed to improve upper gastrointestinal (GI) tolerability over alendronate tablets (ALN-T). Whether a better GI tolerability can improve persistence remains to be determined. This study evaluated persistence and reasons for discontinuation in patients treated with ALN-EX compared to a historical cohort on ALN-T. Post-menopausal women (PMW) from a standardized clinical database with BMD T-score
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- 2020
5. Bisphosphonates for Postmenopausal Osteoporosis
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Andrea Giusti and Socrates E. Papapoulos
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0301 basic medicine ,Bone mineral ,medicine.medical_specialty ,Postmenopausal women ,business.industry ,Osteoporosis ,030209 endocrinology & metabolism ,Bone fragility ,Postmenopausal osteoporosis ,medicine.disease ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Internal medicine ,medicine ,business - Published
- 2018
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6. Orthogeriatric co-management – managing frailty as well as fragility
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Paolo Pignedoli, David Marsh, Chiara Bendini, Andrea Giusti, and Giulio Pioli
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Male ,Weakness ,medicine.medical_specialty ,Activities of daily living ,Health Services for the Aged ,Frail Elderly ,Osteoporosis ,030209 endocrinology & metabolism ,Comorbidity ,Audit ,03 medical and health sciences ,0302 clinical medicine ,Fragility ,Multidisciplinary approach ,Activities of Daily Living ,Secondary Prevention ,medicine ,Humans ,030212 general & internal medicine ,Policy Making ,Intensive care medicine ,Aged ,General Environmental Science ,Aged, 80 and over ,Patient Care Team ,Hip fracture ,Delivery of Health Care, Integrated ,Hip Fractures ,business.industry ,Risk factor (computing) ,medicine.disease ,Health Care Surveys ,General Earth and Planetary Sciences ,Female ,Health Services Research ,medicine.symptom ,business ,Delivery of Health Care ,Osteoporotic Fractures - Abstract
A high proportion of patients with fragility fracture, mainly hip fracture, have a variable degree of comorbidity and show some degree of dependence in basic or more complex activities of daily living. Evaluating these patents following the geriatric concept of frailty, about one third of hip fracture patients may be categorised as frail with high risk of poor outcomes and prolonged length of stay, one third as not frail, and about one third with an intermediate condition. Due to the high vulnerability, combined with the hip fracture event and surgical repair procedures, a multidisciplinary approach that includes geriatric competencies becomes essential to improve short and long-term outcomes after hip fracture. A key element of an effective process of care is a true co-managed approach that applies quality standards and provides a fast-track pathway of care, minimises the time the patient spends in bed, and reduces postoperative complications by means of standardised procedures. The occurrence of a fragility fracture is the strongest risk factor for a subsequent fracture. Moreover, frail subjects have a further risk of fracture due to high risk of falls - related to loss of muscle mass, multiple illnesses, impaired balance and weakness. Thus, effective secondary prevention strategies are essential to reduce morbidity and mortality after hip fracture, and they are currently a standard task of orthogeriatric care. Fracture liaison services (FLS) are probably the most efficient way of addressing secondary prevention including the assessment of both bone health and falls risk. Therefore, the optimal management of frail patients with fragility fracture includes both orthogeriatric care and FLS, which are complementary to each other. Orthogeriatric collaboration is also powerful in influencing healthcare policy. British experience as well as that in Ireland, Australia and New Zealand, have shown that when two widely disparate specialisms say the same thing, they may achieve a fundamental shift in attitudes and behaviour of both managers and clinicians. Furthermore, a continuous real-time audit, at national level, is a powerful driver for change and better standards of care.
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- 2018
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7. Surgical delay is a risk factor of delirium in hip fracture patients with mild–moderate cognitive impairment
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Paolo Pignedoli, Giulio Pioli, Michele Cappa, Maria Alice Ferri, Eleonora Bergonzini, Ettore Sabetta, Chiara Bendini, Andrea Giusti, and Enrico Iotti
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Male ,Aging ,Pediatrics ,medicine.medical_specialty ,Activities of daily living ,Osteoporosis ,Time-to-Treatment ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Activities of Daily Living ,medicine ,Humans ,Dementia ,Cognitive Dysfunction ,Prospective Studies ,030212 general & internal medicine ,Risk factor ,Geriatric Assessment ,Aged ,Retrospective Studies ,Aged, 80 and over ,Hip fracture ,Hip Fractures ,business.industry ,Delirium ,Cognition ,medicine.disease ,Comorbidity ,Case-Control Studies ,Multivariate Analysis ,Female ,Geriatrics and Gerontology ,medicine.symptom ,Cognition Disorders ,business ,030217 neurology & neurosurgery - Abstract
To investigate the relationship between onset of delirium and time to surgery in hip fracture (HF) patients with a different degree of cognitive impairment. Retrospective analysis of a prospective database of 939 older adults, aged ≥ 75 years admitted with a fragility HF. Subjects underwent a Comprehensive Geriatric Assessment on admission, evaluating health status, prefracture functional status in basic and instrumental activities of daily living, and walking ability. According to the Short Portable Mental Status Questionnaire score, patients were stratified into three categories: cognitively healthy (0–2 errors), mildly to moderately impaired (3–7 errors) and severely impaired (8–10 errors). Time to surgery (from admission) was expressed as days. The occurrence of delirium was ascertained daily by Confusion Assessment Method. Two hundred ninety-two (31.1%) patients experienced delirium during in-hospital stay. They were older, with a higher degree of comorbidity and functional impairment compared to patients without delirium. In multivariate analysis, surgical delay resulted a significant independent risk factor for delirium (HR 1.11, 95% CI 1.01–1.24), along with age, prefracture functional disability and cognitive impairment. When the analysis was performed accounting for the cognitive categories, surgical delay demonstrated to increase the risk of delirium only in the subcategory of mildly to moderately impaired patients, while no significant effect was demonstrated in patients cognitively healthy or severely impaired. The study supports the concept that older adults with HF should undergo surgery quickly. Patients with mild-to-moderate cognitive impairment should be primarily considered as the best target for interventions aiming to reduce time to surgery.
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- 2018
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8. Management of the aging beta-thalassemia transfusion-dependent population - The Italian experience
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Valeria Pinto, Andrea Giusti, Rodolfo Russo, Maurizio Poggi, and Gian Luca Forni
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medicine.medical_specialty ,Anemia ,Thalassemia ,Population ,Iron Chelating Agents ,03 medical and health sciences ,0302 clinical medicine ,hemic and lymphatic diseases ,medicine ,Humans ,Blood Transfusion ,education ,Intensive care medicine ,education.field_of_study ,business.industry ,beta-Thalassemia ,Beta thalassemia ,Disease Management ,Hematology ,medicine.disease ,Transplantation ,Hemoglobinopathy ,Oncology ,Italy ,030220 oncology & carcinogenesis ,Life expectancy ,Transfusion therapy ,business ,030215 immunology - Abstract
Thalassemia is among the most common monogenic diseases worldwide. Stem cell transplantation can be curative but is reserved for young patients, as probably gene therapy will be in the future. Adult thalassemia patients are treated with transfusion therapy and iron chelation, and improvements in the safety of transfusion protocols, use of iron chelation, monitoring of iron overload, and management of comorbidities have substantially prolonged survival, increasing the proportion of adult patients in the thalassemic population. However, older patients are more likely to develop multiple disease-related morbidities, including osteoporosis, endocrine disorders, liver disease, renal dysfunction, and cancer. Thus, the main objective of this article is to describe new challenges posed by the increasing life expectancy of patients with thalassemia, focusing on data from Italy where there is a well-documented history of thalassemia management. It is hoped that the mortality and morbidity benefits already seen in patients with thalassemia will continue to improve with ongoing advances in the quality of treatment.
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- 2019
9. Osteocalcin (bone GLA protein) levels, vascular calcifications, vertebral fractures and mortality in hemodialysis patients with diabetes mellitus
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Sandro Giannini, Andrea Aghi, Maria Fusaro, Stefania Sella, Maria Antonietta Rizzo, Luca Di Lullo, Maura Ravera, Antonio Piccoli, Annalisa Pitino, Fabrizio Fabris, Davide Gatti, Maurizio Gallieni, Thomas L. Nickolas, Mario Plebani, Maurizio Rossini, Giuliano Brunori, Giorgio Iervasi, Graziella D'Arrigo, Maria Cristina Mereu, Andrea Giusti, Antonio Bellasi, and Giovanni Tripepi
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Male ,Nephrology ,medicine.medical_specialty ,Vitamin K ,Bone disease ,medicine.medical_treatment ,Osteocalcin ,030232 urology & nephrology ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Gastroenterology ,Diabetes Complications ,03 medical and health sciences ,0302 clinical medicine ,Diabetes mellitus ,Renal Dialysis ,Risk Factors ,Internal medicine ,medicine ,Vitamin D and neurology ,Humans ,Renal Insufficiency, Chronic ,Vitamin D ,Vascular Calcification ,BGP ,Hemodialysis ,Dialysis ,Aged ,Proportional Hazards Models ,biology ,business.industry ,Warfarin ,Middle Aged ,medicine.disease ,Italy ,biology.protein ,Spinal Fractures ,Female ,business ,medicine.drug - Abstract
Diabetes mellitus is recognized as one of the major causes of end stage kidney disease. Bone Gla protein (BGP) is a vitamin K-dependent protein involved in bone mineralization and vascular calcifications (VC). Our goal was to characterize BGP and undercarboxylated BGP (ucBGP) in DM patients on HD, compared to HD patients without DM, and their association with vascular and bone disease. 387 HD patients from 18 dialysis centers in Italy. Associations of DM, levels of BGP, vitamin D and VC were evaluated. Time-to-event analysis for all-cause mortality was performed by the Kaplan–Meier. Patients with DM had lower levels of total BGP (139.00 vs. 202.50 mcg/L, p
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- 2019
10. FRI0480 CHANGES IN CIRCULATING SCTLA-4 FOLLOWING ZOLEDRONIC ACID INFUSION
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Dario Camellino, Gerolamo Bianchi, G. Girasole, Erika Iervasi, Socrates E. Papapoulos, Daniele Saverino, and Andrea Giusti
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,T cell ,Osteoporosis ,Acute-phase protein ,Renal function ,Bisphosphonate ,medicine.disease ,Gastroenterology ,Zoledronic acid ,Cytokine ,medicine.anatomical_structure ,Internal medicine ,medicine ,Cytotoxic T cell ,business ,medicine.drug - Abstract
Background Acute phase response (APR) is a transient, flu-like reaction to first exposure to intravenous nitrogen-containing bisphosphonate (NBP). APR is characterised by a strong inflammatory response, associated with increases in circulating levels of IL-6 and TNF-, that is thought to be due to activation and increased proliferation of γδ T cells related to the molecular mechanism of action of NBP. Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4), in both its soluble (s) and membrane-bound forms, is involved in the downregulation of T cell proliferation, cell cycle progression and cytokine production. High levels of serum sCTLA-4 have been reported in several autoimmune diseases, and its role as both inhibitor and enhancer of the immune response has been proposed. Objectives To evaluate the potential relationship between sCTLA-4 and the development of APR in patients treated with zoledronic acid (ZOL). Methods Included in the study were patients treated with a single intravenous ZOL infusion 5 mg. Exclusion criteria were previous treatment with ZOL, treatments interfering with CTLA-4, and estimated glomerular filtration rate Results Ten female patients (mean age 73-10 years) were included (2 had vertebral fractures and the remaining had osteoporosis), 5 of whom experienced APR (APR+) associated with the expected increases in serum CRP and IL-6. Baseline levels of sCTLA-4 did not differ between APR+ and APR- patients and decreased significantly in all from 32-9 ng/ml to 24-9 ng/ml (p=0.007) at 24 hr, 16-8 ng/ml (p=0.004) at 48 hr and 7-6 ng/ml (p Conclusion Contrary to our hypothesis, sCTLA-4 was not related to the occurrence of APR after ZOL. The significance of the substantial decrease of circulating levels of sCTLA-4 after ZOL in all studied patients warrants further investigation. Disclosure of Interests Gerolamo Bianchi Consultant for: Alfa-Sigma, Amgen, BMS, Celgene, Medac, UCB, Speakers bureau: Abbvie, Abiogen, Alfa-Sigma, Amgen, BMS, Celgene, Daniele Saverino: None declared, Dario Camellino Consultant for: Janssen-Cilag, Novartis, AbbVie, Sanofi, Paid instructor for: Mylan, Andrea Giusti Grant/research support from: Abiogen Pharma, Consultant for: EffRx, Speakers bureau: Abiogen Pharma, Eli Lilly, AMGEN, Erika Iervasi: None declared, Giuseppe Girasole: None declared, Socrates Papapoulos Grant/research support from: No in the last 3 years, Consultant for: Amgen, Axsome, Gador, Radius Health, UCB, Speakers bureau: Amgen, UCB
