Highest prevalence of vitamin D inadequacy in institutionalized women compared with noninstitutionalized women: a case-control study.
Bruyère, Olivier ; ; et al
in Women's Health (2009), 5(1), 49-54
The reduced capacity of older skin to synthesize vitamin D(3) under the influence of ultraviolet light makes older persons at risk of vitamin D deficiency. The risk could even be increased in ... [more ▼]
The reduced capacity of older skin to synthesize vitamin D(3) under the influence of ultraviolet light makes older persons at risk of vitamin D deficiency. The risk could even be increased in institutionalized persons owing to their lower sunshine exposure. It has been reported that an inadequate vitamin D level is associated with secondary hyperparathyroidism, increased bone turnover, and bone loss, which increase fracture risk. The objective of this study was to assess the prevalence of inadequate serum vitamin D levels in institutionalized, postmenopausal, osteoporotic women. Assessment of 25-hydroxyvitamin D [25(OH)D] was performed in 445 institutionalized, osteoporotic women from nine countries (Australia, Belgium, France, Germany, Hungary, Italy, Poland, Spain and UK). For each institutionalized woman, three age-matched, noninstitutionalized, osteoporotic controls were also included. Four cutoffs of 25(OH)D inadequacy were fixed: less than 80, less than 75, less than 50 and less than 30 nmol/l. Mean age was 79.7 years (standard deviation [SD] = 5.8) for the institutionalized women and 79.5 years (SD = 5.5) for the noninstitutionalized women (p = 0.45). Significantly fewer institutionalized women received vitamin D supplements (13.2 vs 24.0%; p < 0.0001). In women without vitamin D supplements, the level of 25(OH)D was significantly lower in institutionalized women (56.9 [SD = 23.9] nmol/l) compared with noninstitutionalized women (63.2 [SD = 22.0] nmol/l; p < 0.0001). In institutionalized women (without vitamin D supplements), the prevalence of 25(OH)D inadequacy was 10.4, 41.2, 80.3 and 84.2% when considering cutoffs of 80, 75, 50 and 30 nmol/l, respectively. In the control group, the prevalence was 2.7, 22.9, 74.4 and 81.7%, respectively. The prevalence of vitamin D inadequacy was significantly higher in institutionalized women when considering the 75, 50 and 30 nmol/l cutoffs but not when considering the 80 nmol/l cutoff. This study highlights a high prevalence of vitamin D inadequacy in institutionalized, osteoporotic women. Compared with age-matched osteoporotic controls, the prevalence of severe vitamin D inadequacy was substantially more important in institutionalized women. We believe that a greater awareness of the importance of vitamin D inadequacy is needed in order to address this public health problem. [less ▲]Detailed reference viewed: 54 (11 ULg)
Ibandronate in the management of postmenopausal osteoporosis
Reginster, Jean-Yves ; Hiligsmann, Mickaël ; Rabenda, Véronique et al
in Clinical Medicine. Therapeutics (2009), 1Detailed reference viewed: 33 (10 ULg)
Efficacite anti-fracturaire de l'ibandronate administre par voie intraveineuse: de la complexite des etudes epidemiologiques interventionnelles a la pratique quotidienne.
