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12. Effect of stress on the paracellular barrier in the rat ileum. (Small Intestine)

Author

Mazzon, E., Sturniolo, G.C., Puzzolo, D., Frisina, N., and Fries, W.

Subjects
Immunohistochemistry -- Research -- Physiological aspects -- Usage, Intestine, Small -- Physiological aspects -- Usage -- Research, Membrane proteins -- Physiological aspects -- Research -- Usage, Ileum -- Physiological aspects -- Research -- Usage, Rats as laboratory animals -- Physiological aspects -- Usage -- Research, Stress (Psychology) -- Physiological aspects -- Research, Health, Physiological aspects, Usage, Research
Abstract

Background: Restraint stress induces permeability changes in the rat small intestine but little is known of the ultrastructural events leading to defects of the paracellular sealing or of the short [...]

Published
2002

17. The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment

Author

Window, Trova@UniTO(opens in a. new, Export, Download | Add to List | More,, Rheumatology, Clinical, Experimental, Volume 34, Issue 2, The Italian observational study on severe osteoporosis: 24 month results on incidence of fractures, adherence to treatment Idolazzi, L. Abb, Maugeri, D. B, Monti, S. C, Massarotti, M. D, Osella, G. E, Barbagallo, M. F, Del Fiacco, R. G, Silvestri, S. G, Adami, S. H, Altomonte, L. I, Bardoscia, A. J, Bertoldo, F. K, Bevilacqua, M. L, Bianchi, G. M, Brancati, A. N, Cagnoni, C. O, Cantatore, F. P. P, Capone, A. Q, Costanzo, G. R, D'Avola, G. S, De Giorgi, G. T, Di Matteo, L. U, Di Munno, O. V, Filipponi, P. W, Frisina, N. X, Fusco, A. Y, Giannini, S. Z, Guiducci, S. Aa, Iolascon, G. Ab, Isaia, Giovanni Carlo, Lombardi, G. Ad, Malavolta, N. Ae, Marcocci, C. Af, Migliaccio, S. Ag, Migliore, A. Ah, Muratore, M. Ai, Nardi, A. Aj, Ortolani, S. Ak, Pasquali, R. Al, Petto, H. Am, Pietrogrande, L. An, Pola, E. Ao, Previti, B. Ap, Resmini, G. Aq, Rubinacci, A. Ar, Russo, E. As, Scillitani, A. At, Silveri, F. Au, Leali, P. T. Av, Trotta, F. Aw, Ulivieri, M. Ax, Verdoia, C. Ay, Versace, F. Az, Vinicola, V. Ba, Idolazzi, Luca, Maugeri, Domenico, Monti, Salvatore, Massarotti, Marco, Osella, Giangiacomo, Barbagallo, Mario, Del Fiacco, Romano, Silvestri, Sandra, Adami, S, Altomonte, L, Barbagallo, M, Bardoscia, A, delle Murge, C, Bertoldo, F, Bevilacqua, M, Bianchi, G, Brancati, A, Cagnoni, C, Cantatore, Fp, Capone, A, DI COSTANZO, Gennaro, D'Avola, G, De Giorgi, G, Di Matteo, L, Di Munno, O, Filipponi, P, Frisina, N, Fusco, A, Giannini, S, Guiducci, S, Iolascon, G, Isaia, G, Lombardi, G, Malavolta, N, Marcocci, C, Migliaccio, S, Migliore, A, Muratore, M, Nardi, A, Ortolani, S, Osella, G, Pasquali, R, Petto, H, Pietrogrande, L, Pola, E, Previti, B, Resmini, G, Rubinacci, A, Russo, Pina Elvira, Scillitani, A, Silveri, F, Leali, Pt, Trotta, F, Ulivieri, M, Verdoia, C, Versace, F, and Vinicola, V.