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- 2019
11. POS1447 LOW-INTENSITY PULSED ELECTROMAGNETIC FIELDS IMPROVE PHYSICAL PERFORMANCE IN A DOSE-DEPENDENT MANNER: AN OBSERVATIONAL STUDY IN OLDER ADULTS WITH RHEUMATIC DISEASES
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Andrea Giusti, G. Tramontano, R. Galli, S. Rando, M. Giovale, Gerolamo Bianchi, F. Russo, L. Bandi, L. C. Bottaro, and S. Rampoldi
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Electromagnetic field ,medicine.medical_specialty ,business.industry ,Immunology ,Dose dependence ,General Biochemistry, Genetics and Molecular Biology ,Intensity (physics) ,Physical medicine and rehabilitation ,Rheumatology ,Physical performance ,Immunology and Allergy ,Medicine ,Observational study ,business - Abstract
Background:Low-intensity pulsed electromagnetic fields (PEMF) have been shown to improve gait parameters in frail older adults.1 Furthermore, the continuous exposure to PEMF (up to 1 year) have been demonstrated to produce progressive improvements in self-selected gait speed in older adults at risk of falling.2Objectives:To investigate the effects of two different treatment regimens of PEMF on physical performances in older adults presenting with rheumatoid arthritis (RA), osteoarthritis (OA) or severe osteoporosis (OP).Methods:Older adults presenting with RA, OA or OP, at increased risk of falls, evaluated in our Falls Prevention Clinic, were considered for a prospective observational study investigating the effects of PEMF on physical performances. PEMF were supplied by the THS 280 E device (THS-Therapeutic Solutions Srl, Milan, Italy). It provides a new therapeutic approach, named TEPS (Triple Energy Postural Stabilization), that represents an evolution of physical therapy.1,2 On the basis of the physician judgment, PEMF were administered following an intensive protocol, every 45 days (PEMF-45), or a standard validated protocol1,2, every 60 days (PEMF-60). All subjects were assessed at baseline and every 3 months with the following tests: 4 meters gait speed test [4MGS, seconds (sec)], timed up and go test (TUG, sec), chair stand test (CST, sec), short physical performance battery (SPPB, score), and hand grip strength (HGS) by hand dynamometer (Kg). Demographic, anthropometric and clinical characteristics, including pharmacological treatments and functional status were evaluated at baseline. Clinical and adverse events were assessed every 45 or 60 days after PEMF administration.Results:Overall, 94 patients were enrolled between January and December 2020. Of these, 43 subjects (N=33 PEMF-45, N=11 PEMF-60) with a valid 6-month follow-up assessment were considered for the current analysis. The two groups were comparable regarding the main baseline characteristics, and similar % of patients presented with RA, OA or OP. Mean age (±SE) was 78±7 in PEMF-45 and 77±7 in PEMF-60. As expected, all physical performance tests improved significantly from baseline to 6 months in both groups. Mean (±SE) 4MGS increased significantly more in PEMF-45 (from 3.24±0.12 sec to 2.83±0.18 sec) compared to PEMF-60 (from 3.22±0.21 sec to 3.02±0.30 sec, p=.018). Likewise, mean (±SE) CST improved more in PEMF-45 (from 12.4±0.9 sec to 8.7±0.4 sec) compared to PEMF-60 (from 11.1±1.5 sec to 9.8±0.7 sec, p=.002). No significant difference between groups was found for the other tests, although a trend toward better results in PEMF-45 was manifest: SPPB improved by 6.4% in PEMF-45 and by 3.0% in PEMF-60, and TUG decreased by 7.8% in PEMF-45 and by 6.1% in PEMF-60. During the 6 months observation period no adverse event was observed.Conclusion:Preliminary results of our ongoing prospective observational study suggest that a more frequent administration of PEMF produces greater improvements in some but not all physical performance parameters compared to a standard validated regimen1,2.References:[1]Giusti A et al., Geriatr Gerontol Int 2013. 2Giusti A et al., J Am Geriatr Soc 2014.Disclosure of Interests:Massimo Giovale: None declared, Giuseppina Tramontano: None declared, Rossana Galli: None declared, Simone Rando: None declared, Andrea Giusti Speakers bureau: UCB, Amgen, Kyowa Kirin, Abiogen Pharma, and Eli Lilly, outside the submitted work, Consultant of: EffRx and Abiogen Pharma, outside the submitted work, Lorenzo Bandi: None declared, Francesca Russo: None declared, Stefano Rampoldi Employee of: THS Therapeutic Solutions SRL, Luigi Carlo Bottaro: None declared, Gerolamo Bianchi Speakers bureau: Abbvie, Abiogen Pharma, Amgen, BMS, Celgene, Eli Lilly, GSK, Janssen-Cilag, Medac, MSD, Novartis, Pfizer, Roche, Sanofi, Genzyme and Servier, outside the submitted work
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- 2021
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12. AB0379 BARICITINIB IN POLYMYALGIA RHEUMATICA AND GIANT CELL ARTERITIS: REPORT OF SIX CASES
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G. Girasole, Andrea Giusti, Christian Dejaco, Dario Camellino, G. Bianchi, F. Martini, and R. Cosso
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medicine.medical_specialty ,Baricitinib ,business.industry ,Immunology ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Polymyalgia rheumatica ,chemistry.chemical_compound ,Giant cell arteritis ,Tocilizumab ,Rheumatology ,chemistry ,Randomized controlled trial ,Prednisone ,law ,Internal medicine ,medicine ,Immunology and Allergy ,Methotrexate ,Adverse effect ,business ,medicine.drug - Abstract
Background:Glucocorticoids (GC) are the cornerstone of the treatment of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), but they are associated with several adverse events (AEs). Moreover, a considerable proportion of patients relapse during GC tapering.Objectives:To describe the efficacy and safety of the JAK-inhibitor baricitinib (BARI) in a group of patients with PMR and/or GCA.Methods:Case series of patients with PMR and/or GCA with a refractory disease course, despite several lines of therapy, including methotrexate (MTX) and tocilizumab (TCZ), started treatment with BARI. All patients underwent periodic, standardised clinical and laboratory examinations, and also FDG-PET/CT. PMR-activity score (AS) was calculated at each visit except in patients with isolated large vessel vasculitis (LVV) or GCA.Results:A total of six patients (five females and one male, median age 64 years, range 50-83) were treated with BARI. Two of them had isolated PMR (patients #1 and #6), two had PMR with associated LVV (patients #2 and #5), and one (patient #3) had cranial-GCA. Demographic and clinical characteristics are provided in Table 1. At the time of starting BARI, patients were taking a median prednisone dose of 8.75 mg/day (range 0-25), and the 4 patients with PMR±LVV had a median PMR-activity score (PMR-AS) of 23.3 (indicating high disease activity), which decreased to 1.58 after 6 months of treatment with BARI. Two of them could stop GC and continued BARI monotherapy (in one case, BARI was tapered down to 2 mg/day after 12 months).After starting BARI, patient #3 (GCA) could gradually taper prednisone from 25 mg/day to 10 mg/day in six months, without reporting fever or headache. After one year of treatment, she feels well while taking prednisone 7.5 mg/day.Patient #4 (LVV) remained clinically stable during the treatment with BARI, but a follow-up FDG-PET/CT showed LVV, and we decided to stop BARI and restart TCZ. After 4 months of treatment with BARI, patient #5 suffered from pneumonia, while she was also taking prednisone 15 mg/day. BARI was therefore stopped. No other AEs attributable to BARI were detected.Conclusion:BARI appears as an appealing option for treating patients with PMR and/or GCA. Although these preliminary results should be confirmed by a RCT, BARI lowered rapidly disease activity and exerted a significant steroid-sparing effect, allowing GC withdrawal in 2 out of 6 patients.Table 1.Demographic and clinical characteristics of patients.Patient #SexAgeDiagnosisPrevious treatmentDisease duration (months)PMR-AS1F66PMRMTX, HCQ, SSZ25.540.52F78PMR+LVVTCZ, MTX41.828.83F61GCACYC, MMF, TCZ119.8N/A4F60LVVTCZ16.4N/A5F83PMR+LVVMTX, TCZ24.415.26M50PMRMTX24.617.8CYC: cyclophosphamide, GCA: giant cell arteritis, HCQ: hydroxychloroquine, LVV: large vessel vasculitis, MMF: mycophenolate mofetil, MTX: methotrexate, N/A: not applicable, PMR: polymyalgia rheumatica, PMR-AS: PMR-activity score, SSZ: sulfasalazine, TCZ: tocilizumab.Disclosure of Interests:Dario Camellino Speakers bureau: Medac, Eli Lilly, Paid instructor for: Mylan, Consultant of: Accord, Celgene, Novartis, Sanofi, Christian Dejaco Speakers bureau: Eli Lilly (
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- 2021
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13. POS1105 EFFECTS OF CHOLECALCIFEROL AND CALCIFEDIOL IN OSTEOPOROTIC WOMEN WITH SECONDARY HYPERPARATHYROIDISM DUE TO SEVERE VITAMIN D DEFICIENCY UNDERGOING ZOLEDRONIC ACID TREATMENT: A RANDOMIZED-CONTROLLED TRIAL
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F. Santolini, G. Girasole, Andrea Giusti, Dario Camellino, F. Pleitavino, G. Bianchi, G. Botticella, R. Bruno, Monica Pizzonia, Alessio Nencioni, B. Cossu, M. Pedrazzoni, and S. Alexovits
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medicine.medical_specialty ,business.industry ,Immunology ,Parathyroid hormone ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,vitamin D deficiency ,law.invention ,chemistry.chemical_compound ,Zoledronic acid ,medicine.anatomical_structure ,Rheumatology ,Randomized controlled trial ,chemistry ,law ,Internal medicine ,medicine ,Immunology and Allergy ,Secondary hyperparathyroidism ,Calcifediol ,business ,Cholecalciferol ,medicine.drug ,Femoral neck - Abstract
Background:Secondary hyperparathyroidism (sHPTH) due to vitamin D deficiency impairs the bone mineral density (BMD) response to alendronate,1-2 but the optimal strategy for its correction in postmenopausal osteoporotic women (PMO) about to start zoledronic acid (ZOL) therapy is still unknown.Objectives:To evaluate the effects of cholecalciferol (D3) and calcifediol (25OHD) on serum 25-OH-vitamin D (s25OHD), parathyroid hormone (PTH) and BMD in PMO presenting with sHPTH due to vitamin D deficiency.Methods:PMO with s25OHD 65 pg/ml) and BMD T-score at the lumbar spine (LS), femoral neck (FN) or total hip (TH) < -2.5, or between -1 and -2.5 plus one vertebral/femoral fracture, were randomly assigned to receive a therapeutic dose of D3 (300.000 IU bolus) followed by 175 mcg/weekly of D3, or 175 mcg/weekly of 25OHD alone, 2 months before receiving a single intravenous infusion of ZOL (5 mg). BMD at the LS, FN and TH was assessed at baseline and after one year from ZOL. Serum calcium, PTH and s25OHD were measured at baseline, and 6- and 12-month after ZOL. Adverse and clinical events were ascertained by 3-and 9-month telephone interviews, and by 6- and 12-month clinical evaluation.Results:45 PMO (25OHD N=23, D3 N=22) were enrolled over one year and 32 subjects (mean age ±SD 75±10 years, range 51-91) completed the 1-year of treatment/follow-up (25OHD N=17, D3 N=15). Most PMO discontinued for protocol violation, while three deceased before study ending (25OHD N=1, D3 N=2) for reasons not related to the agents investigated. The baseline characteristics were comparable in both groups. At baseline mean s25OHD (±SE) was 8±1 ng/ml in the 25OHD group and 8±1 ng/ml in the D3 group. The corresponding figures for PTH were 111±6 pg/ml (25OHD) and 117±5 pg/ml (D3). Mean s25OHD (±SE) increased in both groups at 6- and 12-month, being significantly greater in the 25OHD group (12-month, 56±2 ng/ml) compared to the D3 group (12-month, 34±2 ng/ml, PConclusion:Calcifediol 175 mcg weekly appears more potent in improving s25OHD and decreasing PTH concentrations compared to cholecalciferol therapeutic dose (300’000 IU) plus 175 mcg weekly in PMO presenting with sHPTH due to severe vitamin D deficiency about to start ZOL therapy. Further studies are warranted to clarify implications on BMD improvements on the long-term of similar 25OHD and D3 regimens.References:[1]Barone A et al., J Am Geriatr Soc 2007.[2]Kincse G et al., BMC Musculoskelet Disord 2012.Disclosure of Interests:Giulia Botticella: None declared, Monica Pizzonia: None declared, Barbara Cossu: None declared, Roberta Bruno: None declared, Dario Camellino Speakers bureau: AbbVie, Celgene, Janssen-Cilag, Eli Lilly, Medac, Mylan, Novartis, and Sanofi, outside the submitted work, Giuseppe Girasole Speakers bureau: Abiogen Pharma and Novartis, outside the submitted work, Andrea Giusti Speakers bureau: UCB, Amgen, Kyowa Kirin, Abiogen Pharma, and Eli Lilly, outside the submitted work, Consultant of: EffRx and Abiogen Pharma, outside the submitted work, Mario Pedrazzoni: None declared, Simona Alexovits: None declared, Franco Pleitavino: None declared, Federico Santolini: None declared, Alessio Nencioni: None declared, Gerolamo Bianchi Speakers bureau: Abbvie, Abiogen Pharma, Amgen, BMS, Celgene, Eli Lilly, GSK, Janssen-Cilag, Medac, MSD, Novartis, Pfizer, Roche, Sanofi, Genzyme, and Servier, outside the submitted work.