; Hiligsmann, Mickaël ; Bruyère, Olivier et al
in Revue Médicale de Liège (2009), 64(10), 525-9
Numerous epidemiological approaches are used to demonstrate the efficacy of a new chemical entity. In postmenopausal osteoporosis, anti-fracture efficacy can be assessed through prospective, randomized ... [more ▼]
Numerous epidemiological approaches are used to demonstrate the efficacy of a new chemical entity. In postmenopausal osteoporosis, anti-fracture efficacy can be assessed through prospective, randomized controlled trials, meta-analyses or real-life setting studies. Intravenous ibandronate was recently marketed, with the aim of optimizing drug absorption and adherence to treatment. Furthermore, this new formulation avoids gastrointestinal side effects and constrains linked to the oral intake of the medication. Spinal anti-fracture efficacy of IV ibandronate derives from a non-inferiority bridging study, using surrogate endpoints, i.e., bone mineral density and biochemical markers of bone turnover, compared to the oral daily formulation, previously registered for the treatment of osteoporosis in Europe. Coherent results from two separate meta-analyses have suggested that the non-vertebral anti-fracture efficacy of IV ibandronate is similar to that observed with oral, daily and weekly bisphosphonates. Similarly, a recent real-life setting study, based on claims from an US database, suggests that hip fractures are reduced, with IV ibandronate, to the same extend as they are with oral bisphosphonates. Notwithstanding, those results should probably be confirmed in an European setting, before being extrapolated, in daily practice, to the Belgian population. [less ▲]Detailed reference viewed: 25 (3 ULg)
Une prise orale unique (1200 mg) de sulfate de chondroïtine 4 & 6 (CS) réduit la douleur et améliore la fonction. Résultats d'une étude en double insu, contre placebo et un comparateur actif, chez des patients souffrants de gonarthrose (OA)
ZEGELS, Brigitte ; ; et al
in Revue du Rhumatisme (2009), 76Detailed reference viewed: 9 (4 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)
Modelling the uptake and diffusion of innovative technology: a critical and strategic feature of budget impact analysis and risk-sharing agreements.
Ethgen, Olivier ; Hiligsmann, Mickaël ; Reginster, Jean-Yves
in Value in Health (2009)Detailed reference viewed: 34 (8 ULg)
L'efficacité de l'ibandronate oral mensuel est maintenue sur 5 ans : l'étude MOBILE extension long terme (ELT)
; ; Reginster, Jean-Yves
in Revue du Rhumatisme (2009)Detailed reference viewed: 7 (2 ULg)
Strontium ranelate in the therapeutic strategies for osteoporosis, including glucocorticoid-induced osteoporosis (GIO)
in Bone (2009)Detailed reference viewed: 14 (3 ULg)
Effect of a single i.v. infusion of zoledronic acid on bone turnover markers versus oral risedronate in patients with glucocorticoid-induced osteoporosis.
; ; Reginster, Jean-Yves et al
in Bone (2009)Detailed reference viewed: 8 (1 ULg)
Efficacy and safety of piroxicam revisited. A global meta-analysis of randomised clinical trials.
; ; et al
in Pharmacological Research (2009), 60
BACKGROUND: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a ... [more ▼]
BACKGROUND: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a widely used NSAID, a meta-analysis of comparative RCTs was carried out according to the QUOROM guidance. METHODS: A systematic comprehensive research (years 1980-2006) of any comparative randomised controlled trial (of over 7-day duration) with piroxicam for the treatment of osteoarticular conditions was conducted. Conservative analyses were stratified by comparator, outcome, indication, duration, and doses. Publication bias and robustness were exhaustively investigated. RESULTS: Seventy-five comparative trials were ultimately included for analyses. Regarding global efficacy, piroxicam was more effective than naproxen [OR=1.37 (1.05; 1.77)] and nabumetone [OR=1.72 (1.26; 2.34)], while equivalent to other NSAIDS [OR=1.06 (0.96; 1.18)]. For pain and articular swelling, piroxicam was statistically equivalent to all other NSAIDs. For mobility, piroxicam appeared to be more effective than indomethacin, while equivalent to all other NSAIDs. Piroxicam was globally safer than other NSAIDs OR=0.84 [0.73; 0.96], notably indomethacin [OR=0.53 (0.43; 0.64], naproxen [OR=0.75 (0.65; 0.85)] and salicylates [OR=0.36 (0.17; 0.75)]. From a global GI safety point of view, piroxicam was better tolerated than indomethacin [OR=0.46 (0.36; 0.58)], naproxen [OR=0.66 (0.53; 0.83)] and salicylates [OR=0.45 (0.27; 0.78)] while less tolerated when compared to meloxicam [OR=1.49 (1.05; 2.13)]. Major GI effects were comparable among piroxicam users as in comparator drugs users [OR=1.33 (0.96; 1.84)], except for meloxicam [OR=2.37 (1.13; 4.97)]. The skin safety of piroxicam was statistically comparable to those of comparators [OR=1.01 (0.68; 1.51)]. CONCLUSION: This meta-analysis of RCTs support a similar to more favourable efficacy/safety profile of piroxicam as compared to other t-NSAIDs. [less ▲]Detailed reference viewed: 68 (7 ULg)
Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis.
