References of "Reginster, Jean-Yves"
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See detailSevere prevalent vertebral fractures predict subsequent vertebral and nonvertebral fractures: a 3-year prospective study
Bruyère, Olivier ULg; Roux, Christian; Nicolet, Delphine ULg et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 361-362

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See detailAssessment of joint space narrowing in knee osteoarthritis has good long-term intercentre reproducibility when read in pairs with a semi-automated device
Gensburger, Deborah; DEROISY, Rita ULg; Arlot, Monique et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 247-248

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See detailRadiological and clinical profil of osteoarthritic patients undergoing of total joint replacement
Neuprez, Audrey ULg; François, Garance ULg; Bruyère, Olivier ULg et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 129-130

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See detailLong-term (3 years) reproducibility for the radiological assessment of knee osteoarthritis
DEROISY, Rita ULg; Bruyère, Olivier ULg; Gensburger, Deborah et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 219-220

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See detailAn economic evaluation of strontium ranelate for the treatment of male osteoporosis
Hiligsmann, Mickaël ULg; Ben Sedrine, Wafa ULg; Bruyère, Olivier ULg et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 305-306

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See detailCost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women
Hiligsmann, Mickaël ULg; Ben Sedrine, Wafa ULg; Bruyère, Olivier ULg et al

in Osteoporosis International (2012, March), 23(Suppl. 2), 312-313

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See detailFive years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension.
Papapoulos, S.; Chapurlat, R.; Libanati, C. et al

in Journal of Bone and Mineral Research (2012), 27(3), 694-701

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to ... [more ▼]

The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for treatment of postmenopausal women with osteoporosis. Participants who completed FREEDOM were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fractures rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a "virtual untreated twin" cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw (ONJ). Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. (c) 2011 American Society for Bone and Mineral Research. [less ▲]

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See detailAssessment of health claims in the field of bone: a view of the Group for the Respect of Ethics and Excellence in Science (GREES)
Bruyère, Olivier ULg; Rizzoli, René; Coxam, V. et al

in Osteoporosis International (2012), 23

Health claims for food products in Europe are permitted if the nutrient has been shown to have a beneficial nutritional or physiological effect. This paper defines health claims related to bone health and ... [more ▼]

Health claims for food products in Europe are permitted if the nutrient has been shown to have a beneficial nutritional or physiological effect. This paper defines health claims related to bone health and provides guidelines for the design and the methodology of clinical studies to support claims. [less ▲]

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See detailManagement of glucocorticoid-induced osteoporosis
Rizzoli, R.; Adachi, J. D.; Cooper, C. et al

in Calcified Tissue International (2012), 91(4), 225-243

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory ... [more ▼]

This review summarizes the available evidence-based data that form the basis for therapeutic intervention and covers the current status of glucocorticoid-induced osteoporosis (GIOP) management, regulatory requirements, and risk-assessment options. Glucocorticoids are known to cause bone loss and fractures, yet many patients receiving or initiating glucocorticoid therapy are not appropriately evaluated and treated. An European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis workshop was convened to discuss GIOP management and to provide a report by a panel of experts. An expert panel reviewed the available studies that discussed approved therapeutic agents, focusing on randomized and controlled clinical trials reporting on bone mineral density and/or fracture risk of at least 48 weeks' duration. There is no evidence that GIOP and postmenopausal osteoporosis respond differently to treatments. The FRAX algorithm can be adjusted according to glucocorticoid dose. Available antiosteoporotic therapies such as bisphosphonates and teriparatide are efficacious in GIOP management. Several other agents approved for the treatment of postmenopausal osteoporosis may become available for GIOP. It is advised to stop antiosteoporotic treatment after glucocorticoid cessation, unless the patient remains at increased risk of fracture. Calcium and vitamin D supplementation as an osteoporosis-prevention measure is less effective than specific antiosteoporotic treatment. Fracture end-point studies and additional studies investigating specific subpopulations (pediatric, premenopausal, or elderly patients) would strengthen the evidence base and facilitate the development of intervention thresholds and treatment guidelines. © Springer Science+Business Media, LLC 2012. [less ▲]

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See detailEffet structuro-modulateur du ranélate de strontium dans la gonarthrose : l'étude SEKOIA
Chevalier, X; Chapurlat, R; Cooper, C et al

in Revue du Rhumatisme (2012), 79(S1), 271

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See detailQuelles sont les caractéristiques des médicaments les plus importantes pour les patients ostéoporotiques ? Résultats d'une étude qualitative
Hiligsmann, Mickaël ULg; Van Durme, C; Geusens, P et al

in Revue du Rhumatisme (2012), 79(S1), 238

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See detailLe ranélate de strontium diminue le nombre de progresseurs radiologiques ou radiocliniques chez les patients ayant une arthrose primaire du genou
Chevalier, X; Chapurlat, R; Cooper, C et al

in Revue du Rhumatisme (2012), 79(S1), 270

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See detailThe clinical and economic burden of poor adherence and persistence with osteoporosis medications in Ireland.
Hiligsmann, Mickaël ULg; McGowan, Bernie; Bennett, Kathleen et al

in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research (2012), 15(5), 604-12