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- 2021
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14. Atypical femoral fractures in Italy: a retrospective analysis in a large urban emergency department during a 7-year period (2007–2013)
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B. Abbate, Ignazio Verzicco, Gianfranco Cervellin, G. Girasole, Andrea Giusti, and Mario Pedrazzoni
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medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,Incidence (epidemiology) ,Osteoporosis ,030209 endocrinology & metabolism ,Retrospective cohort study ,General Medicine ,Emergency department ,Femoral fracture ,Rate ratio ,medicine.disease ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Orthopedic surgery ,Medicine ,Orthopedics and Sports Medicine ,Femur ,030212 general & internal medicine ,business - Abstract
The aim of this study was to determine the incidence of atypical femoral fractures (AFFs) seen in a large emergency department in Italy. It was a retrospective study of all men and women aged 40 years or older admitted to the Emergency Department of Parma University Hospital for a femoral fracture. Cases were identified in the hospital database with use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 820 or 821 or text strings. All the radiographic images of fractures not clearly identified as proximal or condylar were retrieved and evaluated by three independent reviewers. Fractures were considered as atypical if all three reviewers agreed on at least four of five major features defined by the 2013 American Society for Bone and Mineral Research criteria. In the 7-year period (2007–2013), with a total follow-up of 1,383,154 patient-years, we found 22 AFFs in 21 patients, accounting for 7.1% of low-trauma subtrochanteric/femoral shaft fractures and 0.6% of all femoral fractures. The incidence was very low (1.6 in 100,000 patient-years in both sexes combined). In contrast, the incidence of classic fractures of the proximal end of the femur was at least two orders of magnitude higher (typical/atypical rate ratio 152). Bisphosphonate use was reported in 13 patients (62%; mean treatment duration 9 years; range 5–14 years). Among 286 patients with typical subtrochanteric/femoral shaft fractures, 20 were being treated with bisphosphonate (7%; odds ratio 22; 95% confidence interval 8–58; p
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- 2016
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15. Management of beta-thalassemia-associated osteoporosis
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Gian Luca Forni, Andrea Giusti, Valeria Pinto, and Alberto Pilotto
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Bone mineral ,medicine.medical_specialty ,Bone density ,business.industry ,General Neuroscience ,medicine.medical_treatment ,Osteoporosis ,030209 endocrinology & metabolism ,Hormone replacement therapy (menopause) ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Bone remodeling ,03 medical and health sciences ,Bone Density Conservation Agents ,0302 clinical medicine ,Denosumab ,History and Philosophy of Science ,030220 oncology & carcinogenesis ,medicine ,Teriparatide ,Physical therapy ,business ,Intensive care medicine ,medicine.drug - Abstract
Beta-Thalassemia-associated osteoporosis is a multifactorial and complex condition. Different acquired and genetic factors are involved in its pathogenesis. These factors produce an imbalance in bone remodeling by inhibiting osteoblast activity and increasing osteoclast function, leading to bone loss and increased fracture risk. The management of patients presenting with thalassemia-associated osteoporosis should consist of the implementation of general measures and the prescription of a specific pharmacological agent, with the aim of reducing fracture risk and preventing disability and deterioration of quality of life. General measures include control of anemia, adequate chelation therapy, healthy nutrition and lifestyle, regular exercise, adequate management of comorbid conditions, hormone replacement therapy in patients with hypogonadism, and vitamin D supplementation/therapy. Among the pharmacological agents currently available for the management of osteoporosis in postmenopausal women and men, bisphosphonates have been shown to improve bone mineral density, to reduce bone turnover, and to decrease bone/back pain in patients with thalassemia-associated osteoporosis, with a good profile of safety and tolerability. On the other hand, there are limited experiences with other pharmacological agents (e.g., denosumab or teriparatide). The complexity of this condition presents diagnostic and therapeutic challenges and underscores the importance of a comprehensive and multidisciplinary approach.
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- 2016
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16. AB0283 REDUCED HOSPITAL ADMISSION IN RA PATIENTS TAPERING BIOLOGIC DMARDS: PRELIMINARY ANALYSIS OF A RETROSPECTIVE STUDY
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G. Bianchi, L. Luca, C. Craviotto, P. Diana, Dario Camellino, T. Caviglia, Andrea Giusti, A. Locaputo, and G. Girasole
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medicine.medical_specialty ,business.industry ,Immunology ,Retrospective cohort study ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Preliminary analysis ,Etanercept ,Rheumatology ,Concomitant ,Rheumatoid arthritis ,Internal medicine ,Hospital admission ,medicine ,Immunology and Allergy ,Outpatient clinic ,Adverse effect ,business ,medicine.drug - Abstract
Background:bDMARDs are among the most effective therapies in the management of inflammatory arthritides, but they are associated with potentially severe adverse events (AEs), particularly infection. Tapering strategies of bDMARDs for patients in remission/low disease activity (R/LDA) have demonstrated comparable efficacy to standard-dose treatments, but their safety profile has not been studied yet.Objectives:To compare the number and the causes of hospital admissions in RA patients in R/LDA continuing or tapering bDMARDs.Methods:Consecutive patients with rheumatoid arthritis (RA) evaluated between 2011 and 2017, were assigned, based on treating physician’s discretion, to continue the standard dose (STD) of bDMARDs or to undergo a predetermined tapering strategy (TAP), after being in R/LDA for two consecutive visits at least 3 months apart. Down-titration of bDMARDs was obtained by a stepwise increase of the dosing interval to achieve a reduction of about 30% (e.g. administration of etanercept every 10 days instead of weekly). Demographic, clinical data and concomitant treatments were retrospectively retrieved from the electronic charts of the outpatient clinics. Information about hospital admissions, including main diagnosis, period and duration of hospitalization, and death were retrieved from the Regional Healthcare System Database.For the STD group, the observation period started with the occurrence of remission and finished with one of these events: loss of remission, switch to another bDMARD, withdrawal of the bDMARD, severe AE, death, end of the study period in (December 2017). For the TAP group, the observation period started with tapering onset and finished with one of these events: reduction of the dosing interval due to either a relapse (according to a DAS28 increase) or to a subjective, symptomatic relapse (according to the patient’s definition), switch to another bDMARD, withdrawal of the bDMARD, severe AE, death, end of the study period in (December 2017).Results:81 patients were included, of whom 40 underwent TAP. Demographic, clinical and treatment data are shown in table 1. Baseline characteristics were comparable between the two groups, except for the number of previous bDMARDs before observational period entry that was slightly higher in the STD group (STD 1.0±0.9 versus TAP 0.5±0.8, P=0.11).Table 1.Baseline demographic and clinical characteristics of the patients in remission or low disease activity.NO TAPERING(n=41)TAPERING(n=40)p valueMean age (yrs)57±1158±130.563Mean disease duration (yrs)12±912±70.897Starting bDMARD to tapering/monitoring (months)52±4567±410.128Mean monitoring period (months)22±2419±230.632Taking sDMARD at any time ((n (%))40 (98%)37 (92%)0.359Taking glucocorticoids29 (71%)28 (70%)0.999Mean prednisone dose (mg/day)2.5±2.92.1±2.70.527DAS28 at the time of tapering or first LDA/REM2.3±0.82.3±0.90.863Previous bDMARDs >1 (n (%))10 (24.4%)4 (10%)0.140In the STD group, 14 hospital admissions occurred, while in the TAP group there were 7 admissions (p=0.128). The corresponding figures for hospital admission due to infectious diseases were 6 in the STD group and 0 in the TAP group (p=0.026).Conclusion:Tapering bDMARDs in RA patients in R/LDA is associated with fewer hospital admissions, with a possible protective effect especially toward infections.Acknowledgments:The authors are indebted with Mrs Rosella Gramuglia and Mrs Cristina Olivieri for the management and analysis of the data on the flow of the drugs, and with Mrs Anna Consigliere, Mrs Anna Cosso, Mrs Romina Petralito and Mrs Laura Ravaschio for helping in retrieving clinical data.Disclosure of Interests:Dario Camellino Consultant of: I have received consultancy fees from Celgene, Sanofi, Novartis, Janssen-Cilag, Accord, Paid instructor for: I have served as a paid instructor for Mylan, Andrea Giusti Consultant of: UCB, Amgen, Janssen, Eli Lilly, Abiogen, EffRx, Speakers bureau: UCB, Amgen, Janssen, Eli Lilly, Abiogen, EffRx, Alfa-Sigma, Chiesi, Giuseppe Girasole: None declared, Chiara Craviotto: None declared, Paola Diana: None declared, Antonia Locaputo: None declared, Tiziana Caviglia: None declared, Lacramioara Luca: None declared, Gerolamo Bianchi Consultant of: Amgen, Janssen, Merck Sharp & Dohme, Novartis, UCB, Speakers bureau: Abbvie, Abiogen, Alfa-Sigma, Amgen, BMS, Celgene, Chiesi, Eli Lilly, GSK, Janssen, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi Genzyme, Servier, UCB
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- 2020
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17. SAT0228 Step-down methotrexate therapy in rheumatoid arthritis (STEMETRA): a pilot study to assess the safety and the tolerability of high-dose methotrexate
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Andrea Giusti, Michael E. Weinblatt, P. Diana, G. Girasole, J. Kremer, Dario Camellino, A. Locaputo, and G. Bianchi
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musculoskeletal diseases ,030203 arthritis & rheumatology ,medicine.medical_specialty ,business.industry ,medicine.disease ,Gastroenterology ,law.invention ,03 medical and health sciences ,Folinic acid ,Route of administration ,0302 clinical medicine ,Tolerability ,Randomized controlled trial ,law ,Internal medicine ,Rheumatoid arthritis ,medicine ,Methotrexate ,030212 general & internal medicine ,Dosing ,Adverse effect ,business ,medicine.drug - Abstract
Background: Methotrexate (MTX) remains the cornerstone of the treatment of rheumatoid arthritis (RA). However, MTX is frequently underutilized in terms of suboptimal dosage, insufficient duration of treatment, and route of administration. Objectives: To evaluate the tolerability and the safety of higher-dose, subcutaneous methotrexate (MTX) in patients with rheumatoid arthritis (RA). Methods: The STEp-down MEthotrexate Therapy in Rheumatoid Arthritis (STEMETRA) was an open-label, monocentric, pilot study of 12-week duration. The protocol treatment schedule consisted of subcutaneous (SC) MTX 50 mg/week for 4 consecutive weeks, followed by 25 mg/week for 4 weeks and then 15 mg/week for 4 weeks. All patients received oral supplementation of folinic acid (leucovorin) 12 mg, administered twelve hours after the injection of SC-MTX. Results: Ten patients (7 females and 3 males), with a mean age of 58.1 (±12.1), were enrolled in this study; one of them withdrew consent before taking study drug. Therefore, nine patients were treated. MTX was well tolerated: a total of 5 adverse events (AEs) occurred in 4 patients, none of which was severe. AEs consisted in: transient elevation of alanine aminotransferase ( 1.2 from baseline. Conclusions: In this study, short-term higher dose MTX was well tolerated. Based on the tolerability observed in this preliminary study, a randomized controlled study of higher dose induction therapy versus traditional dosing will be conducted. Disclosure of Interest: None declared
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- 2018
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18. Clodronate in the management of different musculoskeletal conditions
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Andrea Giusti, Gerolamo Bianchi, Luca Cantarini, Luca Dalle Carbonare, Nazzarena Malavolta, Bruno Frediani, Luigi Molfetta, and Gianantonio Saviola
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0301 basic medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Osteoporosis ,Bone Density Conservation Agents ,Bone Neoplasms ,Clodronic Acid ,Humans ,Muscle Neoplasms ,Musculoskeletal Diseases ,Orthopedic Procedures ,Osteoarthritis ,Cartilage metabolism ,Arthroplasty ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Clodronic acid ,Medicine (all) ,business.industry ,General Medicine ,Bisphosphonate ,medicine.disease ,030104 developmental biology ,Complex regional pain syndrome ,Secondary osteoporosis ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Introduction Clodronic acid is a non-nitrogen-containing bisphosphonate largely used from some decades in the prevention and treatment of postmenopausal and secondary osteoporosis. In addition to antiresorptive activity, clodronate has shown anti-inflammatory and analgesic properties, and modulatory effects on bone and cartilage metabolism. Evidence acquisition A literature review has been conducted to characterize the mechanism of action of clodronate and to retrieve available evidence about the use of clodronate in primary and secondary osteoporosis, and its potential role in other musculoskeletal conditions and orthopedic surgery. Evidence synthesis The efficacy and safety of the available clodronate formulations (oral, intravenous and intramuscular) in the prevention and treatment of postmenopausal and secondary osteoporosis, including corticosteroid-induced osteoporosis and bone mass loss secondary to endocrine, gastrointestinal and neoplastic diseases, have been demonstrated in a variety of clinical trials. The analgesic, anti-inflammatory, bone- and chondro-modulating properties of clodronate have allowed to expand its use in other musculoskeletal conditions to those currently approved. Clodronate has proven to be beneficial in the treatment of osteoarthritis of the knee and of the hand, in the management of complex regional pain syndrome, and in the peri- and postoperative phase in subjects undergoing arthroplasty. Conclusions The analysis of the available literature has shown that clodronate has relevant musculoskeletal effects beyond the antiresorptive activity. Further research is needed to better position clodronate therapy in the management of these conditions and to define the optimal formulation and dose regimen in any of the tested new indications.
