22 results on '"Thomasius, F."'
Search Results
2. Clinical Practice Guideline: The Diagnosis and Treatment of Osteoporosis.
- Author
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Thomasius F, Kurth A, Baum E, Drey M, Maus U, and Schmidmaier R
- Abstract
Background: Osteoporosis is a common disease that affects approximately 6 million people in Germany alone. Osteoporotic fractures impair the quality of life and may make independent living impossible. Recommendations on the diagnosis and treatment of osteoporosis are indispensable for the effective care of this large group of patients., Methods: For a thorough updating of the German clinical practice guideline (an evidence-based guideline with recommendations for clinical practice) on osteoporosis, a comprehensive, systematic search for relevant publications was carried out, including guidelines from other countries. The retrieved literature was assessed with standardized (Oxford) criteria, and clinically relevant key questions were answered according to the PICO scheme ("population, intervention, comparison, outcomes")., Results: The assessment of clinical risk factors for osteoporosis is the basis of osteoporosis diagnostics, which should be carried out quickly after a fracture. If risk factors are present in a postmenopausal woman or a man aged 50 or above, bone densitometry testing with dual-energy x-ray absorptiometry (DXA) is recommended. The further diagnostic evaluation should proceed in stepwise fashion depending on the clinical symptoms, the fracture status, and the degree of bone density reduction. Pharmacotherapy should be adapted to the fracture risk. Osteoanabolic treatment is recommended with high priority if the patient is judged to have a very high risk of fracture (10% or more in the next three years). The further course and duration of treatment should be determined individually, depending on the evolution of the patient's clinical state., Conclusion: Prerequisites for the optimal treatment of patients with osteoporosis include a correct diagnosis and interdisciplinary and interprofessional collaboration to determine and provide the proper treatment. 71% of persons with osteoporosis in Germany are still untreated, and this gap must be closed.
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- 2025
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3. Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER ® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk.
- Author
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Hadji P, Kamali L, Thomasius F, Horas K, Kurth A, and Bock N
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- Humans, Female, Aged, Retrospective Studies, Middle Aged, Femur Neck physiopathology, Aged, 80 and over, Treatment Outcome, Imaging, Three-Dimensional methods, Teriparatide therapeutic use, Teriparatide pharmacology, Teriparatide administration & dosage, Bone Density Conservation Agents therapeutic use, Bone Density Conservation Agents pharmacology, Bone Density Conservation Agents administration & dosage, Bone Density drug effects, Biosimilar Pharmaceuticals therapeutic use, Biosimilar Pharmaceuticals pharmacology, Biosimilar Pharmaceuticals administration & dosage, Osteoporotic Fractures prevention & control, Osteoporotic Fractures diagnostic imaging, Osteoporotic Fractures physiopathology, Osteoporosis, Postmenopausal drug therapy, Osteoporosis, Postmenopausal physiopathology, Osteoporosis, Postmenopausal diagnostic imaging, Cancellous Bone drug effects, Cancellous Bone diagnostic imaging, Cancellous Bone physiopathology, Absorptiometry, Photon methods, Lumbar Vertebrae physiopathology, Lumbar Vertebrae diagnostic imaging, Tomography, X-Ray Computed methods, Ultrasonography methods
- Abstract
A retrospective analysis comparing a teriparatide biosimilar (RGB-10) with reference teriparatide for osteoporosis treatment in postmenopausal women at high fracture risk found them to be therapeutically equivalent. Both provided significant improvements in lumber spine BMD, TBS, and other parameters of bone health, assessed using multiple diagnostic methods., Purpose: To compare the therapeutic efficacy of a teriparatide biosimilar (RGB-10) with reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high fracture risk., Methods: A retrospective analysis of 25 postmenopausal female patients treated for osteoporosis with RGB-10 for 24 months and a matched cohort of 25 patients treated with reference teriparatide. The following outcomes were assessed at baseline, 12 and 24 months: bone mineral density (BMD) at the lumbar spine, femoral neck and total hip using dual-energy x-ray absorptiometry (DXA) and integral, trabecular and cortical volumetric and surface BMD using 3D-SHAPER
® imaging, trabecular bone score (TBS), quantitative ultrasound (QUS) measurements, and high-resolution peripheral quantitative computed tomography (HRpQCT) imaging of the radius and tibia., Results: No significant differences were observed between treatment groups in any of the measured parameters of BMD or bone health at baseline as well as in any timepoint when assessed using these various diagnostic methods. Both compounds provided equivalent significant improvements from baseline in measures of osteoporosis and fracture risk., Conclusion: The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture., Competing Interests: Declarations. Ethics approval and consent to participate: This study was performed in accordance with the Declaration of Helsinki as well as with local ethical requirements. All study subjects gave written consent to participate. Conflicts of interest: P. Hadji: Has received study, educational and travel support from Amgen, Elli Lilly, Gedeon Richter, STADA Arzneimittel AG, Theramex and UCB. L. Kamali: No conflicts of interest relevant to this work. F. Thomasius: Has received honoraria for consulting or lectures from Amgen, Fresenius, Gedeon-Richter, STADA Arzneimittel AG, Theramex and UCB. K. Horas: No conflicts of interest relevant to this work. A. Kurth: Has received fees as a scientific advisor for Amgen, Theramex, Merit Medical, AgNovos, UCB, Image Biopsie Lab and as a lecturer for Amgen, STADA Arzneimittel AG, UCB, Alexion, AgNovos, Hologic. N. Bock: No conflicts of interest relevant to this work., (© 2024. The Author(s).)- Published
- 2024
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4. [The current guideline for osteoporosis: aspects of treating older patients].
