Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids.
; ; et al
in Rheumatology (Oxford, England) (2013), 52(6), 1058-69
Objective. Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine ... [more ▼]
Objective. Long-term glucocorticoid use is accompanied by rapid bone loss; however, early treatment with bisphosphonates prevents bone loss and reduces fracture risk. The aim of this study was to examine the effects of two bisphosphonates, i.v. zoledronic acid (ZOL) versus oral risedronate (RIS), on bone turnover markers (BTMs) in subjects with glucocorticoid-induced osteoporosis (GIO).Methods. Patients were randomly stratified according to the duration of pre-study glucocorticoid therapy [prevention subpopulation (ZOL, n = 144; RIS, n = 144) </=3 months, treatment subpopulation (ZOL, n = 272; RIS, n = 273) >3 months]. Changes in beta-C-terminal telopeptides of type 1 collagen (beta-CTx), N-terminal telopeptide of type I collagen (NTx), procollagen type 1 N-terminal propeptide (P1NP) and bone-specific alkaline phosphatase (BSAP) from baseline were measured on day 10 and months 3, 6 and 12.Results. At most time points, there were significantly greater reductions (P < 0.05) in the concentrations of serum beta-CTx, P1NP and BSAP and urine NTx in subjects on ZOL compared with RIS in both males and females of the treatment and prevention subpopulations. In pre- and post-menopausal women, there were significantly greater reductions in the concentrations of BTMs with ZOL compared with RIS. At 12 months, ZOL had significantly greater reductions compared with RIS (P < 0.05) for beta-CTx, P1NP, BSAP and NTx levels, independent of glucocorticoid dose.Conclusions. Once-yearly i.v. infusion of ZOL 5 mg was well tolerated in different subgroups of GIO patients. ZOL was non-inferior to RIS and even superior to RIS in the response of BTMs in GIO patients.Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT00100620. [less ▲]Detailed reference viewed: 13 (5 ULg)
Health Technology Assessment in Osteoporosis.
Hiligsmann, Mickaël ; ; et al
in 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: 19 (10 ULg)
Nécessité de nouveaux critères de remboursement pour traiter l'ostéoporose en Belgique
Bruyère, Olivier ; ; et al
in Ortho-Rhumato (2012), 10(5), 3Detailed reference viewed: 20 (3 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: 36 (8 ULg)
Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: Results of a five-year, randomized, placebo-controlled trial.
Reginster, Jean-Yves ; ; et al
in Arthritis and Rheumatism (2008), 58(6), 1687-95
OBJECTIVE: This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo ... [more ▼]
OBJECTIVE: This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. METHODS: A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. RESULTS: Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. CONCLUSION: Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years. [less ▲]Detailed reference viewed: 15 (2 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: 29 (4 ULg)
Evaluation of proposals of Belgian Social Security Institute for reimbursement of bone densitometry tests. Toward a cost-effective strategy for osteoporosis screening?
Ben Sedrine, Wafa ; Ethgen, Olivier ; et al
in Aging Clinical & Experimental Research (2004), 16(5), 413-419
BACKGROUND AND AIMS: The Belgian Social Security Institute (hereafter INAMI) proposes a list of conditions to be considered as a prerequisite for reimbursement of Bone Mineral Density (BMD) measurements ... [more ▼]
BACKGROUND AND AIMS: The Belgian Social Security Institute (hereafter INAMI) proposes a list of conditions to be considered as a prerequisite for reimbursement of Bone Mineral Density (BMD) measurements. The aim of this paper was to evaluate the diagnostic accuracy of the proposed criteria for identifying osteoporosis, and to gauge how useful they are for more rational application of densitometry tests. METHODS: 3748 Caucasian women aged at least 50 years old were recruited consecutively from an outpatient university center, from the database of which all relevant data corresponding to the INAMI list of clinical factors, as well as patients' age, weight and height, were collected. BMD measurements using dual X-ray absorptiometry were reported at the spine and hip regions. Diagnostic accuracy was evaluated through measures of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Additionally, from ROC analysis, benchmark values for age and body mass index were identified and then, used alone and in combination with the INAMI test, were applied to define various screening strategies. For each of them, associated costs per osteoporotic patient detected were estimated. Cost estimates refer only to the costs associated with the densitometric procedure from the perspective of the reimbursement health authorities. RESULTS: Applying INAMI criteria for detecting osteoporosis at any of the considered sites yielded sensitivity of 68.9%, specificity of 50.7%, PPV of 42.9% and NPV of 57.3%. Comparison of incremental costs per patient of the different strategies revealed that, with 67.1 Euros, the option of opening BMD coverage to women on the basis of the INAMI conditions would be more cost-effective than mass screening (90.1 Euros) or applying the age criterion alone (70.2 Euros). However, the BMI condition seems to act as a better indicator of risk than the INAMI criteria in those meeting the age condition (35.4 Euros). CONCLUSIONS: The accuracy of the INAMI proposal turns out to be quite unsatisfactory, and did not adequately cover the population at risk of osteoporosis. From a resource allocation perspective, the best strategy by far would be to recommend using concomitantly INAMI, age and BMI-selective criteria. Some adaptations could enhance the usefulness of the INAMI proposals as a selective approach for BMD referral and reimbursement. [less ▲]Detailed reference viewed: 24 (1 ULg)