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- 2018
19. THU0181 Clinical characteristics of rheumatoid arthritis patients ongoing methotrexate therapy not achieving DAS28 'low diseases activity': a matched case-control analysis from the mari study
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A Severino, F. De Gennaro, Andrea Giusti, T Rossini, Valeria Azzolini, Eleonora Bruschi, N Belai Beyene, Luigi Sinigaglia, N Romeo, M. Manara, LS Martin-Martin, S Corbanese, AB Molica Colella, Pozzi, and G. Bianchi
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musculoskeletal diseases ,medicine.medical_specialty ,Univariate analysis ,business.industry ,Disease ,medicine.disease ,Logistic regression ,Surgery ,immune system diseases ,Rheumatoid arthritis ,Internal medicine ,Cohort ,Case control analysis ,medicine ,Methotrexate ,In patient ,skin and connective tissue diseases ,business ,medicine.drug - Abstract
Background Methotrexate (MTX) is the DMARD of first choice in the treatment of rheumatoid arthritis (RA). Objectives To investigate the clinical characteristics and describe therapeutic approaches in RA patients ongoing MTX not achieving a DAS28 “low disease activity” score. Methods This is a case-control analysis including 186 patients (mean age±SD, 61±12 years, 16% males) who did not achieve a DAS28 “low disease activity” score (defined by a value ≤3.2) and 558 age- and gender-frequency-matched (1:3), randomly selected controls (mean age age±SD, 61±13 years) who achieved a DAS28 “low disease activity” from the original cohort investigated in the MARI study. The MARI study enrolled RA patients on treatment for at least 12-month with MTX. Demographic, clinical, laboratory and pharmacological characteristics of patients recorded at baseline visit were considered for the current analysis. We first compared the characteristics of patients who reached the endpoint with those of subjects who did not by univariate analyses, thereafter, we performed a multivariate model to identify predictors of not achieving the endpoint. We further investigated the therapeutic approaches in patients not achieving the endpoint. Results Compared to patients with a DAS28 ≤3.2, subjects not achieving the endpoint presented with a significant higher (mean±SD) weight and BMI (DAS28 ≤3.2: 25±4 versus DAS28 >3.2: 26±5, P=.022), and longer duration of symptoms (months±SD) before the RA diagnosis (11±15 versus 15±20, P=.009). A higher proportion of subjects within the group not achieving the endpoint presented with polyarticular disease (DAS28 ≤3.2: 57% versus DAS28 >3.2: 96%, P 3.2 (P=.004). In the logistic regression analysis, the variables predictive of a DAS28 >3.2 were polyarticular disease (OR 4.0, 95% CI 2.4–6.7, P 3.2: 13% versus DAS28 ≤3.2: 4%, P Conclusions Our results identified a number of variables potentially associated the risk of not achieving a DAS28 “low disease activity” score in RA patients ongoing MTX treatment. Longitudinal studies are warranted. Disclosure of Interest None declared
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- 2017
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20. Are Dietary Supplements and Nutraceuticals Effective for Musculoskeletal Health and Cognitive Function? A Scoping Review
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Alberto Migliore, Umberto Tarantino, Nicola Napoli, Nazzarena Malavolta, Silvia Migliaccio, Francesca Gimigliano, Andrea Giusti, Prisco Piscitelli, Giovanni Iolascon, Antimo Moretti, Massimiliano Bianco, Giuseppina Resmini, A. de Sire, Raffaele Gimigliano, Iolascon, Giovanni, Gimigliano, Raffaele, Bianco, M., de Sire, A., Moretti, A., Giusti, A., Malavolta, N., Migliaccio, S., Migliore, A., Napoli, N., Piscitelli, P., Resmini, G., Tarantino, U., and Gimigliano, Francesca
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0301 basic medicine ,Gerontology ,medicine.medical_treatment ,Medicine (miscellaneous) ,law.invention ,chemistry.chemical_compound ,Dietary supplement ,Fluorides ,0302 clinical medicine ,Cognition ,Randomized controlled trial ,law ,Dietary supplements ,aging ,cognitive function ,musculoskeletal ,nutraceuticals ,Settore MED/33 - Malattie Apparato Locomotore ,Medicine ,Magnesium ,Micronutrients ,Musculoskeletal Diseases ,Amino Acids ,Vitamin D ,Nutrition and Dietetics ,Vitamin K2 ,Micronutrient ,Zinc ,Italy ,Vitamin B Complex ,nutraceutical ,Vitamin ,medicine.medical_specialty ,030209 endocrinology & metabolism ,Bone and Bones ,03 medical and health sciences ,Nutraceutical ,Fatty Acids, Omega-3 ,Vitamin D and neurology ,Humans ,Vitamin B12 ,Muscle, Skeletal ,Aged ,030109 nutrition & dietetics ,business.industry ,Vitamin E ,Calcium, Dietary ,chemistry ,Dietary Supplements ,Physical therapy ,Potassium ,Geriatrics and Gerontology ,business ,Cognition Disorders - Abstract
Objective: The aim of our scoping review was to summarize the state of the art regarding micronutrients in order to identify which of them might effectively improve health status in the areas typically impaired in older people: bone, skeletal muscle, and cognitive function. Design: Scoping review. Methods: The Italian Study Group on Healthy Aging by Nutraceuticals and Dietary Supplements (HANDS) performed this scoping review, based on the following steps: doing a list of micronutrients related with musculoskeletal or cognitive functions, included in dietary supplements and nutraceuticals commercialized in Italy; planning a research on PubMed, according to an evidence-based approach, in order to the most relevant positive study for each micronutrient into each of the three areas involved (bone, skeletal muscle and cognitive function); identifying the micronutrients effective in maintaining or achieving an adequate health status in older people, specifying the effective and safe daily doses, according to the selected studies. Results: In literature we found 12 relevant positive studies (1 international society guidelines/recommendations, 1 systematic review, 7 randomized controlled trials, and 3 prospective cohort studies). We showed that only 16 micronutrients resulted to have appropriate scientific evidences in terms of improving musculoskeletal health and/or cognitive function in older people: beta-alanine, calcium, creatine, fluorides, leucine, magnesium, omega-3 fatty acids, potassium, vitamin B6, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K2, and zinc. Conclusion: This scoping review showed that selected micronutrients in adequate doses might have an ancillary role in musculoskeletal health and cognitive functions in older people. Objective: The aim of our scoping review was to summarize the state of the art regarding micronutrients in order to identify which of them might effectively improve health status in the areas typically impaired in older people: bone, skeletal muscle, and cognitive function. Design: Scoping review. Methods: The Italian Study Group on Healthy Aging by Nutraceuticals and Dietary Supplements (HANDS) performed this scoping review, based on the following steps: doing a list of micronutrients related with musculoskeletal or cognitive functions, included in dietary supplements and nutraceuticals commercialized in Italy; planning a research on PubMed, according to an evidence-based approach, in order to the most relevant positive study for each micronutrient into each of the three areas involved (bone, skeletal muscle and cognitive function); identifying the micronutrients effective in maintaining or achieving an adequate health status in older people, specifying the effective and safe daily doses, according to the selected studies. Results: In literature we found 12 relevant positive studies (1 international society guidelines/recommendations, 1 systematic review, 7 randomized controlled trials, and 3 prospective cohort studies). We showed that only 16 micronutrients resulted to have appropriate scientific evidences in terms of improving musculoskeletal health and/or cognitive function in older people: beta-alanine, calcium, creatine, fluorides, leucine, magnesium, omega-3 fatty acids, potassium, vitamin B6, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K2, and zinc. Conclusion: This scoping review showed that selected micronutrients in adequate doses might have an ancillary role in musculoskeletal health and cognitive functions in older people.
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- 2017
21. Pseudoxanthoma Elasticum-Like in β-Thalassemia Major, a matter of α-Klotho and Parathyroid Hormone?
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Gian Luca Forni, Cristina Malaventura, Andrea Giusti, Cristina Bosi, Alessandro Baldan, and Caterina Borgna-Pignatti
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Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Clinical Biochemistry ,chemistry.chemical_element ,Parathyroid hormone ,030204 cardiovascular system & hematology ,Calcium ,parathyroid hormone (PTH) ,NO ,Pathogenesis ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,pseudoxanthoma elasticum-like (PXL) ,α-Klotho ,β-thalassemia major (β-TM) ,Hematology ,Genetics (clinical) ,Biochemistry (medical) ,medicine ,Humans ,Pseudoxanthoma Elasticum ,Klotho Proteins ,Klotho ,Glucuronidase ,business.industry ,beta-Thalassemia ,Middle Aged ,α klotho ,Pseudoxanthoma elasticum ,medicine.disease ,030104 developmental biology ,Endocrinology ,chemistry ,Parathyroid Hormone ,Arterial blood ,Female ,business - Abstract
Pseudoxanthoma elasticum-like (PXL) condition is one of the complications faced by patients with β-thalassemia major (β-TM). Histopathological features include abnormal, mineralized and fragmented elastic fibers in skin, eyes and arterial blood vessels (elastorrhexia). The pathogenesis of PXL lesions in β-TM is not yet completely understood. This study was aimed at analyzing a possible implication of α-Klotho in the clinical manifestation of PXL in patients with β-TM (30 with and 78 without PXL). A significant correlation was observed between Klotho, parathyroid hormone (PTH) and serum calcium (Ca). Our analysis seems to indicate α-Klotho and PTH as factors that can affect the development of PXL.
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- 2017
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22. Identifying a standard set of outcome parameters for the evaluation of orthogeriatric co-management for hip fractures
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J Burton, Norbert Suhm, Frankie Leung, I. S. L. Liem, G Pioli, Michael Blauth, Christopher G. Moran, Stephen L. Kates, M. Gosch, Andrea Giusti, Martyn J. Parker, Daniel A. Mendelson, T. Roth, Joseph D. Zuckerman, Christian Kammerlander, A Hoang-Kim, and Jörg Goldhahn
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Male ,medicine.medical_specialty ,Activities of daily living ,Health Services for the Aged ,Frail Elderly ,Osteoporosis ,Population ,Outcome (game theory) ,Quality of life (healthcare) ,Surveys and Questionnaires ,Activities of Daily Living ,Preoperative Care ,Humans ,Medicine ,Orthopedic Procedures ,Set (psychology) ,education ,Geriatric Assessment ,Aged ,General Environmental Science ,Aged, 80 and over ,Patient Care Team ,Postoperative Care ,education.field_of_study ,Hip fracture ,Hip Fractures ,business.industry ,Recovery of Function ,Length of Stay ,medicine.disease ,Outcome parameter ,Hospitalization ,Patient Outcome Assessment ,Physical therapy ,General Earth and Planetary Sciences ,Female ,business ,Osteoporotic Fractures - Abstract
Summary Background and purpose Osteoporotic fractures are an increasing problem in the world due to the ageing of the population. Different models of orthogeriatric co-management are currently in use worldwide. These models differ for instance by the health-care professional who has the responsibility for care in the acute and early rehabilitation phases. There is no international consensus regarding the best model of care and which outcome parameters should be used to evaluate these models. The goal of this project was to identify which outcome parameters and assessment tools should be used to measure and compare outcome changes that can be made by the implementation of orthogeriatric co-management models and to develop recommendations about how and when these outcome parameters should be measured. It was not the purpose of this study to describe items that might have an impact on the outcome but cannot be influenced such as age, co-morbidities and cognitive impairment at admission. Methods Based on a review of the literature on existing orthogeriatric co-management evaluation studies, 14 outcome parameters were evaluated and discussed in a 2-day meeting with panellists. These panellists were selected based on research and/or clinical expertise in hip fracture management and a common interest in measuring outcome in hip fracture care. Results We defined 12 objective and subjective outcome parameters and how they should be measured: mortality, length of stay, time to surgery, complications, re-admission rate, mobility, quality of life, pain, activities of daily living, medication use, place of residence and costs. We could not recommend an appropriate tool to measure patients’ satisfaction and falls. We defined the time points at which these outcome parameters should be collected to be at admission and discharge, 30 days, 90 days and 1 year after admission. Conclusion Twelve objective and patient-reported outcome parameters were selected to form a standard set for the measurement of influenceable outcome of patients treated in different models of orthogeriatric co-managed care.
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- 2013
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23. Interactions between vitamin D and IGF-I: from physiology to clinical practice
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Diego Ferone, Andrea Giusti, Giovanni Murialdo, Mara Boschetti, Francesco Minuto, and Pietro Ameri
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Vitamin ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Population ,chemistry.chemical_element ,Calcium ,Biology ,Models, Biological ,Bone remodeling ,Paracrine signalling ,chemistry.chemical_compound ,Endocrinology ,Internal medicine ,Paracrine Communication ,medicine ,Vitamin D and neurology ,Humans ,Endocrine system ,Insulin-Like Growth Factor I ,Vitamin D ,Autocrine signalling ,education ,education.field_of_study ,Human Growth Hormone ,Autocrine Communication ,Insulin-Like Growth Factor Binding Protein 3 ,chemistry - Abstract
The interplay between vitamin D and IGF-I is complex and occurs at both endocrine and paracrine/autocrine levels. Vitamin D has been shown to increase circulating IGF-I and IGFBP-3, with the consistent finding of a positive correlation between vitamin D and IGF-I serum values in population-based cohorts of healthy subjects. The modulation of IGF-I and IGFBP-3 concentrations by vitamin D may impact recombinant human (rh) GH dosing for the treatment of GHD. It might also underlie some of the extra-skeletal beneficial effects ascribed to vitamin D. On the other hand, IGF-I stimulates renal production of 1,25-dihydroxyvitamin D, which increases calcium and phosphate availability in the body and suppresses PTH secretion. This effect is responsible for an altered calcium-phosphate balance in uncontrolled acromegaly and might also account for the improvement in bone metabolism associated with rhGH treatment in patients with GHD. Data on the paracrine/autocrine vitamin D-IGF-I interactions are abundant, but mostly not linked to one another. As a result, it is not possible to draw a comprehensive picture of the physiological and/or pathological interrelations between vitamin D, IGF-I and IGF-binding proteins (IGFBP) in different tissues. A potential role of vitamin D action is related to its association with carcinogenesis, a paradigm being breast cancer. Current evidence indicates that, in breast tumours, vitamin D modulates the IGF-I/IGFBP ratio to decrease proliferation and increase apoptosis.
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- 2013
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24. Guidelines for the diagnosis, prevention and management of osteoporosis
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Francesco Bertoldo, Mario Pedrazzoni, Silvano Adami, Ombretta Viapiana, G Osella, Luigi Sinigaglia, Nazzarena Malavolta, Salvatore Minisola, Maurizio Rossini, Sandro Giannini, Andrea Giusti, D. Diacinti, Davide Gatti, and Gc Isaia
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lcsh:Internal medicine ,medicine.medical_specialty ,Cost effectiveness ,Population ,Specific risk ,rheumatology ,lcsh:Medicine ,030209 endocrinology & metabolism ,Guidelines ,dual-energy x-ray absorptiometry ,fractures ,guidelines ,osteoporosis ,risk factors ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Absorptiometry, Photon ,Meta-Analysis as Topic ,Bone Density ,medicine ,Humans ,030212 general & internal medicine ,lcsh:RC31-1245 ,Intensive care medicine ,education ,Societies, Medical ,education.field_of_study ,Evidence-Based Medicine ,business.industry ,Incidence ,lcsh:R ,Evidence-based medicine ,Systematic review ,Italy ,Good clinical practice ,Physical therapy ,Secondary osteoporosis ,Risk assessment ,business ,Osteoporotic Fractures - Abstract
Osteoporosis poses a significant public health issue. National Societies have developed Guidelines for the diagnosis and treatment of this disorder with an effort of adapting specific tools for risk assessment on the peculiar characteristics of a given population. The Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) has recently revised the previously published Guidelines on the diagnosis, riskassessment, prevention and management of primary and secondary osteoporosis. The guidelines were first drafted by a working group and then approved by the board of SIOMMMS. Subsequently they received also the endorsement of other major Scientific Societies that deal with bone metabolic disease. These recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on leading experts’ experience and opinion, and on good clinical practice. The osteoporosis prevention should be based on the elimination of specific risk factors. The use of drugs registered for the treatment of osteoporosis are recommended when the benefits overcome the risk, and this is the case only when the risk of fracture is rather high as measured with variables susceptible to pharmacological effect. DeFRA (FRAX® derived fracture risk assessment) is recognized as a useful tool for easily estimate the long-term fracture risk. Several secondary forms of osteoporosis require a specific diagnostic and therapeutic management.