Subjects
Aged, 80 and over, Male, Spinal fracture, Incidence, Osteoporosi, Middle Aged, Parathyroid hormone, Spine, Medication Adherence, Fracture, Observational study, Osteoporosis therapy, Teriparatide, 80 and over, Settore MED/33 - Malattie Apparato Locomotore, Humans, Osteoporosis, Female, Prospective Studies, Aged, Osteoporotic Fractures
Abstract

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study. Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Published
2016

19. Treatment adherence and QoL with intermittent PTH therapy: Results from a multicentre Italian study after 6 months

Author

Minisola, S., Patella, V., Sessa, G., Raso, I., Bevilacqua, M., Fabbri, A., Moretti, B., Scarpellini, M., Cangelosi, A., Letizia Mauro, G., Frisina, N., Mancusi, D., Minisola, S., Patella, V., Sessa, G., Raso, I., Bevilacqua, M., Fabbri, A., Moretti, B., Scarpellini, M., Cangelosi, A., Letizia Mauro, G., Frisina, N., and Mancusi, D.

Subjects
Settore MED/34 - Medicina Fisica E Riabilitativa, Qol, PTH therapy, osteoporosis, vertebral fractures
Abstract

This ongoing multicentre study was carried out to investigate the adherence to intermittent parathyroid hormone treatment and the effect on QoL in a typical Italian population eligible for drug reimbursement (i.e. a new vertebral or hip fracture following at least one year of anti-resorptive therapy or three severe vertebral fractures or two severe and one femur fracture). 204 female patients (mean age: 72.6±8.3) were enrolled between March 2008 and April 2009. These patients were treated with PTH (PTH 1–34 or PTH 1–84) according to Italian legislation. Here, we report the results obtained at month 6.

Published
2011

20. Baseline characteristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO)

Author

Adami S, Maugeri D, Toscano V, Monti S, Vottari S, Topa G, Malavolta N, Buffa A, Brancati A, Massarotti M, Osella G, Iolascon G, Cagnoni C, Camozzi V, Verdoia C, Corradini C, Nardi A, Ulivieri FM, Resmini G, Isaia G, Bevilacqua M, Ortolani S, Pietrogrande L, Rubinacci A, Giannini S, Lo Cascio V, Lacorte R, Massari L, Marcocci C, Di Munno O, Matucci-Cerinic M, Bianchi G, Filipponi P, Mannarino E, Migliaccio S, Spera G, Fornari R, Migliore A, Pola E, Costanzo G, De Marinis L, Di Matteo L, Lombardi G, Altomonte L, Silveri F, Cantatore FP, Scillitani A, Muratore M, Russo E, Salomone S, Barbagallo M, Previti B, Velluti C, Tranquilli Leali P, De Giorgi G, Vinicola V, Vedova D, Frisina N, Stisi S, Gallo A, Bardoscia A, Adami, S, Maugeri, D, Toscano, V, Monti, S, Vottari, S, Topa, G, Malavolta, N, Buffa, A, Brancati, A, Massarotti, M, Osella, G, Iolascon, G, Cagnoni, C, Camozzi, V, Verdoia, C, Corradini, C, Nardi, A, Ulivieri, Fm, Resmini, G, Isaia, G, Bevilacqua, M, Ortolani, S, Pietrogrande, L, Rubinacci, A, Giannini, S, Lo Cascio, V, Lacorte, R, Massari, L, Marcocci, C, Di Munno, O, Matucci-Cerinic, M, Bianchi, G, Filipponi, P, Mannarino, E, Migliaccio, S, Spera, G, Fornari, R, Migliore, A, Pola, E, Costanzo, G, De Marinis, L, Di Matteo, L, Lombardi, G, Altomonte, L, Silveri, F, Cantatore, Fp, Scillitani, A, Muratore, M, Russo, E, Salomone, S, Barbagallo, M, Previti, B, Velluti, C, Tranquilli Leali, P, De Giorgi, G, Vinicola, V, Vedova, D, Frisina, N, Stisi, S, Gallo, A, and Bardoscia, A

