Osteoporosis in the European Union : a compendium of country-specific reports
; ; et al
in Archives of Osteoporosis (2013), 8(137), 1-218
This report describes epidemiology, burden, and treatment of osteoporosis in each of the 27 countries of the European Union (EU27). INTRODUCTION: In 2010, 22 million women and 5.5 million men were ... [more ▼]
This report describes epidemiology, burden, and treatment of osteoporosis in each of the 27 countries of the European Union (EU27). INTRODUCTION: In 2010, 22 million women and 5.5 million men were estimated to have osteoporosis in the EU; and 3.5 million new fragility fractures were sustained, comprising 620,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures. The economic burden of incident and prior fragility fractures was estimated at euro 37 billion. Previous and incident fractures also accounted for 1,180,000 quality-adjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. The aim of this report was to characterize the burden of osteoporosis in each of the EU27 countries in 2010 and beyond. METHODS: The data on fracture incidence and costs of fractures in the EU27 were taken from a concurrent publication in this journal (Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden) and country specific information extracted. RESULTS: The clinical and economic burden of osteoporotic fractures in 2010 is given for each of the 27 countries of the EU. The costs are expected to increase on average by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. CONCLUSIONS: In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis has decreased in recent years, suggesting that a change in healthcare policy concerning the disease is warranted. [less ▲]Detailed reference viewed: 18 (2 ULg)
Strontium ranelate in the treatment of knee osteoarthritis: new insights and emerging clinical evidence.
REGINSTER, Jean-Yves ; Beaudart, Charlotte ; et al
in Therapeutic advances in musculoskeletal disease (2013), 5(5), 268-276
Osteoarthritis is a primary cause of disability and functional incapacity. Pharmacological treatment is currently limited to symptomatic management, and in advanced stages, surgery remains the only ... [more ▼]
Osteoarthritis is a primary cause of disability and functional incapacity. Pharmacological treatment is currently limited to symptomatic management, and in advanced stages, surgery remains the only solution. The therapeutic armamentarium for osteoarthritis remains poor in treatments with an effect on joint structure, that is, disease-modifying osteoarthritis drugs (DMOADs). Glucosamine sulfate and chondroitin sulfate are the only medications for which some conclusive evidence for a disease-modifying effect is available. Strontium ranelate is currently indicated for the prevention of fracture in severe osteoporosis. Its efficacy and safety as a DMOAD in knee osteoarthritis has recently been explored in the SEKOIA trial, a 3-year randomized, double-blind, placebo-controlled trial. Outpatients with knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) of 2.5-5 mm received strontium ranelate 1 g/day (n = 558) or 2 g/day (n = 566), or placebo (n = 559). This sizable population was aged 62.9 years and had a JSW of 3.50 +/- 0.84 mm. Treatment with strontium ranelate led to significantly less progression of knee osteoarthritis: estimates for annual difference in joint space narrowing versus placebo were 0.14 mm [95% confidence interval (CI) 0.05-0.23 mm; p < 0.001] for 1 g/day and 0.10 mm (95% CI 0.02-0.19 mm; p = 0.018) for 2 g/day, with no difference between strontium ranelate groups. Radiological progression was less frequent with strontium ranelate (22% with 1 g/day and 26% with 2 g/day versus 33% with placebo, both p < 0.05), as was radioclinical progression (8% and 7% versus 12%, both p < 0.05). Symptoms also improved with strontium ranelate 2 g/day only in terms of total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score (p = 0.045), and its components for pain (p = 0.028) and physical function (p = 0.099). Responder analyses using a range of criteria for symptoms indicated that the effect of strontium ranelate 2 g/day on pain and physical function was clinically meaningful. Strontium ranelate was well tolerated. The observation of both structure and symptom modification with strontium ranelate 2 g/day makes SEKOIA a milestone in osteoarthritis research and treatment. [less ▲]Detailed reference viewed: 22 (10 ULg)
What is the predictive value of MRI for the occurrence of knee replacement surgery in knee osteoarthritis?