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- 2016
25. Short-term effect of low-intensity, pulsed, electromagnetic fields on gait characteristics in older adults with low bone mineral density: A pilot randomized-controlled trial
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Gerolamo Bianchi, Armando De Vincentiis, Massimo Giovale, Marco Ponte, Andrea Giusti, Francesco Fratoni, and Umberto Tortorolo
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Bone mineral ,medicine.medical_specialty ,Bone density ,business.industry ,Osteoporosis ,medicine.disease ,Placebo ,Gait ,law.invention ,Intensity (physics) ,Physical medicine and rehabilitation ,Randomized controlled trial ,law ,medicine ,Physical therapy ,business ,human activities ,Fall prevention - Abstract
Aim: To evaluate the short-term effects of a 10-min exposure to low-intensity, pulsed, electromagnetic fields (PEF) on gait characteristics in older adults with low bone mineral density. Methods: In a single-center, double-blind, randomized-controlled trial, community-dwelling older adults aged ≥70 years were randomized (3:2 ratio) to receive a 10-min treatment with PEF (mean intensity 1.5 mW) or placebo. The following gait parameters were assessed at baseline and just after the intervention/placebo with the GAITRite Portable Walkway system: self-selected gait speed (cm/s), stride length (cm), support base (cm) and double support phase (s). Results: In the intervention group (25 patients), both self-selected gait speed and stride length increased significantly from baseline, whereas the double support phase decreased. In the placebo group, all gait parameters except for support base remained unchanged. The mean percent increase (±standard deviation) of self-selected gait speed was significantly (P = 0.010) greater in the intervention group (20.1 ± 15.6) compared with the placebo group (10.5 ± 13.1), whereas no significant difference in the mean percent variation of the other parameters was found between the two groups. During the intervention, no adverse event was observed. A similar proportion of patients in the two groups reported one fall in the 30 days after the intervention/placebo. Conclusions: This is the first randomized-controlled trial showing the potential beneficial effects of PEF on gait characteristics in older adults. Further phase III randomized trials are warranted to establish their potential benefits (e.g. fall prevention) on fall-related health outcomes in elderly patients. Geriatr Gerontol Int 2013; 13: 393–397.
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- 2012
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26. Pharmacokinetic and Pharmacodynamic Comparative Study of Zofenopril and Enalapril in Healthy Volunteers
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Paolo Mazzucchelli, Lorenzo Dal Bo, Shevqet Ismaili, Mario Richard Uhr, Fabrizio Crivelli, Andrea Giusti, Nunzia Ceppi Monti, and Antonio Marzo
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Adult ,Male ,medicine.medical_specialty ,Captopril ,Enalaprilat ,Angiotensin-Converting Enzyme Inhibitors ,Blood Pressure ,Peptidyl-Dipeptidase A ,Pharmacology ,Zofenopril Calcium ,chemistry.chemical_compound ,Enalapril ,Pharmacokinetics ,Heart Rate ,Internal medicine ,Drug Discovery ,medicine ,Humans ,Biotransformation ,Chromatography, High Pressure Liquid ,biology ,Angiotensin-converting enzyme ,Zofenopril ,Endocrinology ,chemistry ,Enalapril Maleate ,Area Under Curve ,ACE inhibitor ,biology.protein ,Female ,medicine.drug - Abstract
Zofenopril calcium (CAS 81938-43-4) is a new angiotensin converting enzyme (ACE) inhibitor, which in addition to the typical activity of the class, proved to possess a specific cardioprotective effect due also to the presence of the sulfhydryl group. In this trial zofenopril calcium and enalapril maleate (CAS 76095-16-4) were given to 20 healthy volunteers of both sexes in repeated dose regiment at two dose levels: 30 mg and 60 mg zofenopril calcium and 10 mg and 20 mg enalapril maleate. The study was conducted according to a two-period, two-sequence, crossover design, with washout. ACE activity in serum and zofenopril, zofenoprilat, enalapril and enalaprilat plasma concentrations were determined during and on the last day of the two study periods. Both zofenopril and enalapril were extensively converted through hydrolysis to their active metabolites zofenoprilat and enalaprilat, respectively. Zofenopril exhibited a complete and a more rapid hydrolysis rate compared to enalapril, which is reflected by the higher metabolite to parent drug ratio of C max and AUC ss,t showed by this compound. Even though only two dose levels were investigated in this trial, the pharmacokinetics of both drugs seem to be linear. In line with previous trials, both compounds at both dose levels investigated produced complete or almost complete inhibition of ACE activity in serum, for a period lasting 6–8 h after administration, the inhibition being still relevant 24 h thereafter. The tolerability of the two drugs at both dose levels proved to be very good as demonstrated by subjective and objective symptoms, by the absence of relevant adverse events, and by laboratory biochemical parameters and vital signs evaluated before and after the trial. Blood pressure showed a fairly decreasing trend with both the drugs, systolic and diastolic blood pressure values being however within normal range in all the subjects. In no case symptoms of hypotension were experienced. In conclusion, zofenopril calcium and enalapril maleate show very good tolerability and appear to exert similar activity on serum ACE. The main difference in the pharmacokinetics of the two compounds is the conversion from pro-drug to the active metabolite which is faster with zofenopril.
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- 2011
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27. Atypical fractures of the femur and bisphosphonate therapy
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Andrea Giusti, Neveen A. T. Hamdy, and Socrates E. Papapoulos
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medicine.medical_specialty ,Pediatrics ,Histology ,Physiology ,business.industry ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Osteoporosis ,MEDLINE ,Bisphosphonate ,medicine.disease ,Surgery ,Meta-analysis ,medicine ,Insufficiency fracture ,In patient ,Femur ,Bisphosphonate therapy ,business - Abstract
Atypical fractures of the femur below the lesser trochanter have been reported in patients treated with bisphosphonates. We performed a systematic literature search of case/case series studies to better define the clinical presentation and to identify characteristics that may predispose patients to such fractures. We considered only women treated with a bisphosphonate at a dosing regimen used for the prevention or treatment of osteoporosis and we included also eight own unpublished cases. We identified 141 women with atypical fractures of the femur, mean age of 67.8+/-11.0 years, who were treated with bisphosphonate for 71.5+/-40.0 months (range=3-192 months). The results of this analysis allow identification of patients on bisphosphonate treatment at risk of developing atypical fractures, define fractures better as predominantly insufficiency fractures, illustrate that long-term bisphosphonate treatment is not a prerequisite for their development, recognize the use of glucocorticoids and proton pump inhibitors as important risk factors, but do not provide insights in the pathogenesis of these fractures and raise questions that need to be addressed in properly designed studies.
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- 2010
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28. Heterogeneity in Serum 25-Hydroxy-Vitamin D Response to Cholecalciferol in Elderly Women with Secondary Hyperparathyroidism and Vitamin D Deficiency
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Monica Pizzonia, Monica Razzano, G. Girasole, Andrea Giusti, Mario Pedrazzoni, Antonella Barone, Giulio Pioli, Ernesto Palummeri, and Gerolamo Bianchi
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medicine.medical_specialty ,Hyperparathyroidism ,business.industry ,Parathyroid hormone ,medicine.disease ,vitamin D deficiency ,Urinary calcium ,chemistry.chemical_compound ,Endocrinology ,N-terminal telopeptide ,chemistry ,Internal medicine ,medicine ,Vitamin D and neurology ,Secondary hyperparathyroidism ,Geriatrics and Gerontology ,business ,Cholecalciferol - Abstract
OBJECTIVES: To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol. DESIGN: Randomized-controlled trial with 6-month follow-up. SETTING: Two osteoporosis centers in northern Italy. PARTICIPANTS: Sixty community-dwelling women aged 65 and older with sHPTH and hypovitaminosis D, creatinine clearance greater than 65 mL/min and without diseases or drugs known to influence bone and vitamin D metabolism. INTERVENTION: Cholecalciferol 300,000 IU every 3 months, once at baseline and once at 3 months (intermittent D3 group) or cholecalciferol 1,000 IU/day (daily D3 group). MEASUREMENTS: Serum PTH, 25(OH)D, calcium, bone-specific alkaline phosphatase, β-C-terminal telopeptide of type I collagen, phosphate, 24-hour urinary calcium excretion. RESULTS: The two groups had similar baseline characteristics. All participants had vitamin D deficiency [25(OH)D
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- 2010
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29. Hot topics from the 4th International Conference on Osteoporosis in Men
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Andrea Giusti, Ernesto Palummeri, Gerolamo Bianchi, and G. Girasole
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Gerontology ,education.field_of_study ,medicine.medical_specialty ,business.industry ,Population ,Osteoporosis ,medicine.disease ,Hot topics ,Rheumatology ,Risk indicators ,Economic cost ,Physical therapy ,Western world ,Medicine ,education ,business - Abstract
With the aging of the population worldwide, osteoporotic fractures are becoming a serious problem in the Western world. Male osteoporosis is associated with a significant burden in terms of morbidity, mortality and economic cost. Although less frequent in men than women, osteoporosis is a relatively common problem. The increasing prevalence and awareness of osteoporosis and fractures in men, together with the development of easy-to-measure tools and risk indicators to optimize case-finding strategies, has increased the demand for a better understanding of the pathogenesis of this condition and, in turn, for appropriate and effective treatments. This article reports recent findings regarding the pathophysiology and treatment of male osteoporosis that have been discussed by some of the most outstanding scientists in this field at a meeting held in Santa Margherita, Italy, on 6–8 November 2008.
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- 2009
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30. Alendronate and indapamide alone or in combination in the management of hypercalciuria associated with osteoporosis: a randomized controlled trial of two drugs and three treatments
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G. Girasole, Gerolamo Bianchi, Andrea Giusti, Antonella Barone, Ernesto Palummeri, Vincenzo Siccardi, and Giulio Pioli
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medicine.medical_specialty ,medicine.medical_treatment ,Hypercalciuria ,Osteoporosis ,Urology ,Bone Density ,Internal medicine ,medicine ,Humans ,Diuretics ,Osteoporosis, Postmenopausal ,Thiazide ,Aged ,Femoral neck ,Transplantation ,Alendronate ,Bone Density Conservation Agents ,Dose-Response Relationship, Drug ,business.industry ,Alendronic acid ,Indapamide ,Middle Aged ,medicine.disease ,Urinary calcium ,Endocrinology ,medicine.anatomical_structure ,Nephrology ,Calcium ,Drug Therapy, Combination ,Female ,Diuretic ,business ,medicine.drug - Abstract
BACKGROUND The role of bisphosphonates (BPs) in the management of patients with hypercalciuria (HC) associated with osteoporosis is still uncertain. The aim of the study was to evaluate the effect of alendronate and indapamide alone or in combination on bone mineral density (BMD) and 24-h urinary calcium excretion (24-CaU) in post-menopausal women with HC and low BMD. METHODS A total of 77 post-menopausal women with HC (24-CaU > 4 mg/kg/day) and low BMD [T-score < -2.0 at lumbar spine (LS), femoral neck (FN) or total hip (TH)] from two centres of Northern Italy were randomized to receive indapamide 2.5 mg daily alone (24 patients, IND group), alendronate 70 mg weekly alone (27 patients, ALN group) or the combination therapy (26 patients, ALN + IND group). Throughout the study, all subjects received daily calcium supplements, depending on their dietary intake, to maintain a daily input of 1000 mg. Patients were instructed to increase water intake up to 2000 mL daily. The percentage and absolute changes of BMD at LS, FN and TH, and the variation of 24-CaU from baseline at 1 year were the primary outcomes. Serum calcium, phosphate, parathyroid hormone and bone alkaline phosphatase were also measured. RESULTS Overall 67 women completed the study and were included in the final analysis. Patients in the three groups were similar with regard to baseline characteristics. BMD did not significantly change from baseline after 1 year of treatment with indapamide (LS: +1 +/- 3.1%; FN: -0.3 +/- 3.5%; TH: -0.4 +/- 3.1%), while it showed a significant increase from baseline in the other two groups (ALN; LS: +5.8 +/- 4.2%, P < 0.001; FN: +3.9 +/- 7.9%, P = 0.018; TH: +2 +/- 3.6%, P = 0.006) (ALN + IND; LS: +8.2 +/- 5.3%, P < 0.001; FN: +4.9 +/- 6.7%, P = 0.007; TH: +2.9 +/- 4.2%, P = 0.004). Patients in the combination group showed a significantly higher increase of BMD at LS compared to ALN (P = 0.04). After 1 year, 24-CaU values significantly decreased from baseline in all groups (IND, 239 +/- 78 versus 364 +/- 44, P < 0.001) (ALN, 279 +/- 68 versus 379 +/- 79, P < 0.001) (ALN + IND, 191 +/- 68 versus 390 +/- 55, P < 0.001). The mean percentage decrease of 24-CaU in ALN + IND group (-50%) was significantly greater compared to ALN (-24%, P < 0.001) and IND (-35%, P = 0.012). CONCLUSIONS These results show a benefit, in terms of BMD improvement and 24-CaU reduction, associated with BPs' therapy in combination with indapamide in HC associated with osteoporosis. The combination therapy demonstrated a reduction of 24-CaU and an increase in LS BMD superior to that observed with alendronate alone. Our results support a new potential approach with BPs associated with thiazide diuretics or indapamide in the management of post-menopausal women with HC and associated bone loss. Studies on the larger sample size are needed to demonstrate the efficacy on the fracture outcome.
