Health Technology Assessment in Osteoporosis.Hiligsmann, Mickaël ; ; et alin Calcified Tissue International (2013) We review the various aspects of health technology assessment in osteoporosis, including epidemiology and burden of disease, and assessment of the cost-effectiveness of recent advances in the treatment of ... [more ▼] We review the various aspects of health technology assessment in osteoporosis, including epidemiology and burden of disease, and assessment of the cost-effectiveness of recent advances in the treatment of osteoporosis and the prevention of fracture, in the context of the allocation of health-care resources by decision makers in osteoporosis. This article was prepared on the basis of a symposium held by the Belgian Bone Club and the discussions surrounding that meeting and is based on a review and critical appraisal of the literature. Epidemiological studies confirm the immense burden of osteoporotic fractures for patients and society, with lifetime risks of any fracture of the hip, spine, and forearm of around 40 % for women and 13 % for men. The economic impact is also large; for example, Europe's six largest countries spent <euro>31 billion on osteoporotic fractures in 2010. Moreover, the burden is expected to increase in the future with demographic changes and increasing life expectancy. Recent advances in the management of osteoporosis include novel treatments, better fracture-risk assessment notably via fracture risk algorithms, and improved adherence to medication. Economic evaluation can inform decision makers in health care on the cost-effectiveness of the various interventions. Cost-effectiveness analyses suggest that the recent advances in the prevention and treatment of osteoporosis may constitute an efficient basis for the allocation of scarce health-care resources. In summary, health technology assessment is increasingly used in the field of osteoporosis and could be very useful to help decision makers efficiently allocate health-care resources. [less ▲] Detailed reference viewed: 5 (2 ULg) Nécessité de nouveaux critères de remboursement pour traiter l'ostéoporose en BelgiqueBruyère, Olivier ; ; et alin Ortho-Rhumato (2012), 10(5), 3 Detailed reference viewed: 18 (3 ULg) Assessment 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 ; ; et alin 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 ▲] Detailed reference viewed: 53 (27 ULg) Long-term efficacy and safety of strontium ranelate in postmenopausal osteoporotic women: results over 10 yearsReginster, Jean-Yves ; ; et alin Osteoporosis International (2011, March), 22(Suppl.1), 110-111 Detailed reference viewed: 32 (6 ULg) Antifracture efficacy and safety of once-yearly Zoledronic acid 5mg in men with osteoporosis: a prospective, randomized, controlled trial; ; et al in Osteoporosis International (2011, March), 22(Suppl.1), 112 Detailed reference viewed: 38 (1 ULg) Adverse reactions and drug-drug interactions in the management of women with postmenopausal osteoporosis.; Reginster, Jean-Yves ; et alin Calcified Tissue International (2011), 89(2), 91-104 The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review ... [more ▼] The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review is to explore the risk of adverse drug reactions and drug-drug interactions with treatments for postmenopausal osteoporosis. We reviewed evidence for adverse reactions from regulatory documents, randomized controlled trials, pharmacovigilance surveys, and case series. Bisphosphonates are associated with gastrointestinal effects, musculoskeletal pain, and acute-phase reactions, as well as, very rarely, atrial fibrillation, atypical fracture, delayed fracture healing, osteonecrosis of the jaw, hypersensitivity reactions, and renal impairment. Cutaneous effects and osteonecrosis of the jaw are of concern for denosumab (both very rare), though there are no pharmacovigilance data for this agent yet. The selective estrogen receptor modulators are associated with hot flushes, leg cramps, and, very rarely, venous thromboembolism and stroke. Strontium ranelate has been linked to hypersensitivity reactions and venous thromboembolism (both very rare) and teriparatide with headache, nausea, dizziness, and limb pain. The solidity of the evidence base depends on the frequency of the reaction, and causality is not always easy to establish for the very rare adverse reactions. Drug-drug interactions are rare. Osteoporosis treatments are generally safe and well tolerated, though they are associated with a few very rare serious adverse reactions. While these are a cause for concern, the risk should be weighed against the benefits of treatment itself, i.e., the prevention of osteoporotic fracture. [less ▲] Detailed reference viewed: 16 (5 ULg) Non-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club; ; et al in Osteoporosis International (2011), 22(11), 2769-88 This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip ... [more ▼] This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip protectors. Vertebroplasty is also briefly reviewed. Non-pharmacological management of osteoporosis is