; ; et al
in Osteoporosis International (2009), 20
Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33 ... [more ▼]
Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33% over 4 years, confirming the role of strontium ranelate as an effective long-term treatment in osteoporosis. INTRODUCTION: Osteoporotic vertebral fractures are associated with increased mortality, morbidity, and loss of quality-of-life (QoL). Strontium ranelate (2 g/day) was shown to prevent bone loss, increase bone strength, and reduce vertebral and peripheral fractures. The preplanned aim of this study was to evaluate long-term efficacy and safety of strontium ranelate. METHODS: A total of 1,649 postmenopausal osteoporotic women were randomized to strontium ranelate or placebo for 4 years, followed by a 1-year treatment-switch period for half of the patients. Primary efficacy criterion was incidence of patients with new vertebral fractures over 4 years. Lumbar bone mineral density (BMD) and QoL were also evaluated. RESULTS: Over 4 years, risk of vertebral fracture was reduced by 33% with strontium ranelate (risk reduction = 0.67, p < 0.001). Among patients with two or more prevalent vertebral fractures, risk reduction was 36% (p < 0.001). QoL, assessed by the QUALIOST(R), was significantly better (p = 0.025), and patients without back pain were greater (p = 0.005) with strontium ranelate than placebo over 4 years. Lumbar BMD increased over 5 years in patients who continued with strontium ranelate, while it decreased in patients who switched to placebo. Emergent adverse events were similar between groups. CONCLUSION: In this 4- and 5-year study, strontium ranelate is an effective and safe treatment for long-term treatment of osteoporosis in postmenopausal women. [less ▲]Detailed reference viewed: 44 (11 ULg)
Effets du sulfate de chondroitine sur les indices d'utilité de santé chez des sujets gonarthrosiques et analyses économiques préliminaires.
Bruyère, Olivier ; ; Neuprez, Audrey et al
in Revue du Rhumatisme (2009), 76Detailed reference viewed: 19 (4 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 al
in Revue du Rhumatisme (2009), 76Detailed reference viewed: 15 (4 ULg)
Analyses coût-efficacité du sulfate de glucosamine chez des patients gonarthrosiques : comparaison avec le paracétamol.
Bruyère, Olivier ; ; Neuprez, Audrey et al
in Revue du Rhumatisme (2009), 76Detailed reference viewed: 29 (1 ULg)
Relations entre les variations de densité minérale osseuse et l'incidence des fractures vertébrales: analyse des 3 dernières années d'un traitement de 8 ans sous ranélate de strontium.
Bruyère, Olivier ; Detilleux, Johann ; et al
in Revue du Rhumatisme (2009), 76Detailed reference viewed: 11 (1 ULg)
Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence.