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- 2008
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31. Persistence with calcium and vitamin D in elderly patients after hip fracture
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Andrea Giusti, Ernesto Palummeri, Monica Pizzonia, Giulio Pioli, Mauro Oliveri, Antonella Barone, and Monica Razzano
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Adult ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Osteoporosis ,Endocrinology ,Internal medicine ,medicine ,Vitamin D and neurology ,Humans ,Dementia ,Orthopedics and Sports Medicine ,Vitamin D ,Medical prescription ,Aged ,Aged, 80 and over ,Univariate analysis ,Hip fracture ,Hip Fractures ,business.industry ,Medical record ,General Medicine ,Bisphosphonate ,medicine.disease ,Calcium, Dietary ,Dietary Supplements ,Physical therapy ,Patient Compliance ,Female ,business - Abstract
All hip fracture (HF) subjects are candidates for calcium and vitamin D (CaD) supplementation. Up to 50% of HF older adults present with secondary hyperparathyroidism (HPTH) resulting from hypovitaminosis D on hospital admission. To investigate the patterns and predictors of persistence with CaD supplementation in the elderly after HF, we considered all patients aged 70 years or older who were discharged alive after surgical repair of HF in the period of 1 year from an Orthopaedic Unit. Baseline characteristics of the subjects and osteoporosis treatment prescribed at discharge were retrieved from medical record review. A telephone interview at 6 months evaluated whether patients were currently taking CaD supplementation. Nonpersistence was defined when subjects ceased therapy within 6 months. Univariate and multivariate models were applied to determine the relationship between 6 months persistence with CaD and the variables collected: age, living situation, prescription of a bisphosphonate, baseline walking ability, number of drugs used, presence of dementia, number of active clinical issues at discharge (ACIs), discharge location, and being referred to a center for metabolic bone diseases (preplanned visit) at discharge. Of 428 subjects enrolled, 117 were excluded for different reasons (incomplete data, no therapy, death). A total of 311 subjects were discharged with a prescription of CaD (calcium 1,000 mg, cholecalciferol 800 UI, once daily) and were considered for the analysis. At 6 months, only 114 patients (36.7%) were currently taking CaD supplementation. In a univariate analysis, the following variables were significantly related with persistence: absence of dementia, prescription of a bisphosphonate, six or fewer drugs being used (drugs usedor=6), two or less ACIs (or=2 ACIs) at discharge, ability to walk without aid at baseline, being discharged home, and being referred to a preplanned visit. In a multivariate model, the prescription of a bisphosphonate at discharge (OR 3.178, 95% CI 1.477-6.836, P = 0.003), a preplanned visit (OR 1.953, 95% CI 1.066-3.514, P = 0.03), the absence of dementia (OR 1.877, 95% CI 1.021-3.451, P = 0.043), andor=6 drugs used (OR 1.842, 95% CI 1.066-3.182, P = 0.029) remained the most significant predictors of persistence with CaD. In HF elderly, who are at high risk of hypovitaminosis D and HPTH, persistence with CaD supplementation is very low. The enrolment in a postsurgical program for the management of bone disease can significantly increase persistence. Moreover, factors related to the complexity of older adult patients (polypharmacotherapy, dementia) seem to be particularly important in compliance with prescribed drugs.
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- 2008
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32. Secondary Hyperparathyroidism Due to Hypovitaminosis D Affects Bone Mineral Density Response to Alendronate in Elderly Women with Osteoporosis: A Randomized Controlled Trial
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Ernesto Palummeri, Andrea Giusti, Gerolamo Bianchi, Monica Pizzonia, G. Girasole, Monica Razzano, Antonella Barone, and Giulio Pioli
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musculoskeletal diseases ,Hyperparathyroidism ,medicine.medical_specialty ,Bone density ,business.industry ,Alendronic acid ,Osteoporosis ,Urology ,medicine.disease ,vitamin D deficiency ,Endocrinology ,medicine.anatomical_structure ,Internal medicine ,medicine ,Vitamin D and neurology ,Secondary hyperparathyroidism ,Geriatrics and Gerontology ,business ,Femoral neck ,medicine.drug - Abstract
OBJECTIVES: To determine whether secondary hyperparathyroidism (HPTH) due to hypovitaminosis D affects bone mineral density (BMD) response to alendronate (ALN) in elderly women with osteoporosis. DESIGN: Randomized, controlled trial with 1-year follow-up. SETTING: Two osteoporosis centers in northern Italy. PARTICIPANTS: Community-dwelling women aged 60 and older with a BMD T-score below -2.5 and secondary HPTH with vitamin D insufficiency. INTERVENTION: One hundred twenty subjects were randomly assigned to receive ALN 70 mg once a week alone or ALN 70 mg once a week plus calcitriol (1,25D3) 0.5 microg daily. MEASUREMENTS: BMD measured using dual-energy x-ray absorptiometry at the lumbar spine (L1-L4), femoral neck, and total hip and serum levels of intact PTH at baseline and 12 months. RESULTS: After 1 year, BMD of the lumbar spine, femoral neck, and total hip significantly increased from baseline in both groups (P
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- 2007
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33. Optimal setting and care organization in the management of older adults with hip fracture: a narrative review
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Andrea Del Rio, Mauro Oliveri, Alberto Pilotto, Rita Raiteri, Monica Razzano, Andrea Giusti, Antonella Barone, E. Palummeri, and Viviana Bassoli
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Gerontology ,medicine.medical_specialty ,Hip fracture ,orthogeriatric ,business.industry ,lcsh:Geriatrics ,medicine.disease ,lcsh:RC952-954.6 ,Quality of life (healthcare) ,Multidisciplinary approach ,aged ,Health care ,Orthopedic surgery ,Life expectancy ,Physical therapy ,Medicine ,business ,Set (psychology) ,Early discharge - Abstract
Hip fracture (HF) is a common event in older adults and is associated with significant morbidity, mortality, reduction of quality of life and costs for the healthcare systems. The expected rise in the total number of HF worldwide, due to improvements in life expectancy, and the growing awareness of HF detrimental consequences have led to the development and implementation of models of care alternative to the traditional ones for the acute and post-acute management of HF older adults. These services were set to streamline hospital care, minimize inhospital complications, provide early discharge, improve short- and long-term functional and clinical outcomes, and reduce healthcare costs associated with hip and other fragility fractures. The main feature that distinguishes these models is the different healthcare professional that retains the responsibility and leadership during the acute and post-acute phases. This narrative review has been conceived to provide a brief description of the models implemented in the last twenty years, to describe their potential beneficial effects on the shortand long-term outcomes, and to define the strengths and limitations of these models. On the basis of available studies, it seems that the more complex and sophisticated services, characterized by a multidisciplinary approach with a co-leadership (geriatrician and orthopedic surgeon) or a geriatrician leadership demonstrated to produce better outcomes compared to the traditional or simplest models.
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- 2015
34. An Analysis of the Feasibility of Home Rehabilitation Among Elderly People With Proximal Femoral Fractures
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Andrea Giusti, Ernesto Palummeri, Giulio Pioli, Mauro Oliveri, Monica Razzano, Monica Pizzonia, and Antonella Barone
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Male ,medicine.medical_specialty ,Activities of daily living ,medicine.medical_treatment ,Physical Therapy, Sports Therapy and Rehabilitation ,Statistics, Nonparametric ,Activities of Daily Living ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Aged ,Aged, 80 and over ,Analysis of Variance ,Hip fracture ,Chi-Square Distribution ,Rehabilitation ,business.industry ,Odds ratio ,medicine.disease ,Home Care Services ,Confidence interval ,Treatment Outcome ,Physical therapy ,Feasibility Studies ,Female ,business ,Femoral Fractures ,Chi-squared distribution ,Cohort study - Abstract
Giusti A, Barone A, Oliveri M, Pizzonia M, Razzano M, Palummeri E, Pioli G. An analysis of the feasibility of home rehabilitation among elderly people with proximal femoral fractures. Objective To evaluate the feasibility and predictors of success of home-based rehabilitation (HBR) in older adults after hip fracture. Design Prospective inception cohort study with 12 months of follow-up. Setting Acute and subacute care with follow-up in a community setting in Italy. Participants Community-dwelling older adults (N=199) aged 70 years or older, discharged from an acute orthopedic unit after repair of a nontraumatic proximal femoral fracture. Interventions Patients' choice of pursuing HBR or institutional-based rehabilitation (IBR). Main Outcome Measures Proportion of subjects discharged home for rehabilitation. Rates of institutionalization assessed at 3, 6, and 12 months postdischarge. Mean changes of the Barthel Index from baseline and proportion of subjects who regained their prefracture levels of function at the time of follow-up in the 2 intervention groups (HBR, IBR). Results Ninety-nine (49.7%) patients chose HBR, and the rest (50.3%) were discharged to a rehabilitation facility. With regard to the baseline characteristics, the 2 patient groups (HBR, IBR) differed with respect to living arrangement ( P ≤.001), prefracture functional status in basic (Barthel Index, P =.033; Katz Index, P =.041) and instrumental activities of daily living (IADLs) ( P =.041), and occurrence of delirium ( P =.022). During the follow-up, the number of subjects institutionalized at 3, 6, and 12 months was 52, 26, and 22, respectively. In the multiple logistic regression model, the only significant variable affecting the choice of IBR at discharge was the absence of relatives at home (odds ratio [OR], 6.7; 95% confidence interval [CI], 3.33–13.46; P ≤.001), whereas a prefracture functional impairment in more than 3 IADLs (at 12mo: OR=3.99; 95% CI, 1.57–10.18; P =.004), the absence of relatives at home (at 12mo: OR=8.81; 95% CI, 2.47–31.46; P =.001), and delay to surgery longer than 3 days (at 12 mo: OR=5.51; 95% CI, 1.28–23.81; P =.022) resulted in significant risk factors for long-term institutionalization. Compared with subjects who received traditional rehabilitation, those discharged home showed—after controlling for prefracture Barthel Index score, IADLs, cognitive status and age—a slightly lower functional decline and a higher rate of recovery during the follow-up (mean change in Barthel Index score ± standard deviation at 12mo: HBR, −11.2±24.7 vs IBR, −23.7±28.5; P =.015). Conclusions In an unselected population of hip-fractured older adults previously living in the community, HBR seems to be a feasible alternative to IBR in those subjects living with relatives.
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- 2006
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35. Blockade of P-Selectin Does Not Affect Reperfusion Injury in Hamsters Subjected to Glutathione Inhibition
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Silvia Bertuglia and Andrea Giusti
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Blood Platelets ,Male ,medicine.medical_specialty ,Time Factors ,P-selectin ,Ischemia ,Hamster ,Biology ,Biochemistry ,Microcirculation ,chemistry.chemical_compound ,Cheek pouch ,Cricetinae ,Internal medicine ,Cell Adhesion ,Leukocytes ,medicine ,Animals ,Platelet ,Enzyme Inhibitors ,Buthionine Sulfoximine ,Mesocricetus ,Cell Biology ,Glutathione ,medicine.disease ,Capillaries ,Perfusion ,P-Selectin ,Cheek ,Endocrinology ,chemistry ,Reperfusion Injury ,Immunology ,Cardiology and Cardiovascular Medicine ,Reperfusion injury - Abstract
P-selectin antibody has been shown to prevent microvascular damage after ischemia reperfusion (I/R). We investigated whether the treatment with anti-P-selectin would attenuate the decrease in capillary perfusion after glutathione (GSH) inhibition in hamster cheek pouch microcirculation subjected to I/R. Animals were treated for 3 days with l -buthionine-[ S,R ]-sulfoximine (BSO) to inhibit GSH synthesis. P-selectin expression was determined by using an in situ immunofluorescence method in the microvessels. Ischemia was induced by clamping the cheek pouch for 30 min followed by 30 min of reperfusion. Changes in capillary perfusion, RBC velocity, and leukocyte and platelet adhesion on microvessels were measured after I/R. Hamsters subjected to I/R showed increased leukocyte and platelet adhesion as well as decreased capillary perfusion. The anti-P-selectin group showed a significant P-selectin expression, that occurs at the venular bifurcations within 15–30 min of reperfusion, as well as no increase in leukocyte and platelet adhesion on microvessels. BSO partially prevented P-selectin expression but the decrease in capillary perfusion and the increase in both platelet and leukocyte adhesion in microvessels were greater. GSH significantly prevented P-selectin expression as well as capillary perfusion decrease after I/R. In conclusion, GSH inhibition blunted the protective effects of anti-P-selectin treatment with marked leukocyte adhesion on postcapillary venules and platelet–endothelial cell interactions in arterioles and venules and decreased capillary perfusion at reperfusion, thus suggesting that the mechanism of I/R injury is not critically dependent on P-selectin.