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Drey M, Otto S, Thomasius F, and Schmidmaier R
- Published
- 2024
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5. Goal-directed osteoporosis treatment: ASBMR/BHOF task force position statement 2024.
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Cosman F, Lewiecki EM, Eastell R, Ebeling PR, Jan De Beur S, Langdahl B, Rhee Y, Fuleihan GE, Kiel DP, Schousboe JT, Borges JL, Cheung AM, Diez-Perez A, Hadji P, Tanaka S, Thomasius F, Xia W, and Cummings SR
- Subjects
- Humans, Goals, Osteoporotic Fractures prevention & control, Female, Advisory Committees, Risk Factors, Bone Density Conservation Agents therapeutic use, Osteoporosis drug therapy, Bone Density drug effects
- Abstract
The overarching goal of osteoporosis management is to prevent fractures. A goal-directed approach to long-term management of fracture risk helps ensure that the most appropriate initial treatment and treatment sequence is selected for individual patients. Goal-directed treatment decisions require assessment of clinical fracture history, vertebral fracture identification (using vertebral imaging as appropriate), measurement of bone mineral density (BMD), and consideration of other major clinical risk factors. Treatment targets should be tailored to each patient's individual risk profile and based on the specific indication for beginning treatment, including recency, site, number and severity of prior fractures, and BMD levels at the total hip, femoral neck, and lumbar spine. Instead of first-line bisphosphonate treatment for all patients, selection of initial treatment should focus on reducing fracture risk rapidly for patients at very high and imminent risk, such as in those with recent fractures. Initial treatment selection should also consider the probability that a BMD treatment target can be attained within a reasonable period of time and the differential magnitude of fracture risk reduction and BMD impact with osteoanabolic versus antiresorptive therapy. This position statement of the ASBMR/BHOF Task Force on Goal-Directed Osteoporosis Treatment provides an overall summary of the major clinical recommendations about treatment targets and strategies to achieve those targets based on the best evidence available, derived primarily from studies in older postmenopausal women of European ancestry., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)
- Published
- 2024
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6. [Update of the S3-guideline on diagnostics, prophylaxis and treatment of osteoporosis].
- Author
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Drey M, Otto S, Thomasius F, and Schmidmaier R
- Subjects
- Humans, Aged, Female, Male, Osteoporosis diagnosis, Osteoporosis prevention & control, Osteoporosis drug therapy, Bone Density Conservation Agents therapeutic use, Bone Density Conservation Agents adverse effects, Osteoporotic Fractures prevention & control, Osteoporotic Fractures diagnosis, Practice Guidelines as Topic
- Abstract
With the aid of a new fracture risk model, the great treatment gap for osteoporosis should be closed. All patients older than 70 years should undergo a diagnostic procedure for osteoporosis. An additional risk threshold (≥ 10% per 3 years for femoral and vertebral fractures) should enable patients with a high risk of fracture to be treated with osteoanabolic agents. The use of osteoanabolic agents makes it necessary to administer antiresorptive drugs afterwards. Due to the low event rate of osteonecrosis of the jaw, the initiation of a specific osteoporosis treatment should not be delayed by prophylactic dental treatment. The adherence to the drug treatment should be improved by an individualized approach on the basis of a cooperation between patients, caregivers, and physicians. A regular assessment of falls, including the timed up and go test should be carried out in patients older than 70 years., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
- Published
- 2024
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7. [Osteoporosis - implications of the new guidelines in practice].
