References of "REGINSTER, Jean-Yves"
     in
Bookmark and Share    
Full Text
Peer Reviewed
See detailEtoricoxib demonstrates similar efficacy and improved gastrointestinal safety compared to naproxen in two 138-week randomized studies of osteoarthritis patients
Reginster, Jean-Yves ULg; Fischer, C. L.; Beualieu, A. et al

in Annals of the Rheumatic Diseases (2004, June)

Detailed reference viewed: 21 (1 ULg)
Full Text
Peer Reviewed
See detailClinical utility of a pharmacostatistical model for ibandronate in osteoporosis
Gieschke, R.; Reginster, Jean-Yves ULg

in Annals of the Rheumatic Diseases (2004, June)

Detailed reference viewed: 10 (1 ULg)
Full Text
Peer Reviewed
See detailA novel bisphosphonate dosing regimen: once-monthly oral ibandronate
Cooper, C.; Adami, Silvio; Stepan, J. J. et al

in Annals of the Rheumatic Diseases (2004, June)

Detailed reference viewed: 8 (1 ULg)
Full Text
Peer Reviewed
See detailPrevention of postmenopausal osteoporosis with pharmacological therapy: practice and possibilities
Reginster, Jean-Yves ULg

in Journal of Internal Medicine (2004), 255(6), 615-628

Postmenopausal osteoporosis (PMO) is a common disease that will become more prevalent in the future, with costly implications for public health. Prevention of the disease and its consequences, namely ... [more ▼]

Postmenopausal osteoporosis (PMO) is a common disease that will become more prevalent in the future, with costly implications for public health. Prevention of the disease and its consequences, namely fractures, is therefore, important for both the individual and society. This review discusses: the goals of PMO prevention; the identification of women at risk, including the use of bone mineral density and bone turnover markers; the relevance in the prevention setting of various current guidelines for PMO management; recent data on therapeutic options for the treatment and prevention of PMO, in particular bisphosphonates, hormone replacement therapy and several other new pharmacological agents. It concludes that it is crucial for PMO prevention to start before disease onset and that, in the light of recent evidence, the existing guidelines need updating if they are to continue to be relevant. [less ▲]

Detailed reference viewed: 17 (0 ULg)
Full Text
Peer Reviewed
See detailSummary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma
Holgate, S. T.; Bousquet, J.; Chung, K. F. et al

in Respiratory Medicine (2004), 98(6), 479-487

With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom ... [more ▼]

With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom preventers and disease modifying agents. Attention is drawn to the types of experimental evidence required in preclinical studies to support further clinical development of a new therapy. Clinical trials demand careful selection of patients to maximise the strength of the efficacy signal according to the type of trial being designed. While provocation tests are useful in suggesting efficacy, negative tests do not necessarily indicate lack of anti-asthma activity. Therapeutic trial designs need to take account of duration of treatment, dose-response relationships and confirmatory trials. Outcome measures include symptoms, lung function, reduction in concomitant medication, exacerbations, quality of life and measures of inflammation. Interpretation of results need to include the clinical relevance of any changes as well as statistical significance. Special consideration needs to be given to the evaluation of drugs for acute severe asthma, asthma in children and older people, co-morbidity such as rhinitis, and inhaler devices. As with all drugs introduced into practice, careful attention needs to be paid to both short- and long-term safety. (C) 2004 Elsevier Ltd. All rights reserved. [less ▲]

Detailed reference viewed: 45 (4 ULg)
Full Text
Peer Reviewed
See detailHealth-related quality of life in total hip and total knee arthroplasty - A qualitative and systematic review of the literature
Ethgen, Olivier ULg; Bruyère, Olivier ULg; Richy, Florent et al

in Journal of Bone & Joint Surgery. American Volume (2004), 86(5), 963-974

BACKGROUND: Total hip and total knee arthroplasties are well accepted as reliable and suitable surgical procedures to return patients to function. Health-related quality-of-life instruments have been used ... [more ▼]