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- 2002
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36. A COMPREHENSIVE GERIATRIC INTERVENTION REDUCES SHORT- AND LONG-TERM MORTALITY IN OLDER PEOPLE WITH HIP FRACTURE
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Ernesto Palummeri, Andrea Giusti, Monica Razzano, Giulio Pioli, Monica Pizzonia, and Antonella Barone
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Geriatrics ,Gerontology ,medicine.medical_specialty ,Hip fracture ,Patient care team ,business.industry ,Hospital mortality ,medicine.disease ,Intervention (counseling) ,medicine ,Physical therapy ,Long term mortality ,Geriatrics and Gerontology ,business ,Older people - Published
- 2006
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37. Vitamin D increases circulating IGF1 in adults: potential implication for the treatment of GH deficiency
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Giovanna Leoncini, Mara Boschetti, Claudia Teti, Diego Ferone, Giovanni Murialdo, Andrea Giusti, Francesco Minuto, Marta Bovio, and Pietro Ameri
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Vitamin ,Male ,medicine.medical_specialty ,medicine.drug_class ,Hormone Replacement Therapy ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,vitamin D deficiency ,Medical Records ,chemistry.chemical_compound ,Endocrinology ,Internal medicine ,medicine ,Vitamin D and neurology ,Humans ,Prospective Studies ,Insulin-Like Growth Factor I ,Vitamin D ,Prospective cohort study ,Testosterone ,Aged ,Retrospective Studies ,business.industry ,Human Growth Hormone ,Thyroid ,Hormone replacement therapy (menopause) ,General Medicine ,Vitamins ,Middle Aged ,medicine.disease ,Vitamin D Deficiency ,medicine.anatomical_structure ,Logistic Models ,Treatment Outcome ,chemistry ,Italy ,Estrogen ,Linear Models ,Female ,business - Abstract
ObjectivesPrevious studies suggested that vitamin D modulates circulating IGF1. We investigated this effect in adults and its clinical relevance in the management of GH deficiency (GHD).Design and methodsIGF1 levels were prospectively measured before and after 12 weeks of treatment with oral vitamin D3(5000 or 7000 IU/week) vs no intervention in 39 subjects 61.9±7.9 years old. The frequency of IGF1 values ≥50th age- and sex-specific percentile in relation to vitamin D status, as determined by the concentration of 25-hydroxyvitamin D (25(OH)D), was retrospectively assessed in 69 GHD patients (57.4±16.6 years) on stable hormone replacement and with 25(OH)D and IGF1 concurrently measured.ResultsTreatment with 5000 and 7000 IU vitamin D3/week significantly raised 25(OH)D by 12.7±8.4 and 13.1±6.5 ng/ml respectively (bothPP=0.01). Neither 25(OH)D nor IGF1 significantly varied in controls. IGF1 was ≥50th percentile more frequently in GHD patients with 25(OH)D levels ≥15 than PPβ−0.042,Pβ−0.037,P=0.06).ConclusionsVitamin D increases circulating IGF1 in adults. As a result, a better vitamin D status may ease the achievement of normal IGF1 values in GHD.
- Published
- 2013
38. Bisphosphonates in the management of thalassemia-associated osteoporosis: a systematic review of randomised controlled trials
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Andrea Giusti
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medicine.medical_specialty ,PubMed ,Endocrinology, Diabetes and Metabolism ,Osteoporosis ,Management of thalassemia ,Bone resorption ,Bone remodeling ,Endocrinology ,Internal medicine ,medicine ,Back pain ,Animals ,Humans ,Orthopedics and Sports Medicine ,Bone pain ,Randomized Controlled Trials as Topic ,Diphosphonates ,business.industry ,beta-Thalassemia ,General Medicine ,medicine.disease ,Zoledronic acid ,Tolerability ,Physical therapy ,medicine.symptom ,business ,medicine.drug - Abstract
Bisphosphonates are potent inhibitors of bone resorption, widely used for the management of osteoporosis and fracture prevention. Recent evidence suggests that bisphosphonates may have beneficial effects in the treatment of thalassemia-associated osteoporosis, a complex and multifactorial condition. Here we summarise available data about the efficacy and tolerability of bisphosphonates in beta--thalassemic patients. Randomised controlled trials (RCTs) of bisphosphonates in beta-thalassemia were identified searching PubMed. Studies were reviewed to retrieve relevant clinical information. The following variables were considered to assess the safety and efficacy of bisphosphonates-bone mineral density (BMD), markers of bone turnover, incidence of fragility fracture, bone pain, back pain, and clinical adverse events. Five RCTs were identified, investigating alendronate, clodronate, zoledronic acid and neridronate. All bisphosphonates produced a significant decrease of the markers of bone turnover. Alendronate, neridronate, and zoledronic acid significantly improved BMD at the lumbar spine, femoral neck and total hip. Zoledronic acid and neridronate were also shown to reduce bone and back pain. Probably due to the small sample sizes and to the short duration of the trials, it was not possible to establish the anti-fracture efficacy of bisphosphonates; however, they were well tolerated and adverse events were rare but expected on the basis of previous studies. Sufficient evidence exists to support the use of bisphosphonates in the management of thalassemia-associated osteoporosis (to prevent bone loss and improve the BMD). Further research is warranted to establish their anti-fracture efficacy and long-term safety.
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- 2013
39. Low-energy fractures of the humeral shaft and bisphosphonate use
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Neveen A. T. Hamdy, Sharita R. Ramautar, Maria P. Yavropoulou, P. D. Sander Dijkstra, Andrea Giusti, and Socrates E. Papapoulos
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Male ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Radiography ,medicine.medical_treatment ,Dentistry ,ATYPICAL ,Single Center ,BISPHOSPHONATES ,medicine ,Humans ,Orthopedics and Sports Medicine ,Humerus ,Femur ,HUMERAL FRACTURES ,GLUCOCORTICOIDS ,Aged ,Demography ,Netherlands ,Diphosphonates ,business.industry ,Odds ratio ,Middle Aged ,Bisphosphonate ,Confidence interval ,Surgery ,medicine.anatomical_structure ,Humeral shaft ,Female ,business ,CORTICAL THICKNESS - Abstract
Atypical fractures of the femur have been reported to occur in patients on long-term treatment with bisphosphonates; however, causality has not been proven, and it is not known whether similar fractures may occur in other long bones. We addressed this issue by examining the relationship between humeral shaft fractures and bisphosphonate use. We identified all patients aged ≥50 years consecutively admitted to a single center with a new fracture of the humerus. All individual radiographs were examined and fracture site was classified. A case-control study was undertaken in patients with humeral shaft fractures, and controls were sex- and age-matched patients with proximal humeral fractures in a 1:4 ratio. Patients with shaft fractures and radiographic characteristics similar to those of atypical femoral fractures were compared with those with ordinary shaft fractures. The association between “atypical” fractures and bisphosphonate or glucocorticoid use was examined. A total of 198 patients had a low-energy fracture of the humerus; 20 of these patients had a shaft fracture (10%). These 20 patients (cases) were matched with 80 patients with proximal fractures (controls). Bisphosphonates were used by 5% of cases and by 6.3% of controls (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.09–6.85); glucocorticoids were used by 10% of cases and 8.8% of controls (OR, 1.15; 95% CI, 0.23–5.83). There was no difference in cortical thickness between cases and controls and bisphosphonate or glucocorticoid users and nonusers. Four of the 20 patients with shaft fractures had “atypical” radiographic features, with significantly increased cortical thickness, but none of these had ever been treated with bisphosphonates or glucocorticoids. Our results show that low-energy fractures of the humeral shaft with “atypical” radiographic characteristics are infrequent and are not associated with the use of bisphosphonates or glucocorticoids. © 2012 American Society for Bone and Mineral Research.
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- 2012
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40. Challenges in the differential diagnosis of hypercalcemia: A case of hypercalcemia with normal PTH level
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Andrea Giusti, Alberto Ferrari, Giulio Pioli, Francesca Pellicciotti, Maria Carolina Gelli, and Salvatore Foderaro
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medicine.medical_specialty ,Heterogeneous group ,endocrine system diseases ,business.industry ,medicine.medical_treatment ,Parathyroid hormone ,chemistry.chemical_element ,Case Report ,Bisphosphonate ,Calcium ,medicine.disease ,Normal pth ,Endocrinology ,Oncology ,chemistry ,Internal medicine ,medicine ,Differential diagnosis ,business ,Bisphosphonate treatment ,Primary hyperparathyroidism ,hormones, hormone substitutes, and hormone antagonists - Abstract
The hypercalcemias are a common and heterogeneous group of disorders, ranging from the occasional detection of a high level of serum calcium to a life-treating condition. In a patient presenting with hypercalcemia, a differential diagnosis can be established easily by measuring serum calcium and parathyroid hormone (PTH) concentrations. We describe the case of an 83-year-old man presenting with a severe symptomatic hypercalcemia with high-normal PTH level due to the coexistence of primary hyperparathyroidism and malignancy-associated hypercalcemia. The presence of two conditions producing hypercalcemia was revealed only during in-hospital stay and after the administration of an intravenous bisphosphonate, when the PTH concentration increased rapidly after bisphosphonate treatment with a decrease in serum calcium. The occurrence of two conditions producing hypercalcemia is a rare event in the literature, and should be considered in the presence of an abnormally high serum calcium level associated with normal or high-normal PTH, in order to establish a correct diagnosis and appropriate interventions.
- Published
- 2012
41. Uses and misuses of statistics: the case of strontium ranelate and the number needed to treat
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Giulio Pioli, Andrea Giusti, and Mario Pedrazzoni
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Relative risk reduction ,medicine.medical_specialty ,Drug Industry ,Endocrinology, Diabetes and Metabolism ,Alternative medicine ,Thiophenes ,law.invention ,Competition (economics) ,Fractures, Bone ,Endocrinology ,Randomized controlled trial ,law ,medicine ,Organometallic Compounds ,Humans ,Intensive care medicine ,Randomized Controlled Trials as Topic ,Bone Density Conservation Agents ,business.industry ,Absolute risk reduction ,A share ,Surgery ,Number needed to treat ,Osteoporosis ,Observational study ,business ,Numbers Needed To Treat - Abstract
In the last 15 years, several pharmacological agents for the prevention of fractures have been developed and commercialized. Most of them showed to be effective in reducing fracture risk. The enhanced availability of drugs to prevent fractures has generated a fierce competition among pharmaceutical companies to conquer a share of the potential market, often with claims of superiority of a drug over another without direct comparisons. The definitive way to compare different treatments would require randomized head to head trials. These trials are expensive, need large samples and are unlikely to be ever performed. Therefore, it has become a common practice to compare pharmacological agents through observational studies on administrative databases or by the indirect comparison of the results of individual randomised-controlled trials (RCT) and their meta-analyses. These studies may produce evidence of clinical value, complementary to that given by RCT. However, without a proper and complete analysis, they may result in a biased picture of effectiveness and be completely misleading. In this article, we critically disclose how such competition may produce biased and misleading picture of evidence, by reviewing the significance of the number needed to treat, absolute risk reduction and relative risk reduction in relation to vertebral fractures prevention with available drugs.
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- 2011
42. Guidelines on prevention and treatment of vitamin D deficiency
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Silvano Adami, Vincenzo Carnevale, Davide Gatti, Salvatore Minisola, Maurizio Rossini, Andrea Giusti, Elisabetta Romagnoli, Alfredo Scillitani, and R. Nuti
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lcsh:Internal medicine ,medicine.medical_specialty ,Pregnancy ,Maintenance dose ,Cumulative dose ,business.industry ,lcsh:R ,Osteoporosis ,lcsh:Medicine ,Physiology ,medicine.disease ,vitamin D deficiency ,Endocrinology ,Rheumatology ,Internal medicine ,medicine ,Vitamin D and neurology ,Mineral metabolism ,lcsh:RC31-1245 ,business ,Primary hyperparathyroidism - Abstract
The Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) has elaborated the following guidelines about the definition, prevention and treatment of inadequate vitamin D status. The highlights are presented here. Daily vitamin D allowance ranges from 1,500 IU (healthy adults) to 2,300 IU (elderly with low calcium intake). Since the average Italian diet includes around 300 IU/day, subjects with no effective sun exposure should be supplemented with 1,200-2,000 IU vitamin D per day. The serum 25-hydroxy-vitamin D [25(OH)D] levels represents the most accurate way to assess vitamin D repletion, even though there are still no standardized assay methods. Conditions of “deficiency” and “insufficiency” are defined by the following ranges of 25(OH)D levels: less than 20 ng/ml and 20-30 ng/ml, respectively. In Italy, approximately 50% of young healthy subjects have vitamin D insufficiency during the winter months. The prevalence of deficiency increases with ageing, affecting almost all elderly subjects not on vitamin D supplements. When a condition of deficiency has been identified, a cumulative dose of 300,000-1,000,000 IU, over 1-4 weeks is recommended. In subjects recently treated for deficiency-insufficiency, a maintenance dose of 800-2,000 IU/day (or weekly equivalent) is recommended. In patients on daily doses over 1,000 IU, 25(OH)D levels should be checked regularly (e.g. once every two years). The highest tolerated daily dose has been identified as 4,000 IU/day. Vitamin D supplementation should be carefully monitored in patients at higher risk of vitamin D intoxication (granulomatosis) or with primary hyperparathyroidism. In pregnant women, vitamin D supplements should be given as in non-pregnant women, but bolus administration (i.e.: single dose >25,000 IU) should be avoided.
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- 2011
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43. Atypical fractures and bisphosphonate therapy: A cohort study of patients with femoral fracture with radiographic adjudication of fracture site and features
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Andrea Giusti, P. D. Sander Dijkstra, Socrates E. Papapoulos, Olaf M. Dekkers, Sharita R. Ramautar, and Neveen A. T. Hamdy
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Male ,medicine.medical_specialty ,Histology ,Atypical femoral fractures ,Subtrochanteric fractures ,Physiology ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Radiography ,Fracture site ,Single Center ,Cortical thickness ,Cohort Studies ,medicine ,Humans ,Glucocorticoids ,Aged ,Aged, 80 and over ,Hip fracture ,Diphosphonates ,business.industry ,Hip Fractures ,Case-control study ,Femoral fracture ,Bisphosphonates ,Bisphosphonate ,Middle Aged ,medicine.disease ,Surgery ,Case-Control Studies ,Female ,business ,Femoral Fractures ,Cohort study - Abstract
Atypical subtrochanteric/femoral shaft (ST/FS) fractures are increasingly reported in patients on long-term treatment with bisphosphonates (BPs). We estimated the frequency of atypical fractures and their association to BP use in patients aged ≥ 50 years consecutively admitted to a single center with a new femoral fracture. All individual radiographs were examined and fracture site confirmed. A case-control study of patients with low-energy ST/FS fractures, age- and sex-matched with patients with hip fractures (1:2 ratio), was performed. Patients with atypical ST/FS fractures were further compared with those with ordinary ST/FS fractures. Cortical thickness (CT) was measured in radiographs of cases and controls. Ninety-six of 906 patients (10.6%) had a ST/FS fracture. Of these, 63 with low-energy fractures were individually matched with 126 controls with hip fracture. BPs were used by 9.5% of cases and by 8.7% of controls (OR, 1.10; 95% CI, 0.39-3.06) with comparable duration of therapy between groups (54 ± 35 vs. 54 ± 52 months, P=0.53). CT was comparable between cases and controls, BP users and non-users, and was not related to treatment duration. Atypical fractures were observed in 10/63 ST/FS cases (15.9%). Compared to patients with ordinary ST/FS fractures, those with atypical fractures were using more frequently BPs (OR, 17.0; 95% CI, 2.6-113.3) and glucocorticoids (OR, 5.3; 95% CI, 0.9-28.6). Among patients with atypical fractures, CT was comparable between BP users and non-users. In conclusion, atypical femoral fractures have a low prevalence (1.1% of all femoral fractures), compared to ordinary ST/FS fractures are more frequent in bisphosphonate users, but equally occur in patients never treated with bisphosphonates.