; ; et al
in Annals of the Rheumatic Diseases (2013), 72(10), 1594-1604
Knee osteoarthritis is associated with structural changes in the joint. Despite its many drawbacks, radiography is the current standard for evaluating joint structure in trials of potential disease ... [more ▼]
Knee osteoarthritis is associated with structural changes in the joint. Despite its many drawbacks, radiography is the current standard for evaluating joint structure in trials of potential disease-modifying osteoarthritis drugs. MRI is a non-invasive alternative that provides comprehensive imaging of the whole joint. Frequently used MRI measurements in knee osteoarthritis are cartilage volume and thickness; others include synovitis, synovial fluid effusions, bone marrow lesions (BML) and meniscal damage. Joint replacement is considered a clinically relevant outcome in knee osteoarthritis; however, its utility in clinical trials is limited. An alternative is virtual knee replacement on the basis of symptoms and structural damage. MRI may prove to be a good alternative to radiography in definitions of knee replacement. One of the MRI parameters that predicts knee replacement is medial compartment cartilage volume/thickness, which correlates with radiographic joint space width, is sensitive to change, and predicts outcomes in a continuous manner. Other MRI parameters include BML and meniscal lesions. MRI appears to be a viable alternative to radiography for the evaluation of structural changes in knee osteoarthritis and prediction of joint replacement. [less ▲]Detailed reference viewed: 23 (4 ULg)
Value of biomarkers in osteoarthritis: current status and perspectives.
; ; et al
in Annals of the Rheumatic Diseases (2013), 72
Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint ... [more ▼]
Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint remodelling and disease progression. This article was prepared following a working meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis convened to discuss the value of biochemical markers of matrix metabolism in drug development in osteoarthritis. The best candidates are generally molecules or molecular fragments present in cartilage, bone or synovium and may be specific to one type of joint tissue or common to them all. Many currently investigated biomarkers are associated with collagen metabolism in cartilage or bone, or aggrecan metabolism in cartilage. Other biomarkers are related to non-collagenous proteins, inflammation and/or fibrosis. Biomarkers in osteoarthritis can be categorised using the burden of disease, investigative, prognostic, efficacy of intervention, diagnostic and safety classification. There are a number of promising candidates, notably urinary C-terminal telopeptide of collagen type II and serum cartilage oligomeric protein, although none is sufficiently discriminating to differentiate between individual patients and controls (diagnostic) or between patients with different disease severities (burden of disease), predict prognosis in individuals with or without osteoarthritis (prognostic) or perform so consistently that it could function as a surrogate outcome in clinical trials (efficacy of intervention). Future avenues for research include exploration of underlying mechanisms of disease and development of new biomarkers; technological development; the 'omics' (genomics, metabolomics, proteomics and lipidomics); design of aggregate scores combining a panel of biomarkers and/or imaging markers into single diagnostic algorithms; and investigation into the relationship between biomarkers and prognosis. [less ▲]Detailed reference viewed: 22 (7 ULg)
The effects of vitamin D on skeletal muscle strenght : a meta-analysis of randomized controlled trials
Beaudart, Charlotte ; Buckinx, Fanny ; Rabenda, Véronique et al
in European Geriatric Medicine (2013), 4(S1), 72Detailed reference viewed: 28 (9 ULg)
Impact of a 6-month training by whole body vibration on functional and motor abilities among nursing home residents observed over a 12-months period
Buckinx, Fanny ; Beaudart, Charlotte ; Demonceau, Marie et al
in European Geriatric Medicine (2013), 4(S1), 54-55Detailed reference viewed: 13 (6 ULg)
What are the clinical characteristics of patients improving their gait and body balance with whole body vibration ? Results of a 3-month randomized controlled trial
Beaudart, Charlotte ; Buckinx, Fanny ; Maquet, Didier et al
in European Geriatric Medicine (2013), 4(S1), 53Detailed reference viewed: 22 (8 ULg)
The Effect of 3 or 6 Years of Denosumab Exposure in Women With Postmenopausal Osteoporosis: Results From the FREEDOM Extension.
; ; et al
in The Journal of clinical endocrinology and metabolism (2013)
Context:The FREEDOM extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.Objective:Report results from the first 3 years of the extension, representing up to 6 years ... [more ▼]
Context:The FREEDOM extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.Objective:Report results from the first 3 years of the extension, representing up to 6 years of denosumab exposure.Design, Setting, and Participants: Multicenter, international, open-label study of 4550 women.Intervention:Women from the FREEDOM denosumab group received 3 more years of denosumab for a total of 6 years (long-term) and women from the FREEDOM placebo group received 3 years of denosumab (cross-over).Main Outcome Measures:Bone turnover markers (BTMs), bone mineral density (BMD), fracture, and safety.Results:Reductions in BTMs were maintained (long-term) or achieved rapidly (cross-over) following denosumab administration. In the long-term group, BMD further increased for cumulative 6-year gains of 15.2% (lumbar spine) and 7.5% (total hip). During the first 3 years of denosumab treatment, the cross-over group had significant gains in lumbar spine (9.4%) and total hip (4.8%) BMD, similar to the long-term group during the 3-year FREEDOM trial. In the long-term group, fracture incidences remained low and below rates projected for a "virtual placebo" cohort. In the cross-over group, 3-year incidences of new vertebral and nonvertebral fractures were similar to those of the FREEDOM denosumab group. Incidence rates of adverse events did not increase over time. Six participants had events of ONJ confirmed by adjudication. One participant had a fracture adjudicated as consistent with atypical femoral fracture.Conclusion:Denosumab treatment for 6 years remained well tolerated, maintained reduced bone turnover, and continued to increase BMD. Fracture incidence remained low. [less ▲]Detailed reference viewed: 28 (2 ULg)
Erratum to: Vitamin D Status and Bone Mineral Density Changes During Alendronate Treatment in Postmenopausal Osteoporosis.