BACKGROUND: Total hip and total knee arthroplasties are well accepted as reliable and suitable surgical procedures to return patients to function. Health-related quality-of-life instruments have been used to document outcomes in order to optimize the allocation of resources. The objective of this study was to review the literature regarding the outcomes of total hip and knee arthroplasties as evaluated by health-related quality-of-life instruments. METHODS: The Medline and EMBASE medical literature databases were searched, from January 1980 to June 2003, to identify relevant studies. Studies were eligible for review if they met the following criteria: (1). the language was English or French, (2). at least one well-validated and self-reported health-related quality of life instrument was used, and (3). a prospective cohort study design was used. RESULTS: Of the seventy-four studies selected for the review, thirty-two investigated both total hip and total knee arthroplasties, twenty-six focused on total hip arthroplasty, and sixteen focused on total knee arthroplasty exclusively. The most common diagnosis was osteoarthritis. The duration of follow-up ranged from seven days to seven years, with the majority of studies describing results at six to twelve months. The Short Form-36 and the Western Ontario and McMaster University Osteoarthritis Index, the most frequently used instruments, were employed in forty and twenty-eight studies, respectively. Seventeen studies used a utility index. Overall, total hip and total knee arthroplasties were found to be quite effective in terms of improvement in health-related quality-of-life dimensions, with the occasional exception of the social dimension. Age was not found to be an obstacle to effective surgery, and men seemed to benefit more from the intervention than did women. When improvement was found to be modest, the role of comorbidities was highlighted. Total hip arthroplasty appears to return patients to function to a greater extent than do knee procedures, and primary surgery offers greater improvement than does revision. Patients who had poorer preoperative health-related quality of life were more likely to experience greater improvement. CONCLUSIONS: Health-related quality-of-life data are valuable, can provide relevant health-status information to health professionals, and should be used as a rationale for the implementation of the most adequate standard of care. Additional knowledge and scientific dissemination of surgery outcomes should help to ensure better management of patients undergoing total hip or total knee arthroplasty and to optimize the use of these procedures. [less ▲]

Detailed reference viewed: 93 (10 ULg)
Full Text
Peer Reviewed
See detailRisk assessment tools for osteoporosis: scope and limits
Richy, Florent; Gourlay, M.; Ross, P. et al

in Osteoporosis International (2004, May), 15(Suppl.1), 11

Detailed reference viewed: 16 (1 ULg)
Full Text
Peer Reviewed
See detailEvaluation of prevalence of osteoporosis and osteopenia in men presenting at multiple risk detection campaign
Hanssens, L. C.; De Ceulaer, F.; Tancredi, Annalisa ULg et al

in Osteoporosis International (2004, May), 15(Suppl.1), 54

Detailed reference viewed: 32 (4 ULg)
Full Text
Peer Reviewed
See detailEvaluation of the osteoporosis self-assessment tool (OST) as a screening test for osteoporosis and osteopenia in men
DeCeulaer, F.; Hanssens, L.; Tancredi, Annalisa ULg et al

in Osteoporosis International (2004, May), 15(Suppl.1), 54

Detailed reference viewed: 23 (3 ULg)
Full Text
Peer Reviewed
See detailBMD in men: which normative data?
Richy, Florent; Gourlay, M.; Ethgen, Olivier ULg et al

in Osteoporosis International (2004, May), 15(Suppl.1), 54

Detailed reference viewed: 9 (0 ULg)
Full Text
Peer Reviewed
See detailSuccessful prediction of biomarker response to oral monthly ibandronate
Gieschke, R.; Reginster, Jean-Yves ULg

in Osteoporosis International (2004, May), 15(Suppl.1), 97

Detailed reference viewed: 11 (1 ULg)
Full Text
Peer Reviewed
See detailOral monthly ibandronate is well tolerated and efficacious in postmenopausal women: results from the monthly oral pilot study (MOPS)
Reginster, Jean-Yves ULg; Dumont, E.; Wiese, C. et al

in Osteoporosis International (2004, May), 15(Suppl.1), 105-106

Detailed reference viewed: 9 (0 ULg)
Full Text
Peer Reviewed
See detailStrontium ranelate reduces the risk of vertebral and non-vertebral fractures in Caucasian women with postmenopausal osteoporosis
Adami, Silvio; Meunier, Pierre J; Devogelaer, Jean-Pierre et al

in Osteoporosis International (2004, May), 15(Suppl.1), 93-94

Detailed reference viewed: 10 (3 ULg)
Full Text
Peer Reviewed
See detailDo patients with osteoporotic hip fracture recover their initial health-related quality of life?
Ethgen, Olivier ULg; Tancredi, Annalisa ULg; Jacques, Jessica ULg et al

in Osteoporosis International (2004, May), 15(Suppl.1), 50

Detailed reference viewed: 12 (1 ULg)
Full Text
Peer Reviewed
See detailPatients at high risk of hip fracture benefit from treatment with strontium ranelate
Rizzoli, René; Reginster, Jean-Yves ULg; Diaz-Curiel, M. et al

in Osteoporosis International (2004, May), 15(Suppl.1), 18

Detailed reference viewed: 12 (2 ULg)
Full Text
Peer Reviewed
See detailEvaluation of the relationship between IGF-1, IGF-BP3, BMD and age in men presenting at a multiple risk detection campaign
Hanssens, L.; Tancredi, Annalisa ULg; DeCeulaer, F. et al