- Author
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Siggelkow H and Thomasius F
- Subjects
- Humans, Female, Male, Middle Aged, Risk Factors, Aged, Risk Assessment, Osteoporotic Fractures prevention & control, Bone Density Conservation Agents therapeutic use, Osteoporosis therapy, Osteoporosis diagnosis, Osteoporosis drug therapy, Practice Guidelines as Topic, Bone Density
- Abstract
In September 2023, the guideline on the prophylaxis, diagnosis, and treatment of osteoporosis in postmenopausal women and men was published as a completely revised guideline. The implications for practice include a change in the justifying indication for performing a bone density measurement, the time interval over which the fracture risk is determined, the level and number of therapy thresholds, and the recommendations for the therapeutic approach that are adapted to the individual fracture risk present. Risk assessment for the prediction of spine and hip fractures is essential in the context of osteoporosis diagnostics. In addition to age and gender, there are a total of 33 risk factors to determine the individual risk of fracture. Much more attention is paid to the assessment of the risk of falls and, depending on the result, combined with recommendations for muscle training and protein intake from the age of 65. Risk indicators must also be taken into account when determining the indication for osteoporosis diagnosis, as well as the risk factors of the imminent risk of fracture. The indication for baseline diagnostics has changed from the >20% 10-year fracture risk to diagnostics in postmenopausal women and in men aged 50 years and older, depending on the fracture risk factor profile. This eliminates a specific fracture risk threshold for basic diagnostics. Thus, in the young patient group (50-60 years), the risk factors considered medically relevant for the indication for osteoporosis diagnosis must be taken into account. New thresholds as an indication for initiating therapy is the determination of fracture risk using a risk calculator over 3 years instead of 10 years. The indication for drug therapy should be based on the threshold values of the DVO risk model. The data clearly suggests a significantly faster and more effective fracture risk-reducing effect of anabolic therapy. This is recommended in the first sequence in cases of a very high risk of fracture from 10%/3 years with osteoanabolic active substances (teriparatide or romosozumab). Such a therapy sequence should be initiated directly and not delayed due to upcoming dental procedures. Follow-up therapy to consolidate the reduction of fracture risk should be chosen individually., Competing Interests: Dr. Friederike Thomasius gibt folgende Interessenskonflikte an: Koordinatorin der Leitlinienkommission des DVO. Prof. Dr. Heide Siggelkow gibt folgende Interessenkonflikte an: Mitglied der Leitlinienkommission des DVO., (Thieme. All rights reserved.)
- Published
- 2024
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8. [Update of the S3-guideline on diagnostics, prophylaxis and treatment of osteoporosis].
- Author
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Drey M, Otto S, Thomasius F, and Schmidmaier R
- Subjects
- Humans, Postural Balance, Time and Motion Studies, Osteoporosis diagnosis, Osteoporosis drug therapy, Osteoporosis prevention & control, Bone Density Conservation Agents adverse effects, Fractures, Bone, Osteoporotic Fractures diagnosis, Osteoporotic Fractures prevention & control, Osteoporotic Fractures drug therapy
- Abstract
With the aid of a new fracture risk model, the great treatment gap for osteoporosis should be closed. All patients older than 70 years should undergo a diagnostic procedure for osteoporosis. An additional risk threshold (≥ 10% per 3 years for femoral and vertebral fractures) should enable patients with a high risk of fracture to be treated with osteoanabolic agents. The use of osteoanabolic agents makes it necessary to administer antiresorptive drugs afterwards. Due to the low event rate of osteonecrosis of the jaw, the initiation of a specific osteoporosis treatment should not be delayed by prophylactic dental treatment. The adherence to the drug treatment should be improved by an individualized approach on the basis of a cooperation between patients, caregivers, and physicians. A regular assessment of falls, including the timed up and go test should be carried out in patients older than 70 years., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
- Published
- 2023
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9. [Development of the new guidelines on osteoporosis : Methodological and content development].
- Author
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Thomasius F
- Subjects
- Humans, Risk Factors, Femoral Neck Fractures, Osteoporosis diagnosis, Spinal Fractures prevention & control, Practice Guidelines as Topic
- Abstract
Since 2018, the present S3 guideline Prophylaxis, Diagnosis and Therapy of Osteoporosis (AWMF 183-001) has been updated following a previous update of the underlying PICO questions (Population-Intervention-Comparison-Outcome questions) for a systematic literature search. The focus of the guideline update, in addition to updating the evidence supporting literature along with recommendations, was the development of a risk calculator for vertebral fractures and femoral neck fractures. This is essential for managing risk assessment because of the multitude of risk factors that contribute to fracture risk. This article considers the development of the guideline update methodologically and substantively, the latter by reflecting on the core themes of the guideline update., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2023
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10. Adjuvant pharmacological strategies for the musculoskeletal system during long-term space missions.
- Author
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Thomasius F, Pesta D, and Rittweger J
- Abstract
Despite 2 h of daily exercise training, muscle wasting and bone loss are still present after 6-month missions to the international space station. Some crew members lose bone much faster than others. In preparation for missions to the Moon and Mars, space agencies are therefore reviewing their countermeasure portfolios. Here, we discuss the potential of current pharmacological strategies. Bone loss in space is fuelled by bone resorption. Alendronate, an oral bisphosphonate, reduced bone losses in experimental bed rest and space. However, gastrointestinal side effects precluded its further utilization in space. Zoledronate (a potent bisphosphonate), denosumab (RANKL antagonist) and romosozumab (sclerostin antagonist) are all administered via injection. They effectively suppress bone resorption and are routinely prescribed against osteoporosis. Their serious adverse effects, namely, osteonecrosis of the jaw and atypical femur fractures occur very rarely when the usage is limited to 1 or 2 years. Hence, utilization of one of these compounds may outweigh the bone risks of space travelling, in particular in those with high bone resorption rates. Muscle wasting in space is likely due to hampered muscle protein synthesis. Even though this might theoretically be countered by the synthesis-boosting effects of anabolic steroids, the practical grounds for such recommendation are currently weak. Moreover, they reveal their full potential only when combined with an anabolic exercise stimulus, for example, via strength training. It therefore seems that a combination of exercise and pharmacological countermeasures should be considered for musculoskeletal health on the way to the Moon and Mars and back., (© 2023 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)
- Published
- 2023
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11. Additive Effects of Exercise and Vitamin D Supplementation (with and without Calcium) on Bone Mineral Density in Older Adults: A Systematic Review and Meta-Analysis.