Abstract

OBJECTIVES: Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. METHODS: Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, bone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. RESULTS: Most patients were elderly women (90.5%), mean age±SD was 72.9±8.8 years. Nearly all (91.3%) had experienced ≥ 1 vertebral fracture (mean±SD, 3.6±2.2 per patient), 37.5% had ≥ 1 non-vertebral fracture (mean±SD, 1.4±0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58±0.25 and VAS score 49.2±23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p

Published
2011

22. Baseline charateristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO)

Author

Adami, S, Maugeri, D, Toscano, V, Topa, G, Carminiti, M, Brancati, A, Massarotti, M, Osella, G, Malavolta, N, Iolascon, G, Cagnoni, C, Camozzi, V, Corradini, C, Nardi, A, Migliaccio, S, Ulivieri, F. M, Resmini, G, Valle, D, Tauchmanovà, L, Silvestri, S, Monti, S, Vottari, S, Buffa, A, Verdoia, C, Ulivieri, Fm, Isaia, G, Bevilacqua, M, Ortolani, S, Pietrogrande, L, Rubinacci, A, Giannini, Sandro, Lo Cascio, V, Lacorte, R, Massari, L, Marcocci, C, Di Munno, O, Matucci Cerinic, M, Bianchi, G, Filipponi, P, Mannarino, E, Spera, G, Fornari, R, Migliore, A, Pola, E, Costanzo, G, De Marinis, L, Di Matteo, L, Lombardi, G, Altomonte, L, Silveri, F, Cantatore, Fp, Scillitani, A, Muratore, M, Russo, E, Salomone, S, Barbagallo, M, Previti, B, Velluti, C, Tranquilli Leali, P, De Giorgi, G, Vinicola, V, Vedova, D, Frisina, N, Stisi, S, Gallo, A, Bardoscia, A., Adami, S, Maugeri, D, Toscano, V, Topa, G, Caminiti, M, Brancati, A, Massarotti, M, Osella, G, Malavolta, N, Iolascon, Giovanni, Cagnoni, C, Camozzi, V, Corradini, C, Nardi, A, Migliaccio, S, Ulivieri, Fm, Resmini, G, Valle, D, Tauchmanova, L, and Silvestri, S.

Subjects
Male, Severity of Illness Index, Cohort Studies, Fractures, Bone, fractures, osteoporosis, treatment, quality of life, observational study, back pain, risk factors, Risk Factors, Teriparatide, 80 and over, severe osteoporosis, Humans, Longitudinal Studies, Prospective Studies, Bone, Aged, Retrospective Studies, Aged, 80 and over, Bone Density Conservation Agents, Incidence, Data Collection, Middle Aged, Italy, Back Pain, Female, Osteoporosis, Quality of Life, Spinal Fractures, Fractures
Abstract

Objective Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. Methods Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, hone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. Results Most patients were elderly women (90.5%), mean age +/- SD was 72.9 +/- 8.8 years. Nearly all (91.3%) had experienced >= 1 vertebral fracture (mean +/- SD, 3.6 +/- 2.2 per patient), 37.5% had >= 1 non-vertebral fracture (mean +/- SD, 1.4 +/- 0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58 +/- 0.25 and VAS score 49.2 +/- 23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p

Published
2011

24. Osteoporosis treatment and fracture incidence: the ICARO longitudinal study

Author

Adami, Silvano, Isaia, G, Luisetto, G, Minisola, S, Sinigaglia, L, Silvestri, S, Agnusdei, D, Gentilella, R, Nuti, R, Albanese, C, Antonelli, M, Aversa, A, Bancheri, C, Barbagallo, M, Bardoscia, A, Bertoni, P, Bianchi, G, Biondi, M, Brandi, Ml, Calitro, M, Cangelosi, R, Cantatore, Fp, Cenci, G, Cianci, A, Coppi, G, DALLE CARBONARE, Luca Giuseppe, D'Amore, M, D'Avola, G, De Candia, R, Del Puente, A, Delvino, Pg, Di Felice, A, Filipponi, P, Fiore, Ce, Francucci, Cm, Frediani, B, Frisina, N, Fruttero, B, Ghirardi, R, Giuntini, D, Giustina, A, Lentini, G, LO CASCIO, Vincenzo, Lucchese, V, Manzara, A, Matina, A, Maugeri, D, Mela, Q, Nardi, A, Occhipinti, R, Osella, G, Perpignano, G, Pisciotta, E, Quattrocchi, G, Rini, G, Rossini, Maurizio, Savoca, S, Silveri, F, and Termini, G.