OBJECTIVES: Medication nonadherence is common for osteoporosis, but its consequences have not been well described. This study aimed to quantify the clinical and economic impacts of poor adherence and to ... [more ▼]

OBJECTIVES: Medication nonadherence is common for osteoporosis, but its consequences have not been well described. This study aimed to quantify the clinical and economic impacts of poor adherence and to evaluate the potential cost-effectiveness of improving patient adherence by using hypothetical behavioral interventions. METHODS: A previously validated Markov microsimulation model was adapted to the Irish setting to estimate lifetime costs and outcomes (fractures and quality-adjusted life-year [QALY]) for three adherence scenarios: no treatment, real-world adherence, and full adherence over 3 years. The real-world scenario employed adherence and persistence data from the Irish Health Services Executive-Primary Care Reimbursement Services pharmacy claims database. We also investigated the cost-effectiveness of hypothetical behavioral interventions to improve medication adherence (according to their cost and effect on adherence). RESULTS: The number of fractures prevented and the QALY gain obtained at real-world adherence levels represented only 57% and 56% of those expected with full adherence, respectively. The costs per QALY gained of real-world adherence and of full adherence compared with no treatment were estimated at euro 11,834 and euro 6,341, respectively. An intervention to improve adherence by 25% would result in an incremental cost-effectiveness ratio of euro 11,511 per QALY and euro 54,182 per QALY, compared with real-world adherence, if the intervention cost an additional euro 50 and euro 100 per year, respectively. DISCUSSION: Poor adherence with osteoporosis medications results in around a 50% reduction in the potential benefits observed in clinical trials and a doubling of the cost per QALY gained from these medications. Depending on their costs and outcomes, programs to improve adherence have the potential to be an efficient use of resources. [less ▲]

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See detailExtraskeletal benefits and risks of calcium, vitamin D and anti-osteoporosis medications.
Body, J.-J.; Bergmann, P.; Boonen, S. et al

in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (2012), 23 Suppl 1

Drugs used for the prevention and the treatment of osteoporosis exert various favourable and unfavourable extra-skeletal effects whose importance is increasingly recognized notably for treatment selection ... [more ▼]

Drugs used for the prevention and the treatment of osteoporosis exert various favourable and unfavourable extra-skeletal effects whose importance is increasingly recognized notably for treatment selection. INTRODUCTION: The therapeutic armamentarium for the prevention and the treatment of osteoporosis is increasingly large, and possible extra-skeletal effects of available drugs could influence the choice of a particular compound. METHODS: The present document is the result of a national consensus, based on a systematic and critical review of the literature. RESULTS: Observational research has suggested an inverse relationship between calcium intake and cardiovascular diseases, notably through an effect on blood pressure, but recent data suggest a possible deleterious effect of calcium supplements on cardiovascular risk. Many diverse studies have implicated vitamin D in the pathogenesis of clinically important non-skeletal functions or diseases, especially muscle function, cardiovascular disease, autoimmune diseases and common cancers. The possible effects of oral or intravenous bisphosphonates are well-known. They have been associated with an increased risk of oesophageal cancer or atrial fibrillation, but large-scale studies have not found any association with bisphosphonate use. Selective oestrogen receptor modulators have demonstrated favourable or unfavourable extra-skeletal effects that vary between compounds. Strontium ranelate has a limited number of non-skeletal effects. A reported increase in the risk of venous thromboembolism is not found in observational studies, and very rare cases of cutaneous hypersensitivity reactions have been reported. Denosumab has been introduced recently, and its extra-skeletal effects still have to be assessed. CONCLUSION: Several non-skeletal effects of bone drugs are well demonstrated and influence treatment choices. [less ▲]

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See detailFracture risk and zoledronic acid therapy in men with osteoporosis
Boonen, S.; REGINSTER, Jean-Yves ULg; Kaufman, J.-M. et al

in New England Journal of Medicine (2012), 367(18), 1714-1723

BACKGROUND: Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk ... [more ▼]

BACKGROUND: Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk among men with osteoporosis. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of zoledronic acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months. RESULTS: The rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P = 0.002). As compared with men who received placebo, men who received zoledronic acid had fewer moderate-to-severe vertebral fractures (P = 0.03) and less height loss (P = 0.002). Fewer participants who received zoledronic acid had clinical vertebral or nonvertebral fractures, although this difference did not reach significance because of the small number of fractures. Bone mineral density was higher and bone-turnover markers were lower in the men who received zoledronic acid (P<0.05 for both comparisons). Results were similar in men with low serum levels of total testosterone. The zoledronic acid and placebo groups did not differ significantly with respect to the incidence of death (2.6% and 2.9%, respectively) or serious adverse events (25.3% and 25.2%). CONCLUSIONS: Zoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.) Copyright © 2012 Massachusetts Medical Society. [less ▲]

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See detailA randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density
Orwoll, E.; Teglbjærg, C. S.; Langdahl, B. L. et al

in Journal of Clinical Endocrinology and Metabolism (2012), 97(9), 3161-3169

Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of ... [more ▼]

Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P≥0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P < 0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed. Copyright © 2012 by The Endocrine Society. [less ▲]

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