Rabenda, Véronique ; Hiligsmann, Mickaël ; Reginster, Jean-Yves
in Expert Opinion on Pharmacotherapy (2009), 10(14), 2303-15
Poor therapeutic adherence is a major issue faced by physicians today. This paper summarizes the adherence rates with oral bisphosphonate (OBP) treatment in clinical practice and their impact on clinical ... [more ▼]
Poor therapeutic adherence is a major issue faced by physicians today. This paper summarizes the adherence rates with oral bisphosphonate (OBP) treatment in clinical practice and their impact on clinical outcomes. Studies systematically demonstrated that overall compliance and persistence with OBPs among osteoporotic women are poor. Although extending dosing intervals improved adherence, the gains are suboptimal. Most importantly, low compliance and persistence rates consistently resulted in increased rates of fractures. The results emphasize the importance of adherence to treatment to achieve optimal antifracture efficacy. There is an urgent need to implement strategies and to encourage physicians to take measures that increase patients' awareness of the need to use osteoporosis medications as directed in order to benefit from them fully. [less ▲]Detailed reference viewed: 57 (7 ULg)
Low dietary intake calcium in European postmenopausal osteoporotic women
Bruyère, Olivier ; ; et al
in Public Health Nutrition (2009), 12(1), 111-114
Objective The WHO recommends a daily Ca intake for postmenopausal women of 1300 mg. The objective of the present study was to assess the dietary Ca intake in European postmenopausal osteoporotic women ... [more ▼]
Objective The WHO recommends a daily Ca intake for postmenopausal women of 1300 mg. The objective of the present study was to assess the dietary Ca intake in European postmenopausal osteoporotic women. Design, setting and subjects Assessment of dietary Ca intake (food and supplements) was performed with a validated self-questionnaire in 8524 osteoporotic women from nine European countries (Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Spain and the UK). Results Mean age of the patients was 74·2 (sd 7·1) years, mean BMI was 25·7 (sd 4·2) kg/m2. Of the study population, 37·2 % of the women took Ca supplements. The mean dietary intake of Ca was 930·7 (sd 422·9) mg/d. The lowest Ca intake was found in Hungary (586·7 (sd 319·1) mg/d) and the highest in Denmark (1145·6 (sd 463·0) mg/d). In the whole study population, only 19·1 % of the women had a dietary Ca intake >1300 mg/d. Only 17·1 % of women aged over 75 years achieved 1300 mg/d compared with 20·5 % of women aged less than 75 years (P = 0·0001 for the difference between the two groups). Conclusion Dietary intake of Ca is very low in European postmenopausal women. A greater awareness is needed to resolve this public health problem. [less ▲]Detailed reference viewed: 62 (29 ULg)
Management of osteoporosis in the elderly.
; Bruyère, Olivier ; et al
in Current Medical Research & Opinion (2009), 25(10), 2373-2387
ABSTRACT Background: Osteoporosis is predominantly a condition of the elderly, and the median age for hip fracture in women is approximately 83 years. Osteoporotic fracture risk is multifactorial, and ... [more ▼]
ABSTRACT Background: Osteoporosis is predominantly a condition of the elderly, and the median age for hip fracture in women is approximately 83 years. Osteoporotic fracture risk is multifactorial, and often involves the balance between bone strength and propensity for falling. Objective: To present an overview of the available evidence, located primarily by Medline searches up to April, 2009, for the different management strategies aimed at reducing the risk of falls and osteoporotic fractures in the elderly. Results: Frailty is an independent predictor of falls, hip fractures, hospitalisation, disability and death in the elderly that is receiving increasing attention. Non-pharmacological strategies to reduce fall risk can prevent osteoporotic fractures. Exercise programmes, especially those involving high doses of exercise and incorporating balance training, have been shown to be effective. Many older people, especially the very elderly and those living in care institutions, have vitamin D inadequacy. In appropriate patients and given in sufficient doses, vitamin D and calcium supplementation is effective in reducing both falls and osteoporotic fractures, including hip fractures. Specific anti-osteoporosis drugs are underused, even in those most at risk of osteoporotic fracture. The evidence base for the efficacy of most such drugs in the elderly is incomplete, particularly with regard to nonvertebral and hip fractures. The evidence base is perhaps most complete for the relatively recently introduced drug, strontium ranelate. Non-adherence to treatment is a substantial problem, and may be exacerbated by the requirements for safe oral administration of bisphosphonates. Conclusion: Evidence-based strategies are available for reducing osteoporotic fracture risk in the elderly, and include exercise training, vitamin D and calcium supplementation, and use of evidence-based anti-osteoporotic drugs. A positive and determined approach to optimising the use of such strategies could reduce the burden of osteoporotic fractures in this high-risk group. [less ▲]Detailed reference viewed: 74 (6 ULg)
Long-term treatment of postmenopausal osteoporosis with strontium ranelate: Results at 8 years.