Subjects
fracture, Osteoporosis, ICARO
Published
2008

25. Erytropoietin: A novel DABA?

Author

Morabito, Nunziata, Gaudio, A, Galati, Em, Pergolizzi, Simona, Taviano, Mf, Lasco, A, Macri', I, Catalano, Antonino, Atteritano, Marco, Occhiuto, Francesco, Corrente, E, Crisafulli, G, and Frisina, N.

Published
2008

30. Erythropoietin: a novel D.A.B.A.?

Author

Morabito, Nunziata, Gaudio, A, Pergolizzi, Simona, Taviano, Maria Fernanda, Lasco, A, Macrì, I, Catalano, Antonino, Atteritano, Marco, Corrente, E, Crisafulli, G, Frisina, N, and Galati, E. M.

Published
2007

35. Raloxifene and pituitary secretion in post-menopausal women

Author

Lasco, A., Cannavò, S., Agostino GAUDIO, Morabito, N., Trifiletti, A., Di Cesare, E., Basile, G., Nicita-Mauro, V., and Frisina, N.

Subjects
Postmenopause, Selective Estrogen Receptor Modulators, Pituitary Gland, Raloxifene Hydrochloride, Humans, Female, Follicle Stimulating Hormone, Luteinizing Hormone, Middle Aged, Drug Administration Schedule, Prolactin
Published
2002

36. Recombinant human erythropoietin (rHuEPO): More than just the correction of uremic anemia

Author

Buemi, M., Aloisi, C., Cavallaro, E., Corica, F., Floccari, F., giovanni grasso, Lasco, A., Pettinato, G., Ruello, A., Sturiale, A., and Frisina, N.

Subjects
Erythropoietin (EPO), proliferation, maturation and differentiation of the erythroid cell line, vascular endothelial growth factor (VEGF, endothelial cell mitosis and motility, neovascularization, Myeloproliferative Disorders, Brain, Neovascularization, Physiologic, Anemia, Shock, Recombinant Proteins, Hematopoiesis, Humans, Erythropoietin
Abstract

Hematopoiesis is controlled by numerous interdependent humoral and endocrine factors. Erythropoietin (EPO), a hydrophobic sialoglycoproteic hormone, plays a crucial role in the regulation of hematopoiesis, and induces proliferation, maturation and differentiation of the erythroid cell line precursors. Thanks to recombinant DNA techniques, different recombinant hormones can now be produced at low cost and in large amounts. This has led to greater understanding of the pathophysiological factors regulating hematopoiesis. This in turn, hasprompted the search for new therapeutic approaches. EPO might also be used to treat patients with different types of anemia: uremics, newborns, patients with anemia from cancer or myeloproliferative disease, thalassemia, bone marrow transplants, chronic infectious diseases. Besides erythroid cells, EPO affects other blood cell lines, such as myeloid cells, lymphocytes and megakaryocytes. It can also enhance polymorphonuclear cell phagocytosis and reduce macrophage activation, thus modulating the inflammatory process. Hematopoietic and endothelial cells probably have the same origin, and the discovery of eyrthropoietin receptors also on mesangial, myocardial and smooth muscle cells has prompted research into the non-erythropoietic function of the hormone. EPO has an important, direct, hemodynamic and vasoactive effect, which does not depend only on an increase in hematocrit and viscosity. Moreover, EPO and its receptors have been found in the brain, suggesting a role in preventing neuronal death. Finally, the recently discovered interaction between EPO and vascular endothelial growth factor (VEGF), and the ability of EPO to stimulate endothelial cell mitosis and motility may be of importance in neovascularization and wound healing.