- Author
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Fischer C, Jakob F, Kohl M, Kast S, Von Stengel S, Kerschan-Schindl K, Lange U, Thomasius F, Peters S, Uder M, and Kemmler W
- Abstract
Exercise is a recognized component in the prevention and therapy of osteoporosis. The present systematic review and meta-analysis aimed to determine the effect of Vitamin D (Vit-D) added to exercise versus exercise alone on bone mineral density (BMD) at the lumbar spine (LS) or hip in older adults. A systematic review based on six literature databases according to PRISMA included (a) exercise trials, with an exercise (EX) and a combined exercise + Vit-D group (EX + Vit-D), (b) intervention ≥ 6 months, and (c) BMD assessments at LS or hip. Effects sizes (MD) and 95%-confidence intervals (95%-CI) were calculated using a random-effect model that includes the inverse heterogeneity model (IVhet). Five studies with 281 participants in the EX and 279 participants in the EX + Vit-D were included. No significant differences between EX versus EX + Vit-D were observed for BMD-LS (MD: 0.002, 95%-CI: -0.033 to 0.036) or BMD-hip (MD: 0.003, 95%-CI: -0.035 to 0.042). Heterogeneity between the trial results was moderate-substantial for LS ( I
2 = 0%) and moderate for hip-BMD ( I2 = 35%). The funnel plot analysis suggests evidence for a publication/small study bias for BMD-LS and hip results. In summary, this present systematic review and meta-analysis were unable to determine significant positive interaction of exercise and Vit-D on LS- or hip-BMD. We predominately attribute this finding to (1) the less bone-specific exercise protocols of at least two of the five studies and (2) the inclusion criteria of the studies that did not consequently focus on Vit-D deficiency. This issue should be addressed in more detail by adequately powered exercise trials with promising exercise protocols and participants with Vit-D deficiency. This trial is registered with the International Prospective Register of Systematic Reviews (PROSPERO) ID: CRD42022309813., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2023 Cecilie Fischer et al.)- Published
- 2023
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12. Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
- Author
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Moon RJ, Reginster JY, Al-Daghri NM, Thiyagarajan JA, Beaudart C, Bruyère O, Burlet N, Chandran M, da Silva MC, Conaghan PG, Dere WH, Diez-Perez A, Hadji P, Halbout P, Hiligsmann M, Kanis JA, McCloskey EV, Ormarsdottir S, Prieto-Alhambra D, Radermecker RP, Rizzoli R, Al-Saleh Y, Silverman SL, Simon LS, Thomasius F, van Staa T, Laslop A, Cooper C, and Harvey NC
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- Humans, Societies, Medical, Osteoporosis, Osteoarthritis therapy, Musculoskeletal Diseases therapy
- Abstract
This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research., Purpose: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated., Methods: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice., Results: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research., Conclusions: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings., (© 2023. The Author(s).)
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- 2023
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13. Exercise training and bone mineral density in postmenopausal women: an updated systematic review and meta-analysis of intervention studies with emphasis on potential moderators.
- Author
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Mohebbi R, Shojaa M, Kohl M, von Stengel S, Jakob F, Kerschan-Schindl K, Lange U, Peters S, Thomasius F, Uder M, and Kemmler W
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- Female, Humans, Bone Density, Postmenopause, Exercise, Femur Neck, Lumbar Vertebrae, Osteoporosis, Postmenopausal prevention & control, Osteoporosis
- Abstract
The aim of this systematic review and meta-analysis was (1) to determine exercise effects on bone mineral density (BMD) in postmenopausal women and (2) to address the corresponding implication of bone and menopausal status or supervision in postmenopausal women. A comprehensive search of eight electronic databases according to the PRISMA statement up to August 9, 2022, included controlled exercise trials ≥ 6 months. BMD changes (standardized mean differences: SMD) at the lumbar spine (LS), femoral neck (FN), and total hip (TH) were considered as outcomes. Study group comparisons were conducted for osteopenia/osteoporosis versus normal BMD, early versus late postmenopausal women, and predominantly supervised versus predominantly non-supervised study arms. We applied an inverse heterogeneity (IVhet) model. In summary, 80 studies involving 94 training and 80 control groups with a pooled number of 5581 participants were eligible. The IVhet model determined SMDs of 0.29 (95% CI: 0.16-0.42), 0.27 (95% CI: 0.16-0.39), and 0.41 (95% CI: 0.30-0.52) for LS, FN, and THBMD, respectively. Heterogeneity between the trial results varied from low (I
2 = 20%, TH BMD) to substantial (I2 = 68%, LS-BMD). Evidence for publication bias/small study effects was negligibly low (FN-, TH-BMD) to high (LSBMD). We observed no significant differences (p > .09) for exercise effects on LS-, FN-, or TH-BMD-LS between studies/study arms with or without osteopenia/osteoporosis, early versus late postmenopausal women, or predominantly supervised versus non-supervised exercise programs. Using robust statistical methods, the present work provides further evidence for a positive effect of exercise on BMD in postmenopausal women. Differences in bone status (osteopenia/osteoporosis versus normal bone), menopausal status (early versus late postmenopausal), and supervision (yes versus no) did not significantly affect the exercise effects on BMD at LS or proximal femur., (© 2023. The Author(s).)- Published
- 2023
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14. Correction: Novel formulations of oral bisphosphonates in the treatment of osteoporosis.