in Osteoporosis International (2004, May), 15(Suppl.1), 48-49

Detailed reference viewed: 21 (11 ULg)
Full Text
Peer Reviewed
See detailNovel ibandronate regimens in postmenopausal osteoporosis: design of the dosing intravenous administration (DIVA) study
Sambrook, P.; Reginster, Jean-Yves ULg; Recker, R. R. et al

in Osteoporosis International (2004, May), 15(Suppl.1), 118

Detailed reference viewed: 13 (0 ULg)
Full Text
Peer Reviewed
See detailRecommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis
Abadie, Eric ULg; Ethgen, Dominique ULg; Avouac, Bernard ULg et al

in Osteoarthritis and Cartilage (2004), 12(4), 263-268

Background: Recent innovations in the pharmaceutical drug discovery environment have generated new chemical entities with the potential to become disease modifying drugs for osteoarthritis (DMOAD's ... [more ▼]

Background: Recent innovations in the pharmaceutical drug discovery environment have generated new chemical entities with the potential to become disease modifying drugs for osteoarthritis (DMOAD's). Regulatory agencies acknowledge that such compounds may be granted a DMOAD indication, providing they demonstrate that they can slow down disease progression; progression would be calibrated by a surrogate for structural change, by measuring joint space narrowing (JSN) on plain X-rays with the caveat that this delayed JSN translate into a clinical benefit for the patient. Recently, new technology has been developed to detect a structural change of the OA joint earlier than conventional X-rays. Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working party to assess whether these new technologies may be used as surrogates to plain x-rays for assessment of DMOADs. Methods: GREES includes academic scientists, members of regulatory authorities and representatives from the pharmaceutical industry. After an extensive search of the international literature, from 1980 to 2002, two experts meetings were organized to prepare a resource document for regulatory authorities. This document includes recommendations for a possible update of guidelines for the registration of new chemical entities in osteoarthritis. Results: Magnetic resonance imaging (MRI) is now used to measure parameters of cartilage morphology and integrity in OA patients. While some data are encouraging, correlation between short-term changes in cartilage structure observed with MRI and long-term radiographic or clinical changes are needed. Hence, the GREES suggests that MRI maybe used as an outcome in phase II studies, but that further data is needed before accepting MRI as a primary end-point in phase III clinical trials. Biochemical markers of bone and cartilage remodelling are being tested to predict OA and measure disease progression. Recently published data are promising but validation as surrogate end-points for OA disease progression requires additional study. The GREES suggests that biochemical markers remain limited to 'proof of concept' studies or as secondary end-points in phase II and III clinical trials. However, the GREES emphasizes the importance of acquiring additional information on biochemical markers in order to help better understand the mode of action of drugs to be used in OA. Regulatory agencies consider that evidence of improvement in clinical outcomes is critical for approval of DMOAD. Time to total joint replacement surgery is probably the most relevant clinical end-point for the evaluation of efficacy of a DMOAD. However, at this time, time to surgery can not be used in clinical trials because of bias by non disease-related factors like patient willingness for surgery or economic factors. At this stage, it appears that DMOAD should demonstrate a significant difference compared to placebo. Benefit should be measured by 3 co-primary end-points: JSN, pain and function. Secondary end-points should include the percentage of patients who are 'responder' (or 'failure'). The definition of a 'failure' patient would be someone with progression of JSN>0.5 mm over a period of 2-3 years or who has a significant worsening in pain and/or function, based on validated cut-off values. The definition of the clinically relevant cut-off points for pain and function must be based on data evaluating the natural history of the disease (epidemiological cohorts or placebo groups from long-term studies). These cut-offs points should reflect a high propensity, for an individual patient, to later require joint replacement. Conclusion: GREES has outlined a set of guidelines for the development of a DMOAD for OA. Although these guidelines are subject to change as new information becomes available, the information above is based on the present knowledge in the field with the addition of expert opinion. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved. [less ▲]

Detailed reference viewed: 120 (13 ULg)
Full Text
Peer Reviewed
See detailEfficacy of alphacalcidol and calcitriol in primary and corticosteroid-induced osteoporosis: a meta-analysis of their effects on bone mineral density and fracture rate
Richy, F.; Ethgen, Olivier ULg; Bruyère, Olivier ULg et al

in Osteoporosis International (2004), 15(4), 301-310

Vitamin D metabolites alphacalcidol and calcitriol (D-hormones) have been investigated for two decades, but few and conflicting results are available from high-quality randomized controlled trials. Our ... [more ▼]