Published
2002

42. Efficacy of genistein aglycone on some cardiovascular risk factors and homocysteine levels: A follow-up study.

Author

Marini, H., Bitto, A., Altavilla, D., Burnett, B.P., Polito, F., Di Stefano, V., Minutoli, L., Atteritano, M., Levy, R.M., Frisina, N., Mazzaferro, S., Frisina, A., D'Anna, R., Cancellieri, F., Cannata, M.L., Corrado, F., Lubrano, C., Marini, R., Adamo, E.B., and Squadrito, F.

Abstract

Abstract: Background and Aim: Recent evidence suggests that genistein aglycone may act beneficially on surrogate cardiovascular risk markers in postmenopausal women. We assessed the effects of genistein aglycone on some cardiovascular risk factors and homocysteine levels after 3-years of continued therapy in a cohort of osteopenic, postmenopausal women. Methods and Results: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 postmenopausal women with low bone mass for 24 months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Participants received 54mg of genistein aglycone (n =71) or placebo (n =67), daily. Both arms received calcium and vitamin D3 in therapeutic doses. Moreover, 4 weeks before randomization procedures and during our follow-up study, all patients received dietary instructions in an isocaloric fat-restricted diet. Blood lipid profiles, fasting glucose and insulin, insulin resistance (HOMA-IR), fibrinogen, osteoprotegerin (OPG) and homocysteine at baseline and after 24 and 36 months of treatment were measured. Compared to placebo, genistein significantly decreased fasting glucose and insulin, HOMA-IR, fibrinogen and homocysteine after 24 and 36 months of treatment. By contrast, isoflavone administration did not affect high-density lipoprotein cholesterol and triglycerides though serum OPG was higher in the genistein recipients. There were no differences in adverse events or discomfort between groups. Results on routine biochemical, liver function, and hematologic testing did not change over time in placebo or genistein group. Conclusions: After 3-years of treatment, genistein aglycone plus calcium, vitamin D3 and a healthy diet showed positive effects on some cardiovascular risk factors and homocysteine levels in a cohort of postmenopausal women with low bone mass. [Copyright &y& Elsevier]

Published
2010
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45. Pulmonary Hypertension and Erythropoietin.

Author

Buemi, M., Senatore, M., Gallo, G. C., Crascì, E., Campo, S., Sturiale, A., Coppolino, G., Bolignano, D., and Frisina, N.

Subjects
HYPERTENSION, ERYTHROPOIETIN, HEMOLYTIC-uremic syndrome, HEMODIALYSIS, ARTERIOVENOUS fistula, CALCIFICATION
Abstract

Numerous uremic patients on hemodialysis have pulmonary hypertension attributable to the presence of arteriovenous fistulas, vascular calcification, and endothelial dysfunction due to alterations in the balance between vasoconstrictive and vasodilatory substances. For these reasons, the effects of recombinant human erythropoietin, a drug widely used in patients on dialysis, on the pulmonary circulation were studied. Some authors maintain that recombinant human erythropoietin has an antihypertensive effect, while others have observed that this hormone induces a reduction in pulmonary arterial pressure due to its vasoactive and stimulatory effects on endothelial and smooth muscle cell precursors. Copyright © 2007 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2007
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46. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial.

Author

Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F, Marini, Herbert, and Minutoli, Letteria