a broad concept. It must be viewed as an essential part of the prevention of fractures from childhood through adulthood and the old age. The topic also includes surgical procedures for the treatment of peripheral and vertebral fractures and the post-fracture rehabilitation. The present document is the result of a consensus, based on a systematic review and a critical appraisal of the literature. Diets deficient in calcium, proteins or vitamin D impair skeletal integrity. The effect of other nutriments is less clear, although an excessive consumption of sodium, caffeine, or fibres exerts negative effects on calcium balance. The deleterious effects of tobacco, excessive alcohol consumption and a low BMI are well accepted. Physical activity is of primary importance to reach optimal peak bone mass but, if numerous studies have shown the beneficial effects of various types of exercise on bone mass, fracture data as an endpoint are scanty. Fall prevention strategies are especially efficient in the community setting, but less evidence is available about their effectiveness in preventing fall-related injuries and fractures. The efficacy of hip protectors remains controversial. This is also true for vertebroplasty and kyphoplasty. Several randomized controlled studies had reported a short-term advantage of vertebroplasty over medical treatment for pain relief, but these findings have been questioned by recent sham-controlled randomized clinical studies. [less ▲] Detailed reference viewed: 97 (39 ULg) Ranélate de strontium : efficacité à long terme sur 10 ans chez les femmes ménopausées ostéoporotiquesReginster, Jean-Yves ; ; et alin Revue du Rhumatisme (2010, November), 77(Suppl.3), 99-100 Detailed reference viewed: 6 (0 ULg) Five years treatment with strontium ranelate reduces vertebral and nonvertebral fractures and increases the number and quality of remaining life-years in women over 80 years of age.; ; et al in BONE (2010), 46(4), 1038-42 INTRODUCTION: Longevity has resulted in a greater proportion of the population entering a time of life when increasing bone fragility and falls predispose to fractures, particularly nonvertebral fractures ... [more ▼] INTRODUCTION: Longevity has resulted in a greater proportion of the population entering a time of life when increasing bone fragility and falls predispose to fractures, particularly nonvertebral fractures. Women over 80 years of age constitute 10% of the population but contribute 30% of all fractures and 60% of all nonvertebral fractures. Despite this, few studies have examined antifracture efficacy of treatments in this high-risk group and none has provided evidence for benefits beyond 3 years. MATERIALS AND METHODS: To determine whether strontium ranelate reduces the risk of vertebral and nonvertebral fractures during 5 years, we analyzed a subgroup of 1489 female patients over 80 years of age (mean 83.5+/-3.0 years) with osteoporosis from the SOTI (spinal osteoporosis therapeutic intervention) and TROPOS (treatment of peripheral osteoporosis) studies randomized to strontium ranelate 2 g/d or placebo. All received a supplement of calcium plus vitamin D. RESULTS: By intention to treat, vertebral fracture risk was reduced by 31% (relative risk, RR=0.69; 95% confidence interval, CI 0.52-0.92), nonvertebral fracture risk by 27% (RR=0.73; 95% CI 0.57-0.95), major nonvertebral fracture risk by 33% (RR=0.67; 95% CI 0.50-0.89) and hip fracture risk by 24% (RR=0.76; 95% CI 0.50-1.15, not significant). Treatment was cost-saving as it decreased cost and increased QALYs and life-years. DISCUSSION: Strontium ranelate safely produced a significant reduction in vertebral and nonvertebral fracture risk during 5 years in postmenopausal women over 80 years of age and was cost saving. [less ▲] Detailed reference viewed: 11 (1 ULg) FRAX(r) and the assessment of fracture probability in men and women from Belgium.Reginster, Jean-Yves ; ; Hiligsmann, Mickaël et alin Osteoporosis International (2009, March), 20(Suppl.1), 38-39 Detailed reference viewed: 12 (1 ULg) Evidence-based guidelines for the use of biochemical markers of bone turnover in the selection and monitoring of bisphosphonate treatment in osteoporosis: a consensus document of the Belgian Bone Club.; ; et al in International Journal of Clinical Practice (2009), 63(1), 19-26 OBJECTIVES: To review the clinical value of bone turnover markers (BTM), to initiate and/or monitor anti-resorptive treatment for osteoporosis compared with bone mineral density (BMD) and to evaluate ... [more ▼] OBJECTIVES: To review the clinical value of bone turnover markers (BTM), to initiate and/or monitor anti-resorptive treatment for osteoporosis compared with bone mineral density (BMD) and to evaluate suitable BTM and changes in BTM levels for significance of treatment efficiency. METHODOLOGY: Consensus meeting generating guidelines for clinical practice after review and discussion of the randomised controlled trials or meta-analyses on the management of osteoporosis in postmenopausal women. RESULTS: Although the correlation between BMD and BTM is statistically significant, BTM cannot be used as