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Fuggle N, Al-Daghri N, Bock O, Branco J, Bruyère O, Casado E, Cavalier E, Cortet B, de Wit M, Giusti A, Halbout P, Harvey NC, Hiligsmann M, Kaufman JM, Kurth A, Maggi S, Matijevic R, Minisola S, Palacios S, Radermecker RP, Thomasius F, Tuzun S, Veronese N, Kanis JA, Reginster JY, Rizzoli R, and Cooper C
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- 2023
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15. Fracture risk in women with osteoporosis initiated on gastro-resistant risedronate versus immediate release risedronate or alendronate: a claims data analysis in the USA.
- Author
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Eisman JA, Cortet B, Boolell M, Ionescu-Ittu R, Vekeman F, Heroux J, and Thomasius F
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- Female, Humans, Alendronate therapeutic use, Risedronic Acid therapeutic use, Etidronic Acid therapeutic use, Diphosphonates therapeutic use, Osteoporosis complications, Osteoporosis drug therapy, Osteoporosis epidemiology, Fractures, Bone drug therapy, Bone Density Conservation Agents therapeutic use, Osteoporosis, Postmenopausal complications, Osteoporosis, Postmenopausal drug therapy, Osteoporosis, Postmenopausal epidemiology
- Abstract
The study results indicate that women with osteoporosis initiated on gastro-resistant risedronate have a lower risk of fracture than those initiated on immediate release risedronate or alendronate. A large proportion of women discontinued all oral bisphosphonate therapies within 1 year of treatment start., Purpose: Using a US claims database (2009-2019), we compared risk of fractures between women with osteoporosis initiated on gastro-resistant (GR) risedronate and those initiated on (a) immediate release (IR) risedronate or (b) immediate release alendronate., Methods: Women aged ≥ 60 years with osteoporosis who had ≥ 2 oral bisphosphonate prescription fills were followed for ≥ 1 year after the first observed bisphosphonates dispensing (index date). Fracture risk was compared between the GR risedronate and IR risedronate/alendronate cohorts using adjusted incidence rate ratios (aIRRs), both overall and in subgroups with high fracture risk due to older age or comorbidity/medications. Site-specific fractures were identified based on diagnosis codes recorded on medical claims using a claims-based algorithm. Persistence on bisphosphonate therapy was evaluated for all groups., Results: aIRRs generally indicated lower fracture risk for GR risedronate than IR risedronate and alendronate. When comparing GR risedronate to IR risedronate, statistically significant aIRRs (p < 0.05) were observed for pelvic fractures in the full cohorts (aIRRs = 0.37), for any fracture and pelvic fractures among women aged ≥ 65 years (aIRRs = 0.63 and 0.41), for any fracture and pelvic fractures among women aged ≥ 70 years (aIRRs = 0.69 and 0.24), and for pelvic fracture among high-risk women due to comorbidity/medications (aIRR = 0.34). When comparing GR risedronate to alendronate, statistically significant aIRRs were observed for pelvic fractures in the full cohorts (aIRR = 0.54), for any fracture and wrist/arm fractures among women aged ≥ 65 years (aIRRs = 0.73 and 0.63), and for any fracture, pelvic, and wrist/arm fractures among women aged ≥ 70 years (aIRRs = 0.72, 0.36, and 0.58). In all cohorts, ~ 40% completely discontinued oral bisphosphonates within 1 year., Conclusions: Discontinuation rates of oral bisphosphonate therapy were high. However, women initiated on GR risedronate had a significantly lower risk of fracture for several skeletal sites than women initiated on IR risedronate/alendronate, particularly those aged ≥ 70 years., (© 2023. The Author(s).)
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- 2023
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16. The effect of aquatic exercise on bone mineral density in older adults. A systematic review and meta-analysis.
