Treatment of osteoporosis in men.; Reginster, Jean-Yves ; et alin BONE (2013), 53(1), 134-44 SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline ... [more ▼] SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline) are discussed. INTRODUCTION: Awareness of osteoporosis in men is improving, although it remains under-diagnosed and under-treated. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) workshop was convened to discuss osteoporosis in men and to provide a report by a panel of experts (the authors). METHODS: A debate with an expert panel on preselected topics was conducted. RESULTS AND CONCLUSIONS: Although additional fracture data are needed to endorse the clinical care of osteoporosis in men, consensus views were reached on diagnostic criteria and intervention thresholds. Empirical data in men display similarities with data acquired in women, despite pathophysiological differences, which may not be clinically relevant. Men should receive treatment at a similar 10-year fracture probability as in women. The design of mixed studies may reduce the lag between comparable treatments for osteoporosis in women becoming available in men. [less ▲] Detailed reference viewed: 3 (2 ULg) Strontium ranelate decreases the risk of hip fracture over 3 and 5 years in post menopausal women at high riskReginster, Jean-Yves ; ; et alin Annals of the Rheumatic Diseases (2008, June), 67(Suppl.II), 540 Detailed reference viewed: 9 (2 ULg) Strontium ranelate demonstrates efficacy against hip fracture over 3 and 5 years in postmenopausal women at high risk of hip fractureReginster, Jean-Yves ; ; et alin Osteoporosis International (2008, April), 19(Suppl.1), 26-27 Detailed reference viewed: 7 (1 ULg) Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in menReginster, Jean-Yves ; Abadie, Eric ; et alin Osteoporosis International (2006), 17(1), 1-7 Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer ... [more ▼] Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures. [less ▲] Detailed reference viewed: 28 (8 ULg) Relationship between changes in biochemical markers of bone turnover and BMD to predict vertebral fracture risk; Reginster, Jean-Yves ; et alin Journal of Bone and Mineral Research (2004), 19(3), 394-401 The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent ... [more ▼] The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent change in osteocalcin was determined to be a better predictor of vertebral fracture risk than BMD. Introduction: The association between baseline BMD and fracture risk is well understood. However, the relationship between changes in BMD and fracture risk is not well defined. It has previously been demonstrated that BMD change was a poor predictor of vertebral fracture risk in raloxifene-treated women, whereas bone turnover markers were significantly associated with fracture risk. In the current analysis, we explore the prediction of vertebral fracture risk using changes in both BMD and bone turnover. Materials and Methods: The Multiple Outcomes of Raloxifene Evaluation (MORE) trial was a randomized, placebo-controlled trial of 7705 women with osteoporosis treated with raloxifene 60 or 120 mg/day for 3 years. Markers of bone turnover were measured in one-third of the study population (n = 2503), and the present analyses include these women. Logistic regression models were constructed using one-year percent changes in BMD and bone turnover and relevant baseline demographics to predict the risk of vertebral fracture with pooled raloxifene therapy at 3 years. All covariates were standardized before modeling to facilitate direct comparisons between changes in BMD and bone turnover. Results and Conclusion: Prevalent vertebral fracture status (p < 0.0001), baseline lumbar spine BMD (p < 0.0001), and number of years postmenopausal (p = 0.0005) were independent predictors of fracture risk in raloxifene-treated patients. Therapy-by-change in femoral neck BMD (p = 0.02) and therapy-by-change in osteocalcin (OC; p = 0.01) were also significant for all treatment groups, indicating that changes in BMD and OC have different effects on fracture risk for the placebo and pooled raloxifene groups. The final model included significant baseline variables and change in OC (p = 0.01), whereas change in femoral neck BMD was not significant. After adjustment of each significant baseline variable, the percent change in OC was better able to predict the reduction in vertebral fracture risk than the percent change in femoral neck BMD in patients treated with raloxifene. [less ▲] Detailed reference viewed: 16 (0 ULg) Optimizing patient adherence and persistence in strontium ranelate phase 3 program using a short term run-in studyReginster, Jean-Yves ; ; et alin Osteoporosis International (2002, November), 13(Suppl.3), 35-36 Detailed reference viewed: 13 (2 ULg) Supplementation of calcium-vitamin D should be adapted according to the patients status in international phase 3 program on osteoporosisReginster, Jean-Yves ; ; et alin Osteoporosis International (2002, November), 13(Suppl.3), 35 Detailed reference viewed: 6 (0 ULg) A short-term run-in study can significantly contribute to increasing the quality of long-term osteoporosis trials. The strontium-ranelate phase 3 programReginster, Jean-Yves ; ; et alin Osteoporosis International (2002), 13(S1), 30 Detailed reference viewed: 5 (1 ULg) Calcium-vitamin D supplementation in clinical trials of osteoporosis should be titrated on the basis of pre-study assessmentsReginster, Jean-Yves ; ; et alin Osteoporosis International (2002), 13(S1), 24 Detailed reference viewed: 8 (3 ULg) |
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