predictive markers of BMD in an individual patient. Both are independent predictors of fracture risk, but BTM can only be used as an additional risk factor in the decision to treat. Current data do not support the use of BTM to select the optimal treatment. However, they can be used to monitor treatment efficiency before BMD changes can be evaluated. Early changes in BTM can be used to measure the clinical efficacy of an anti-resorptive treatment and to reinforce patient compliance. DISCUSSION: Determining a threshold of BTM reflecting an optimal long-term effect is not obvious. The objective should be the return to the premenopausal range and/or a decrease at least equal to the least significant change (30%). Preanalytical and analytical variability of BTM is an important limitation to their use. Serum C-terminal cross-linked telopeptide of type I collagen (CTX), procollagen 1 N terminal extension peptide and bone specific alkaline phosphatase (BSALP) appear to be the most suitable. Conclusion: Consensus regarding the use of BTM resulted in guidelines for clinical practice. BMD determines the indication to treat osteoporosis. BTM reflect treatment efficiency and can be used to motivate patients to persist with their medication. [less ▲] Detailed reference viewed: 32 (8 ULg) Rationalisation du remboursement des médicaments de l'ostéoporose : de la mesure isolée de la densité osseuse à l'intégration des facteurs cliniques de risque fracturaire. Validation de l'algorithme FRAX(r)Neuprez, Audrey ; ; et alin Revue du Rhumatisme (2009), 76 Detailed reference viewed: 15 (4 ULg) Utility audit of Belgian DXA centers; ; et al in Osteoporosis International (2008, April), 19(Suppl.1), 205 Detailed reference viewed: 4 (1 ULg) Heritability of blood concentrations of sex-steroids in relation to body composition in young adult male siblings.; ; et al in Clinical Endocrinology (2008), 69(1), 129-35 OBJECTIVE: Sex steroid concentrations in men are related to body composition and both are determined by genetic and environmental factors. This study investigates heritability estimates of sex steroid ... [more ▼] OBJECTIVE: Sex steroid concentrations in men are related to body composition and both are determined by genetic and environmental factors. This study investigates heritability estimates of sex steroid serum concentrations and body composition as well as the genetic and environmental components of their interrelation. PATIENTS: Six hundred and seventy-four men (25-45 years) were included in this study with 274 independent pairs of brothers. MEASUREMENTS: Body composition and regional fat mass estimates were determined using dual-energy X-ray absorptiometry. Serum testosterone (T), SHBG, oestradiol (E(2)) and LH levels were determined by immunoassay; free T and E(2) levels were calculated. RESULTS: Both sex steroid hormone concentrations and indices of body composition exhibited significant heritability estimates. Among sex steroid hormones, T had the highest heritability (h(2) = 0.65), followed by free T (h(2) = 0.54). A heritability of 0.73 was observed for SHBG; a heritability estimate of 0.83 was obtained for body weight. Significant genetic correlations were found between whole body fat mass and serum T (rho(G) = -0.46), free T (rho(G) = -0.27) and SHBG (rho(G) = -0.48) concentrations. No genetic relationship was observed between total (F) E(2) or LH concentrations, respectively, and body composition. CONCLUSION: Both sex steroid serum levels and body composition are under strong genetic control. Their interrelation is in part underlied by a genetic correlation, indicative of the action of shared genes. [less ▲] Detailed reference viewed: 28 (4 ULg) Strontium ranelate reduces the risk of vertebral fracture in patients with osteopenia; ; Reginster, Jean-Yves et alin Osteoporosis International (2006, June), 17(Suppl.2), 85 Detailed reference viewed: 3 (1 ULg) Strontium ranelate reduces the risk of fracture in elderly women with osteoporosis in the first year of treatment; ; et al in Osteoporosis International (2006, June), 17(Suppl.2), 85-86 Detailed reference viewed: 4 (2 ULg) Strontium ranelate reduces the risk of vertebral fracture in patients with osteopenia; ; Reginster, Jean-Yves et alin Osteoporosis International (2006, March), 17(Suppl.1), 50 Detailed reference viewed: 2 (0 ULg) Strontium ranelate reduces the risk of fracture in elderly women with osteoporosis in the first year of treatment; ; et al in Osteoporosis International (2006, March), 17(Suppl.1), 7 Detailed reference viewed: 4 (0 ULg) DXA-based assessment of male patients using standardized bone density values and a national reference database; ; et al in Osteoporosis International (2006, March), 17(Suppl.1), 54 Detailed reference viewed: 4 (1 ULg) One-year increase in hip (hip or femoral neck) bone mineral density pridicts long-term (3 years) decrease in vertebral fracture incidence in patients treated with strontium ranelateBruyère, Olivier ; ; et alin Osteoporosis International (2006, March), 17(Suppl.1), 96 Detailed reference viewed: 2 (0 ULg) |
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