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Schinzel E, Kast S, Kohl M, von Stengel S, Jakob F, Kerschan-Schindl K, Kladny B, Lange U, Peters S, Thomasius F, Clausen J, Uder M, and Kemmler W
- Abstract
Introduction: Aquatic or water-based exercise is a very popular type of exercise in particular for people with physical limitations, joint problems and fear of falling. The present systematic review and meta-analysis aimed to provide evidence for the effect of aquatic exercise on Bone Mineral Density (BMD) in adults. Methods: A systematic literature search of five electronic databases (PubMed/MEDLINE, Cochrane Library, Scopus, Web of Science and CINAHL) according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was conducted until 2022/01/30, with an update to 2022/10/07. We included controlled trials with a duration of more than 6 months and at least two study groups, aquatic exercise (EG) versus non-training controls (CG) with no language restrictions. Outcome measures were standardized mean differences (SMD) with 95%-confidence intervals (95%-CI) for BMD changes at the lumbar spine (LS) and femoral neck (FN). We applied a random-effects meta-analysis and used the inverse heterogeneity (IVhet) model to analyze the data. Results: Excluding an outlier study with an exceptionally high effect size for LS-BMD, we observed a statistically significant ( p = .002) effect (EG vs. CG) of aquatic exercise for the LS-BMD (n = 10; SMD: 0.30; 95%-CI: 0.11-0.49). In parallel, the effect of aquatic exercise on FN-BMD was statistically significant ( p = .034) compared to the CG (n = 10; SMD: 0.76, 95%-CI: 0.06-1.46). Of importance, heterogeneity between the trial results was negligible for LS (I
2 : 7%) but substantial for FN-BMD (I2 : 87%). Evidence for risks of small study/publication bias was low for LS-BMD and considerable for FN-BMD. Discussion: In summary, the present systematic review and meta-analysis provides further evidence for the favorable effect of exercise on bone health in adults. Due to its safety and attractiveness, we particularly recommend water-based exercise for people unable, afraid or unmotivated to conduct intense land-based exercise programs., (Copyright © 2023 Schinzel, Kast, Kohl, von Stengel, Jakob, Kerschan-Schindl, Kladny, Lange, Peters, Thomasius, Clausen, Uder and Kemmler.)- Published
- 2023
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17. Exercise effects on glucocorticoid-induced bone loss in adults: a systematic review and meta-analysis.
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Kast S, Jakob F, Kohl M, von Stengel S, Kerschan-Schindl K, Lange U, Thomasius F, and Kemmler W
- Abstract
Objectives: Due to their pronounced anti-inflammatory and immunosuppressive effects, glucocorticoids (GCs) are widely used in inflammatory conditions and organ transplants. Unfortunately, GC-induced osteoporosis is one of the most common causes of secondary osteoporosis. The aim of the present systematic review and meta-analysis was to determine the effect of exercise added to GC therapy on BMD at the lumbar spine or femoral neck in people on GC therapy., Methods: A systematic literature search of five electronic databases included controlled trials with a duration of >6 months and at least two study arms [glucocorticoids (GCs) and GCs and exercise (GC + EX)] were conducted up to 20 September 2022. Studies involving other pharmaceutical therapies with relevant effects on bone metabolism were excluded. We applied the inverse heterogeneity model. Outcome measures were standardized mean differences (SMDs) with 95% CIs for BMD changes at the lumbar spine (LS) and femoral neck (FN)., Results: We identified three eligible trials with a total of 62 participants. In summary, the GC + EX intervention indicated statistically significantly higher SMDs for LS-BMD [SMD 1.50 (95% CI 0.23, 2.77)] but not for FN-BMD [0.64 (95% CI -0.89, 2.17)] compared with GC treatment alone. We observed substantial heterogeneity (LS-BMD I
2 = 71%, FN-BMD I2 = 78%) between the study results., Conclusion: Although more well-designed exercise studies are needed to address the issue of exercise effects on GC-induced osteoporosis (GIOP) in more detail, upcoming guidelines should pay more attention to the aspect of exercise for bone strengthening in GIOP., Registration Number: PROSPERO: CRD42022308155., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)- Published
- 2023
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18. Exercise and the prevention of major osteoporotic fractures in adults: a systematic review and meta-analysis with special emphasis on intensity progression and study duration.