Abstract

Background: Observational studies and small trials of short duration suggest that the isoflavone phytoestrogen genistein reduces bone loss, but the evidence is not definitive.Objective: To assess the effects of genistein on bone metabolism in osteopenic postmenopausal women.Design: Randomized, double-blind, placebo-controlled trial.Setting: 3 university medical centers in Italy.Patients: 389 postmenopausal women with a bone mineral density (BMD) less than 0.795 g/cm2 at the femoral neck and no significant comorbid conditions.Intervention: After a 4-week stabilization period during which participants received a low-soy, reduced-fat diet, participants were randomly assigned to receive placebo (n = 191) or 54 mg of genistein (n = 198) daily for 24 months. Both the genistein and placebo tablets contained calcium and vitamin D.Measurements: The primary outcome was BMD at the anteroposterior lumbar spine and femoral neck at 24 months. Secondary outcomes were serum levels of bone-specific alkaline phosphatase and insulin-like growth factor I, urinary excretion of pyridinoline and deoxypyridinoline, and endometrial thickness. Data on adverse events were also collected.Results: At 24 months, BMD had increased in genistein recipients and decreased in placebo recipients at the anteroposterior lumbar spine (change, 0.049 g/cm2 [95% CI, 0.035 to 0.059] vs. -0.053 g/cm2 [CI, -0.058 to -0.035]; difference, 0.10 g/cm2 [CI, 0.08 to 0.12]; P < 0.001) and the femoral neck (change, 0.035 g/cm2 [CI, 0.025 to 0.042] vs. -0.037 g/cm2 [CI, -0.044 to -0.027]; difference, 0.062 g/cm2 [CI, 0.049 to 0.073]; P < 0.001). Genistein statistically significantly decreased urinary excretion of pyridinoline and deoxypyridinoline, increased levels of bone-specific alkaline phosphatase and insulin-like growth factor I, and did not change endometrial thickness compared with placebo. More genistein recipients than placebo recipients experienced gastrointestinal side effects (19% vs. 8%; P = 0.002) and discontinued the study.Limitations: The study did not measure fractures and had limited power to evaluate adverse effects.Conclusion: Twenty-four months of treatment with genistein has positive effects on BMD in osteopenic postmenopausal women. ClinicalTrials.gov registration number: NCT00355953. [ABSTRACT FROM AUTHOR]

Published
2007
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48. Osteoprotegerin and Bone Mineral Density in Hemodiafiltration Patients.

Author

Crisafulli, A., Romeo, A., Floccari, F., Aloisi, E., Atteritano, M., Cincotta, M., Aloisi, C., Pizzoleo, M. A., Ruello, A., Artemisia, A., Valenti, A., Frisina, N., Teti, D., and Buemi, Michele

Subjects
BONES, CYTOKINES, CHRONIC kidney failure, RENAL osteodystrophy, BLOOD testing
Abstract

A newly identified cytokine, osteoprotegerin (OPG) appears to be involved in the regulation of bone remodeling. In vitro studies suggest that OPG, a soluble member of the TNF receptor family of proteins, inhibits osteoclastogenesis by interrupting the intercellular signaling between osteoblastic stromal cells and osteoclast progenitors. As patients with chronic renal failure (CRF) often have renal osteodystrophy (ROD), we investigated the role of osteoprotegerin (OPG) in ROD, and investigated whether there was any relationship between serum OPG, intact parathyroid (PTH) (iPTH), vitamin D, and trabecular bone. Serum OPG combined with iPTH might be a useful tool in the noninvasive diagnosis of ROD, at least in cases in which the range of PTH values compromises reliable diagnosis. Thirty-six patients on maintenance hemodiafiltration (HDF) and a control group of 36 age and sex matched healthy subjects with no known metabolic bone disease were studied. The following assays were made on serum: iPTH, osteocalcin (BGP), bone alkaline phosphatase, 25(OH)-cholecalciferol, calcium, phosphate, OPG, IGF-1, estradiol, and free testosterone. Serum Ca + + , P, B-ALP, BGP, IGF-1, iPTH, and OPG levels were significantly higher in HDF patients than in controls, while DXA measurements and quantitative ultrasound (QUS) parameters were significantly lower. On grouping patients according to their mean OPG levels, we observed significantly lower serum IGF-1, vitamin D3 concentrations, and lumbar spine and hip bone mineral density in the high OPG groups. No correlation was found between OPG and bone turnover markers, whereas a negative correlation was found between serum OPG and IGF-1 levels (r= - 0.64, p = 0.032). Serum iPTH concentrations were positively correlated with bone alkaline phosphatase (B-ALP) (r = 0.69, p = 0.038) and BGP (r = 0.92, p [ABSTRACT FROM AUTHOR]

Published
2005
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