- Published
- 2011
44. Effect of Repeated Application of Low-Intensity Pulsed Electromagnetic Fields (PEMF) on Gait Speed in Older Adults with a History of Falls
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Francesco Fratoni, Gerolamo Bianchi, Armando De Vincentiis, Andrea Giusti, and Massimo Giovale
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Male ,Electromagnetic field ,medicine.medical_specialty ,Time Factors ,Injury control ,business.industry ,Accident prevention ,Magnetic Field Therapy ,Poison control ,Intensity (physics) ,Gait speed ,Physical medicine and rehabilitation ,Physical therapy ,Humans ,Medicine ,Accidental Falls ,Female ,Geriatrics and Gerontology ,business ,Gait ,Aged ,Retrospective Studies - Published
- 2014
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45. Heterogeneity in serum 25-hydroxy-vitamin D response to cholecalciferol in elderly women with secondary hyperparathyroidism and vitamin D deficiency
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Antonella Barone, Gerolamo Bianchi, Giulio Pioli, Andrea Giusti, Monica Razzano, Mario Pedrazzoni, G. Girasole, E. Palummeri, and Monica Pizzonia
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medicine.medical_specialty ,Histology ,Physiology ,Endocrinology, Diabetes and Metabolism ,vitamin D deficiency ,Collagen Type I ,Phosphates ,chemistry.chemical_compound ,Internal medicine ,medicine ,Vitamin D and neurology ,Humans ,Vitamin D ,Aged ,Cholecalciferol ,Dose-Response Relationship, Drug ,business.industry ,Vitamins ,medicine.disease ,Alkaline Phosphatase ,Vitamin D Deficiency ,Endocrinology ,chemistry ,Parathyroid Hormone ,Secondary hyperparathyroidism ,Calcium ,Female ,Hyperparathyroidism, Secondary ,business ,Peptides ,Biomarkers - Abstract
To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol.Randomized-controlled trial with 6-month follow-up.Two osteoporosis centers in northern Italy.Sixty community-dwelling women aged 65 and older with sHPTH and hypovitaminosis D, creatinine clearance greater than 65 mL/min and without diseases or drugs known to influence bone and vitamin D metabolism.Cholecalciferol 300,000 IU every 3 months, once at baseline and once at 3 months (intermittent D(3) group) or cholecalciferol 1,000 IU/day (daily D(3) group).Serum PTH, 25(OH)D, calcium, bone-specific alkaline phosphatase, β-C-terminal telopeptide of type I collagen, phosphate, 24-hour urinary calcium excretion.The two groups had similar baseline characteristics. All participants had vitamin D deficiency [25(OH)D20 ng/mL)], and 36 subjects (60%) had severe deficiency (10 ng/mL), with no difference between the groups (severe deficiency: intermittent D(3) group, n=18; daily D(3) group, n=18). After 3 and 6 months, both groups had a significant increase in 25(OH)D and a reduction in PTH. Mean absolute increase ± standard deviation of 25(OH)D at 6 months was higher in the intermittent D(3) group (22.7±11.8 ng/mL) than in the daily D(3) group (13.7±6.7 ng/mL, P.001), with a higher proportion of participants in the intermittent D(3) group reaching desirable serum concentration of 25(OH)D≥30 ng/mL (55% in the intermittent D(3) group vs 20% in the daily D(3) group, P.001). Mean percentage decrease of PTH in the two groups was comparable, and at 6 months, a similar proportion of participants reached normal PTH values. 25(OH)D response to cholecalciferol showed a wide variability. In a logistic regression analysis, body mass index and type of treatment appeared to be significantly associated with normalization of 25(OH)D values.Cholecalciferol 300,000 IU every 3 months was more effective than 1,000 IU daily in correcting vitamin D deficiency, although the two groups achieved similar effects on PTH at 6 months. Only 55% of the higher-dose intermittent group reached desirable concentrations of 25(OH)D, suggesting that yet-higher doses will be required for adequate vitamin D repletion.
- Published
- 2010
46. Bisphosphonates in the Management of Idiopathic Hypercalciuria Associated with Osteoporosis: A New Trick from an Old Drug
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G. Girasole, Ernesto Palummeri, Gerolamo Bianchi, Antonella Barone, Andrea Giusti, and Giulio Pioli
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medicine.medical_specialty ,business.industry ,Osteoporosis ,Review ,medicine.disease ,Bone tissue ,Urinary calcium ,Bone resorption ,Bone remodeling ,Pathogenesis ,Endocrinology ,medicine.anatomical_structure ,Rheumatology ,Internal medicine ,medicine ,Orthopedics and Sports Medicine ,Hypercalciuria ,business ,Primary hyperparathyroidism - Abstract
Idiopathic hypercalciuria (IHC) is defined as a 24-hour urinary calcium excretion that exceeds 4 mg/kg/day, regardless of gender and in absence of systemic diseases or pharmacological treatments that may cause normocalcemic hypercalciuria (eg sarcoidosis, normocalcemic primary hyperparathyroidism, vitamin D intoxication, hyperthyroidism). Patients with IHC and nephrolithiasis often present increased bone turnover, decreased bone mineral density (BMD) and increased susceptibility to fragility fractures. Although the pathogenesis of IHC seems complex and multifactorial, recent evidences suggest that cells involved in bone resorption may play a critical role in the chain of events leading to the excessive urinary calcium excretion. Therefore, it has been proposed that bisphosphonates, potent inhibitors of bone resorption, may have beneficial effects in hypercalciuric patients with low BMD. This manuscript reports recent findings regarding the role of bone tissue in the pathogenesis of IHC, and supports the use of bisphosphonates in such conditions. It also reviews the literature on the effects of bisphosphonates in subjects with osteoporosis-associated IHC.
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- 2010
47. Treatment of Male Osteoporosis with Bisphosphonates
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Andrea Giusti and Socrates E. Papapoulos
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Bone mineral ,Gynecology ,medicine.medical_specialty ,Pharmacological therapy ,business.industry ,Osteoporosis ,Postmenopausal osteoporosis ,urologic and male genital diseases ,medicine.disease ,Bone resorption ,Internal medicine ,medicine ,business ,hormones, hormone substitutes, and hormone antagonists - Abstract
Publisher Summary Bisphosphonates (BPs) are widely used in the treatment of postmenopausal osteoporosis. They decrease the rate of bone resorption and turnover, they increase bone mineral density (BMD), they preserve or improve structural and material properties of bone and thereby decrease the risk of fractures. In contrast to the wealth of data of the efficacy of BPs in the management of postmenopausal osteoporosis, information regarding their efficacy in male osteoporosis is relatively limited. However, a number of studies help to position BPs in the pharmacological therapy of male osteoporosis. In assessing available evidence, two main questions need to be answered. First, do men respond differently from women to BPs? Second, is there any direct evidence for their efficacy in men with osteoporosis? This chapter addresses these questions and reviews the data supporting the use of BPs in the management of male osteoporosis.
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- 2010
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48. Factors associated with an immediate weight-bearing and early ambulation program for older adults after hip fracture repair
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Ernesto Palummeri, Antonella Barone, Giulio Pioli, Mauro Oliveri, Monica Pizzonia, Andrea Giusti, and Monica Razzano
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medicine.medical_specialty ,Time Factors ,Physical Therapy, Sports Therapy and Rehabilitation ,law.invention ,Ambulation training ,Randomized controlled trial ,law ,Acute care ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Early Ambulation ,Aged ,Aged, 80 and over ,Hip fracture ,business.industry ,Hip Fractures ,Rehabilitation ,Resistance Training ,Odds ratio ,medicine.disease ,Comorbidity ,Orthopedic surgery ,Physical therapy ,business - Abstract
Barone A, Giusti A, Pizzonia M, Razzano M, Oliveri M, Palummeri E, Pioli G. Factors associated with an immediate weight-bearing and early ambulation program for older adults after hip fracture repair. Objective To evaluate baseline characteristics and in-hospital factors associated with nonadherence with an immediate weight-bearing and early ambulation (IWB-EA) program after hip fracture (HF) surgery. Design Prospective inception cohort study. Setting Ortho-geriatric unit in an acute care hospital. Participants Older adults (N=469) admitted with an osteoporotic HF who underwent surgery. Interventions Immediate weight-bearing and assisted ambulation training on the first postoperative day (all patients). Main Outcome Measure Proportion of subjects who adhered to the IWB-EA protocol within 48 hours of surgery. Results A total of 366 patients (78%) bore weight and ambulated within 48 hours (weight-bearing [WB] group) while the others did not adhere to the protocol (nonweight-bearing [NWB] group). Subjects in the NWB group were significantly older, were more cognitively and functionally impaired, and presented a higher comorbidity at baseline. A higher proportion of subjects in the NWB group (42.7%) than the WB group (23.5%; P Conclusions This study establishes that IWB-EA is feasible in a high proportion of patients after surgical stabilization of HF. Neither cognitive impairment nor high comorbidity influenced significantly the adherence to the protocol, indicating that IWB-EA may be offered to an unselected population of the elderly with HF. The day of surgery (eg, preholiday or not) was the only variable influencing the participation to the IWB-EA protocol, suggesting the importance of maintaining the same standard of daytime care every day of the week.
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- 2009
49. Predictors of hospital readmission in a cohort of 236 elderly discharged after surgical repair of hip fracture: one-year follow-up
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Monica Pizzonia, Antonella Barone, Giulio Pioli, Mauro Oliveri, Andrea Giusti, and Monica Razzano
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Male ,Aging ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Patient Readmission ,Cohort Studies ,medicine ,Humans ,Prospective cohort study ,Surgical repair ,Aged, 80 and over ,Hip fracture ,Rehabilitation ,business.industry ,Hip Fractures ,medicine.disease ,Comorbidity ,Patient Discharge ,Emergency medicine ,Cohort ,Orthopedic surgery ,Physical therapy ,Female ,Geriatrics and Gerontology ,business ,Cohort study ,Follow-Up Studies - Abstract
Background and aims: Few studies have investigated predictors for hospital readmission after hip fracture repair. Methods: In a prospective cohort study we evaluated factors associated with early (within 3 months) and late (between 3–12 months), single and multiple hospital readmission in 236 hip-fractured older adults admitted to an orthopedic unit. Baseline patient characteristics and hospital course (functional and cognitive status, comorbidity, type of fracture, time to surgery, in-hospital stay, complications) were recorded. Hospital readmission over 12 months and ICD-9 principal diagnosis were ascertained from administrative sources. Functional status at the end of the rehabilitation program was assessed by telephone interviews. Results: Seventy-one patients (30.1%) were readmitted to hospital within twelve months of discharge and 22 (9.3%) had two or more readmission. The total number of readmissions was 105, 43 (41%) occurred in the first three months. The most common readmission causes were cardiac, infectious and cerebrovascular; surgical complication accounted for 5.7%. Patients with a single readmission, like those with multiple readmissions, were sicker (CIRS-CIsubscore 4.0±1.8 vs 3.2±1.6, p=0.010) and more functionally impaired at the end of rehabilitation (2 months’ Katz index 2.1±2 vs 2.9±2.3, p=0.007) than controls. In a multiple logistic regression model, comorbidity and functional status at the end of rehabilitation were the only factors associated with the risk of readmission. Conclusions: Subjects at high risk of readmission can be reliably assessed, since few significant variables were associated with rehospitalization. Subgroups of patients with an elevated risk of rehospitalization after hip fracture may be the target for strategies to reduce the burden of excessive hospital use and improve overall outcomes.
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- 2008
50. Orthogeriatric care for the elderly with hip fractures: where are we?
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Antonella Barone, Andrea Giusti, and Giulio Pioli
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Aging ,medicine.medical_specialty ,Health Services for the Aged ,Center of excellence ,medicine.medical_treatment ,Frail Elderly ,Population ,Multidisciplinary approach ,Health care ,medicine ,Humans ,Intensive care medicine ,education ,Aged ,Hip fracture ,education.field_of_study ,Rehabilitation ,business.industry ,Hip Fractures ,medicine.disease ,Integrated care ,Orthopedics ,Italy ,Physical therapy ,Delirium ,Geriatrics and Gerontology ,medicine.symptom ,business ,Hospital Units - Abstract
Hip fracture (HF) is a major health care problem in the Western world, associated with significant morbidity, mortality and loss of function. Its incidence is expected to increase as the population ages. The authors discuss the role of a coordinated multidisciplinary team in the management of patients during hospital stay, at discharge and during rehabilitation. Orthogeriatric care should not just be viewed as a multidisciplinary activity, but as a radical alternative to the traditional model of care, an alternative based on all those strategies in which evidence shows an improvement in outcomes in the fractured elderly. Therefore, key points of the care are early surgery, immediate mobilization, prevention and management of delirium, pain and malnutrition, as well as an integrated and multidisciplinary approach. Comprehensive geriatric assessment is useful in identifying frail elderly and in providing information that is essential in formulating clinical recommendations and making care plans. In each hospital, the orthogeriatric unit should represent a center of excellence for treating elderly patients with major fractures. However, when an orthogeriatric project is implemented, it is essential that detailed data about the case-mix of patients, process of care and outcomes are collected, to compare the results with historical data and to be able to participate in audit processes.
- Published
- 2008
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