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Hoffmann I, Kohl M, von Stengel S, Jakob F, Kerschan-Schindl K, Lange U, Peters S, Schoene D, Sieber C, Thomasius F, Bischoff-Ferrari HA, Uder M, and Kemmler W
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- Humans, Aged, Exercise, Exercise Therapy methods, Aging, Quality of Life, Osteoporotic Fractures etiology, Osteoporotic Fractures prevention & control
- Abstract
The role of exercise in preventing osteoporotic fractures is vague, and further recommendations for optimized exercise protocols are very rare. In the present work, we provided positive evidence for exercise effects on the number of osteoporotic fractures in adults, albeit without observing any significant relevance of intensity progression or study duration., Introduction: Osteoporotic fractures are a major challenge confronting our aging society. Exercise might be an efficient agent for reducing osteoporotic fractures in older adults, but the most promising exercise protocol for that purpose has yet to be identified. The present meta-analysis thus aimed to identify important predictors of the exercise effect on osteoporotic fractures in adults., Methods: We conducted a systematic search of six literature databases according to the PRISMA guideline that included controlled exercise studies and reported the number of low-trauma major osteoporotic fractures separately for exercise (EG) and control (CG) groups. Primary study outcome was incidence ratio (IR) for major osteoporotic fractures. Sub-analyses were conducted for progression of intensity (yes vs. no) during the trial and the study duration (≤ 12 months vs. > 12 months)., Results: In summary, 11 studies with a pooled number of 9715 participant-years in the EG and 9592 in the CG were included. The mixed-effects conditional Poisson regression revealed positive exercise effects on major osteoporotic fractures (RR: 0.75, 95% CI: 0.54-0.94, p = .006). Although studies with intensity progression were more favorable, our subgroup analysis did not determine significant differences for diverging intensity progression (p = .133) or study duration (p = .883). Heterogeneity among the trials of the subgroups (I
2 ≤ 0-7.1%) was negligible., Conclusion: The present systematic review and meta-analysis provided significant evidence for the favorable effect of exercise on major osteoporotic fractures. However, diverging study and exercise characteristics along with the close interaction of exercise parameters prevented the derivation of reliable recommendations for exercise protocols for fracture reductions., Prospero Id: CRD42021250467., (© 2022. The Author(s).)- Published
- 2023
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19. Exercise Reduces the Number of Overall and Major Osteoporotic Fractures in Adults. Does Supervision Make a Difference? Systematic Review and Meta-Analysis.
- Author
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Hoffmann I, Shojaa M, Kohl M, von Stengel S, Becker C, Gosch M, Jakob F, Kerschan-Schindl K, Kladny B, Clausen J, Lange U, Middeldorf S, Peters S, Schoene D, Sieber C, Tholen R, Thomasius F, Bischoff-Ferrari HA, Uder M, and Kemmler W
- Subjects
- Middle Aged, Humans, Aged, Exercise, Fracture Fixation, Bone and Bones, Osteoporotic Fractures epidemiology
- Abstract
The purpose of this systematic review and meta-analysis (PROSPERO ID: CRD42021250467) was to evaluate the effects of exercise on low-trauma overall and major osteoporotic fractures (hip, spine, forearm, or humerus fractures) and to determine the corresponding effect of supervision of the exercise program. Our systematic search of six literature databases according to the PRISMA guideline was conducted from January 1, 2013 (ie, date of our last search) to May 22, 2021, and included controlled clinical exercise trials with (i) individuals aged ≥45 years, (ii) cohorts without therapies/diseases related to fractures, (iii) observation periods of ≥3 months, and (iv) the number of low-trauma fractures listed separately for the exercise (EG) and control (CG) groups. We included 20 intervention studies with 21 EGs and 20 CGs comprising a pooled number of participant-years of n = 11.836 in the EG and n = 11.275 in the CG. The mixed-effects conditional Poisson regression revealed significant effects of exercise on low-trauma overall incidence (rate) ratio (IR 0.67, 95% confidence interval [95% CI] 0.51-0.87) and major osteoporotic fractures IR (0.69, 95% CI 0.52-0.92). Heterogeneity between the trials was moderate for low-trauma overall (I2 = 40%) and negligible (I2 < 1%) for major osteoporotic fractures. Supervision of the exercise program plays a significant role in the reductions of overall and major osteoporotic fractures with IR about twice as favorable in the predominately supervised (IR 0.44; 95% CI 0.27-0.73 and 0.38; 0.19-0.76) versus the predominately non-supervised exercise trials (IR 0.83; 95% CI 0.60-1.14 and 0.82; 0.64-1.05). In summary, the present study provides evidence for the positive effect of exercise on low-trauma overall and major osteoporotic fractures in middle aged to older adults. Supervision of the exercise program is a crucial aspect in exercise programs on fracture reduction. Thus, home-based exercise protocols should increasingly implement online classes to ensure widely consistent supervision and monitoring of the exercise program. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR)., (© 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).)
- Published
- 2022
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20. Novel formulations of oral bisphosphonates in the treatment of osteoporosis.