Reginster, Jean-Yves ; Bruyère, Olivier ; et al
in BONE (2009), 45
OBJECTIVES: Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This ... [more ▼]
OBJECTIVES: Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This article describes the efficacy, safety, and tolerability of this agent over 8 years. METHODS: Postmenopausal osteoporotic women having participated in the 5-year efficacy trials SOTI and TROPOS were invited to enter a 3-year open-label extension study. The results presented here focus on patients who received strontium ranelate for 8 years. RESULTS: At the extension baseline, the population treated for 8 years (n=879; 79.1+/-5.6 years) had femoral neck T-score of -2.61+/-0.71. The cumulative incidences of new vertebral and nonvertebral fractures (13.7% and 12.0%, respectively) over years 6 to 8 were non-statistically different from the cumulative incidences in the first 3 years of the original studies (11.5% and 9.6%). Lumbar spine, femoral neck, and total hip bone mineral density (BMD) increased throughout the 8-year period. Annual relative change in BMD was significant at every visit, except the 8-year visit for femoral neck and total hip BMD. Strontium ranelate was safe and well tolerated over 8 years. CONCLUSIONS: Long-term treatment with strontium ranelate 2 g/day in postmenopausal osteoporotic women leads to continued increases in BMD at all sites. The data also provide some evidence for a sustained antifracture efficacy. [less ▲]Detailed reference viewed: 79 (31 ULg)
Impact of chondroitin sulphate on health utility in patients with knee osteoarthritis: towards economic analysis.
Bruyère, Olivier ; ; et al
in Journal of Medical Economics (2009), 12(4), 356-360
Abstract Objectives: The first objective was to assess the effect of the chondroitin 4 and 6 sulphate (CS) on health-related quality of life using utility values in patients with knee osteoarthritis (OA ... [more ▼]
Abstract Objectives: The first objective was to assess the effect of the chondroitin 4 and 6 sulphate (CS) on health-related quality of life using utility values in patients with knee osteoarthritis (OA) during a 24-month treatment course. The second objective was, using these data, to conduct economic analyses. Methods: Data from the STOPP study was used. This study was a randomised, double-blind, placebo (PL) -controlled trial of 2-year duration. In the STOPP study, authors assessed quality of life using the Western Ontario and McMaster Osteoarthritis Index (WOMAC). WOMAC scores were translated into Health Utility Index (HUI) scores using a specific formula. Incremental cost effectiveness ratio (ICER) was calculated taking into account the cost of CS and its effect on HUI scores, compared to PL. Results: At baseline, the mean (SD) HUI scores were 0.59 (0.17), and 0.59 (0.18) for the PL and CS groups, respectively (p=0.31 between the two groups). The mean (SD) HUI scores changes from baseline to 6 months were 0.02 (0.02), and 0.05 (0.01) for the PL and CS groups, respectively (p=0.03). After 24 months of follow-up, HUI score increases by 0.04 (0.02) in the PL group and by 0.05 (0.02) in the CS group (p=0.37). Using the price bracket of CS in Europe, ICER assessment always resulted in a cost below euro30,000 per QALY gained, after 6, 12 and 24 months of treatment. Conclusion: CS treatment increases health utilities in patients with knee OA compared to PL over the first 6 months of treatment. Economic evaluation based on these data suggests that CS treatment could be considered as cost-effective in patients with knee OA up to a period of 24 months. A limitation in this study is the absence of direct utility assessment as well as the absence of effective treatment as comparator. [less ▲]Detailed reference viewed: 50 (16 ULg)