Vitamin D metabolites alphacalcidol and calcitriol (D-hormones) have been investigated for two decades, but few and conflicting results are available from high-quality randomized controlled trials. Our objectives were to provide an evidence-based update quantitatively summarizing their efficacy on bone mineral density (BMD) and fracture rate. We performed a systematic research of any randomized controlled trial containing relevant data, peer review, data extraction and quality scoring blinded for authors and data sources, and comprehensive meta-analyses of the relevant data. Inclusion criteria were: randomized controlled study, calcitriol or alphacalcidol, BMD or fractures in healthy/osteopenic/osteoporotic patients exposed or not to corticosteroids (CS). Analyses were performed in a conservative fashion using professional dedicated softwares and stratified by outcome, target patients, study quality, and control-group type. Results were expressed as effect size (ES) for bone loss or relative risk (RR) for fracture while allocated to D-hormones vs control. Publication bias and robustness were investigated. Of the trials that were retrieved and subsequently reviewed, 17 papers fitted the inclusion criteria and were assessed. Quality scores ranged from 20 to 100%, the mean (standard deviation) being 72 (22)%. Calcitriol and alphacalcidol were found to have the same efficacy on all outcomes at p>0.13. We globally assessed D-hormones effects in preventing bone loss in patients not exposed to CS, and found positive effect: ES=0.39 (p<0.001). For lumbar spine, this particular effect was 0.43 (p<0.001). D-hormones significantly reduced the overall fracture rates: RR=0.52 (0.46; 0.59) and both vertebral and non-vertebral fractures: RR=0.53 (0.47; 0.60) and RR=0.34 (0.16; 0.71), respectively. No statistical difference in response was observed between results from studies on healthy and osteoporotic patients or depending on the fact that controls were allowed to calcium supplementation. Treatment with D-hormones was evaluated for maintaining spinal bone mass in five trials of patients with CS-induced osteoporosis, and provided ES=0.43 at p<0.001. Only two studies specifically addressed the effects of calcitriol on spinal fracture rate. None of them provided significant results, and the global RR did not reach the significance level as well: RR=0.33 (0.07; 1.51). Our data demonstrated efficacy for DH on bone loss and fracture prevention in patients not exposed to CS and on bone loss in patients exposed to CS, in the light of the most reliable scientific evidence. Their efficacy in reducing the number of fractures in patients exposed to CS remains to be determined. [less ▲]

Detailed reference viewed: 40 (7 ULg)
Full Text
Peer Reviewed
See detailRelationship between changes in biochemical markers of bone turnover and BMD to predict vertebral fracture risk
Sarkar, S.; Reginster, Jean-Yves ULg; Crans, G. G. et al

in Journal of Bone and Mineral Research (2004), 19(3), 394-401

The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent ... [more ▼]

The change in BMD is a poor predictor of vertebral fracture risk after raloxifene treatment. One-year percent change in bone turnover and BMD was used to predict vertebral fracture risk. The percent change in osteocalcin was determined to be a better predictor of vertebral fracture risk than BMD. Introduction: The association between baseline BMD and fracture risk is well understood. However, the relationship between changes in BMD and fracture risk is not well defined. It has previously been demonstrated that BMD change was a poor predictor of vertebral fracture risk in raloxifene-treated women, whereas bone turnover markers were significantly associated with fracture risk. In the current analysis, we explore the prediction of vertebral fracture risk using changes in both BMD and bone turnover. Materials and Methods: The Multiple Outcomes of Raloxifene Evaluation (MORE) trial was a randomized, placebo-controlled trial of 7705 women with osteoporosis treated with raloxifene 60 or 120 mg/day for 3 years. Markers of bone turnover were measured in one-third of the study population (n = 2503), and the present analyses include these women. Logistic regression models were constructed using one-year percent changes in BMD and bone turnover and relevant baseline demographics to predict the risk of vertebral fracture with pooled raloxifene therapy at 3 years. All covariates were standardized before modeling to facilitate direct comparisons between changes in BMD and bone turnover. Results and Conclusion: Prevalent vertebral fracture status (p < 0.0001), baseline lumbar spine BMD (p < 0.0001), and number of years postmenopausal (p = 0.0005) were independent predictors of fracture risk in raloxifene-treated patients. Therapy-by-change in femoral neck BMD (p = 0.02) and therapy-by-change in osteocalcin (OC; p = 0.01) were also significant for all treatment groups, indicating that changes in BMD and OC have different effects on fracture risk for the placebo and pooled raloxifene groups. The final model included significant baseline variables and change in OC (p = 0.01), whereas change in femoral neck BMD was not significant. After adjustment of each significant baseline variable, the percent change in OC was better able to predict the reduction in vertebral fracture risk than the percent change in femoral neck BMD in patients treated with raloxifene. [less ▲]

Detailed reference viewed: 24 (0 ULg)