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Fuggle N, Al-Daghri N, Bock O, Branco J, Bruyère O, Casado E, Cavalier E, Cortet B, de Wit M, Giusti A, Halbout P, Harvey NC, Hiligsmann M, Kaufman JM, Kurth A, Maggi S, Matijevic R, Minisola S, Palacios S, Radermecker RP, Thomasius F, Tuzun S, Veronese N, Kanis JA, Reginster JY, Rizzoli R, and Cooper C
- Subjects
- Humans, Diphosphonates adverse effects, Risedronic Acid therapeutic use, Alendronate adverse effects, Osteoporosis drug therapy, Fractures, Bone
- Abstract
Oral bisphosphonates are a key intervention in the treatment of osteoporosis and in reducing the risk of fragility fractures. Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms. This problem has led to the development of novel oral bisphosphonate formulations. Buffered, effervescent alendronate is dissolved in water and so seeks to reduce upper gastro-intestinal adverse events, and gastro-resistant risedronate aims to reduce the complexity of dosing procedure (e.g. fasting prior to consumption) whilst still maintaining the efficacy of fracture risk reduction. Clinical trials and real-world data have been employed to demonstrate some benefits in terms of reduced upper gastro-intestinal adverse events, adherence, persistence and health economic outcomes. This report describes the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores where oral bisphosphonates sit in current clinical practice guidelines, review their risk-benefit profile and the consequences of poor adherence before exploring novel oral bisphosphonate formulations and their potential clinical and health economic impact. Further research is required but there are signs that these novel, oral bisphosphonate formulations may lead to improved tolerance of oral bisphosphonates and thus, improved adherence and fracture outcomes., (© 2022. The Author(s).)
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- 2022
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21. Effects of Hormone Therapy and Exercise on Bone Mineral Density in Healthy Women-A Systematic Review and Meta-analysis.
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Born C, Jakob F, Shojaa M, Kohl M, von Stengel S, Kerschan-Schindl K, Lange U, Thomasius F, and Kemmler W
- Subjects
- Estrogens pharmacology, Exercise physiology, Female, Femur Neck, Humans, Lumbar Vertebrae, Bone Density, Osteoporosis, Postmenopausal metabolism
- Abstract
Context: There is some evidence that an adequate "anabolic hormonal milieu" is essential for the mechanosensitivity/transduction/response of bone tissue., Objective: This work aimed to determine whether enhancing hormone therapy (HT) with exercise increases the isolated effect of HT on bone mineral density (BMD) at the lumbar spine (LS) and femoral neck (FN)., Methods: A comprehensive search of 6 electronic databases according to the PRISMA statement up to April 28, 2021, included controlled trials longer than 6 months with 3 study arms: (a) HT, (b) exercise, and (c) HT plus exercise (HT + E). Apart from HT, no pharmaceutic therapy or diseases with relevant osteoanabolic or osteocatabolic effect on bone metabolism were included. The present analysis was conducted as a random-effects meta-analysis. Outcome measures were standardized mean differences (SMD) for BMD changes at the LS and FN., Results: Our search identified 6 eligible studies (n = 585). Although the effect of HT + E was more pronounced in the LS (SMD: 0.19; 95% C,: -0.15 to 0.53) and FN-BMD (0.18; -0.09 to 0.44) compared to the HT group, we did not observe significant differences between the 2 groups. We observed a low (I2: 29%) or moderate (I2: 49%) level of heterogeneity between the trials for FN or LS., Conclusion: We do not observe a significant effect of HT + E vs HT alone. We largely attribute this result to varying HT supplementation and hormonal status. Bearing in mind that synergistic/additive effects between HT and mechanical stimulation can only be expected in situations of hormonal insufficiency, further clinical studies should consider baseline endogenous estrogen production but also HT dosing more carefully., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2022
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22. Management of patients at very high risk of osteoporotic fractures through sequential treatments.
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Curtis EM, Reginster JY, Al-Daghri N, Biver E, Brandi ML, Cavalier E, Hadji P, Halbout P, Harvey NC, Hiligsmann M, Javaid MK, Kanis JA, Kaufman JM, Lamy O, Matijevic R, Perez AD, Radermecker RP, Rosa MM, Thomas T, Thomasius F, Vlaskovska M, Rizzoli R, and Cooper C
- Subjects
- Bone Density, Humans, Anabolic Agents pharmacology, Anabolic Agents therapeutic use, Bone Density Conservation Agents therapeutic use, Osteoporosis complications, Osteoporosis drug therapy, Osteoporotic Fractures drug therapy, Osteoporotic Fractures prevention & control
- Abstract
Osteoporosis care has evolved markedly over the last 50 years, such that there are now an established clinical definition, validated methods of fracture risk assessment and a range of effective pharmacological agents. Currently, bone-forming (anabolic) agents, in many countries, are used in those patients who have continued to lose bone mineral density (BMD), patients with multiple subsequent fractures or those who have fractured despite treatment with antiresorptive agents. However, head-to-head data suggest that anabolic agents have greater rapidity and efficacy for fracture risk reduction than do antiresorptive therapies. The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) convened an expert working group to discuss the tools available to identify patients at high risk of fracture, review the evidence for the use of anabolic agents as the initial intervention in patients at highest risk of fracture and consider the sequence of therapy following their use. This position paper sets out the findings of the group and the consequent recommendations. The key conclusion is that the current evidence base supports an "anabolic first" approach in patients found to be at very high risk of fracture, followed by maintenance therapy using an antiresorptive agent, and with the subsequent need for antiosteoporosis therapy addressed over a lifetime horizon., (© 2022. The Author(s).)
- Published
- 2022
- Full Text
- View/download PDF
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