; ; et al
in Calcified tissue international (2013)Detailed reference viewed: 12 (1 ULg)
Cost-effectiveness of denosumab in the treatment of postmenopausal osteoporotic women.
Hiligsmann, Mickaël ; ; et al
in Expert review of pharmacoeconomics & outcomes research (2013), 13(1), 19-28
Denosumab is a novel biological agent for the treatment of osteoporosis in postmenopausal women with increased risk of fractures. With limited healthcare resources, economic evaluations are increasingly ... [more ▼]
Denosumab is a novel biological agent for the treatment of osteoporosis in postmenopausal women with increased risk of fractures. With limited healthcare resources, economic evaluations are increasingly being used by decision-makers to optimize healthcare resource allocation. The cost-effectiveness of denosumab has been evaluated in various studies, and a systematic literature study was conducted up to April 2012 to identify all published research articles and research abstracts presented at various congresses. This article provides a systematic review of four articles and eight abstracts reporting on the cost-effectiveness of denosumab in the treatment of osteoporosis. In most economic evaluations, denosumab has been considered as a cost-effective treatment compared with first-line and second-line options (including generic alendronate) in the treatment of women with high risk of fractures. [less ▲]Detailed reference viewed: 19 (3 ULg)
Erratum to : Recommendations for the health economics analysis to be performed with a drug to be registered in prevention or treatment of osteoporosis
; ; et al
in Calcified Tissue International (2013), 93Detailed reference viewed: 23 (1 ULg)
What do we know about the safety of corticosteroids in rheumatoid arthritis?
Ethgen, Olivier ; De Lemos Esteves, Frédéric ; Bruyère, Olivier et al
in Current Medical Research & Opinion (2013), 29(9), 1147-60
Abstract Background: Clear information is still lacking on the safety of corticosteroids (GCs) therapy in RA despite six decades of clinical experience. Scope: We performed a literature search in Ovid ... [more ▼]
Abstract Background: Clear information is still lacking on the safety of corticosteroids (GCs) therapy in RA despite six decades of clinical experience. Scope: We performed a literature search in Ovid MEDLINE from January 2000 to December 2012. Our Population Intervention Comparator Outcomes (PICO) strategy search was: rheumatoid arthritis [Population], corticosteroids or glucocorticoids [Intervention], any comparison [Comparator], adverse effects [Outcome]. Studies were selected if they reported any measure of association between GCs intake and potential adverse effects in RA patients. Findings: We identified 1030 papers and selected for analysis 26 observational studies and six systematic reviews. The major side effects of GCs in RA are bone loss, risk of cardiovascular events and risk of infections as evidenced by large observational studies and not necessarily RCTs. Others associations were reported with herpes zoster, tuberculosis, hyperglycemia, cutaneous abnormalities, gastrointestinal perforation, respiratory infection and self-reported health problems such as cushingoid phenotype, ecchymosis, parchment-like skin, epistaxis, weight gain and sleep disturbance. Other potential adverse effects of GCs were studied but no association was found. These included psychological disorders, dermatophytosis, brain diseases, interstitial lung disease, memory deficit, metabolic syndrome, lymphoma, non-Hodgkin's lymphoma, renal function and cerebrovascular accidents. Most of the evidence emanates from observational researches and the inherent limitations of such data should be kept in mind. Conclusion: Recent observational data and systematic reviews suggest that GCs can lead to relatively alarming and burdensome side effects in RA. This is particularly true for patients who have longer term and higher dose therapies. GCs are largely used in RA and knowing their safety profile is essential to improve patients care. The design of new therapeutic strategies intended to minimize the daily dosing of GCs while conserving their beneficial effect should be encouraged. [less ▲]Detailed reference viewed: 33 (19 ULg)
Tools in the assessment of sarcopenia.
; ; et al
in Calcified Tissue International (2013), 93(3), 201-10
This review provides a framework for the development of an operational definition of sarcopenia and of the potential end points that might be adopted in clinical trials among older adults. While the ... [more ▼]
This review provides a framework for the development of an operational definition of sarcopenia and of the potential end points that might be adopted in clinical trials among older adults. While the clinical relevance of sarcopenia is widely recognized, there is currently no universally accepted definition of the disorder. The development of interventions to alter the natural history of sarcopenia also requires consensus on the most appropriate end points for determining outcomes of clinical importance which might be utilized in intervention studies. We review current approaches to the definition of sarcopenia and the methods used for the assessment of various aspects of physical function in older people. The potential end points of muscle mass, muscle strength, muscle power, and muscle fatigue, as well as the relationships between them, are explored with reference to the availability and practicality of the available methods for measuring these end points in clinical trials. Based on current evidence, none of the four potential outcomes in question is sufficiently comprehensive to recommend as a uniform single outcome in randomized clinical trials. We propose that sarcopenia may be optimally defined (for the purposes of clinical trial inclusion criteria as well as epidemiological studies) using a combination of measures of muscle mass and physical performance. The choice of outcome measures for clinical trials in sarcopenia is more difficult; co-primary outcomes, tailored to the specific intervention in question, may be the best way forward in this difficult but clinically important area. [less ▲]Detailed reference viewed: 19 (4 ULg)
Cost-effectiveness of bazedoxifene compared with raloxifene in the treatment of postmenopausal osteoporotic women.
Hiligsmann, Mickaël ; Ben Sedrine, Wafa ; REGINSTER, Jean-Yves
in Journal of Bone and Mineral Research (2013), 28(4), 807-15
Bazedoxifene is a novel selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis. In addition to the therapeutic value of a new agent, evaluation of the cost ... [more ▼]
Bazedoxifene is a novel selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis. In addition to the therapeutic value of a new agent, evaluation of the cost-effectiveness compared with relevant alternative treatment(s) is an important consideration to facilitate healthcare decision making. This study evaluated the cost-effectiveness of bazedoxifene compared with raloxifene for the treatment of postmenopausal women with osteoporosis. The cost-effectiveness of treatment for 3 years with bazedoxifene was compared with raloxifene using an updated version of a previously validated Markov microsimulation model. Analyses were conducted from a Belgian healthcare payer perspective and, the base-case population was women (aged 70 years) with bone mineral density T-score </= -2.5. The effects of bazedoxifene and raloxifene on fracture risk were derived from the 3-year results of a randomized, double-blind, placebo-controlled and active-controlled study, including postmenopausal women with osteoporosis. The cost-effectiveness analysis based on efficacy data from the overall clinical trial indicated that bazedoxifene and raloxifene were equally cost-effective. When the results were examined based on the subgroup analysis of women at higher risk of fractures, bazedoxifene was dominant (lower cost for higher effectiveness) compared with raloxifene in most of the simulations. Sensitivity analyses confirmed the robustness of the results, which were largely independent of starting age of treatment, fracture risk, cost, and disutility. In addition, when the cost of raloxifene was reduced by one-half or when incorporating the raloxifene effects on reducing breast cancer, bazedoxifene remained cost-effective, at a threshold of euro35,000 per quality-adjusted life-years gained, in 85% and 68% of the simulations, respectively. Under the assumption of improved antifracture efficacy of bazedoxifene over raloxifene in women with high risk of fractures, this study suggests that bazedoxifene can be considered cost-effective, and even dominant, when compared with raloxifene in the treatment of postmenopausal osteoporotic women. [less ▲]Detailed reference viewed: 19 (4 ULg)
Nutrition and bone health : turning beliefs into knowledge for healthy behaviour
; Reginster, Jean-Yves
in Osteoporosis International (2013), 24(1), 388-389Detailed reference viewed: 23 (3 ULg)
Inhibition of sclerostin with romosozumab in postmenopausal women with low BMD : phase 2 trial results
; ; et al
in Osteoporosis International (2013), 24(1), 38-39Detailed reference viewed: 103 (3 ULg)
Patients' preferences for osteoporosis drug therapy : a discrete choice experiment
Hiligsmann, Mickaël ; ; et al
in Osteoporosis International (2013), 24(1), 53Detailed reference viewed: 13 (3 ULg)
Pharmacological management : osteoporosis and osteoarthritis, similarities and differences
in Osteoporosis International (2013), 24(1), 75-76Detailed reference viewed: 5 (2 ULg)
The general approach to the patient with osteoarthritis : is a treatment algorithm feasible ?
in Osteoporosis International (2013), 24(1), 385Detailed reference viewed: 7 (2 ULg)
Strontium ranelate effect on knee osteoarthritis progression : a MRI analysis
; ; et al
in Osteoporosis International (2013), 24(1), 312-313Detailed reference viewed: 37 (3 ULg)