References of "REGINSTER, Jean-Yves"
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See detailLumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib
Tannenbaum, H.; Berenbaum, F.; Reginster, Jean-Yves ULg et al

in Annals of the Rheumatic Diseases (2004), 63(11), 1419-1426

Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis (OA) in a 13 week, multicentre, randomised, double blind study. Methods: After a 327 day washout ... [more ▼]

Objectives: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis (OA) in a 13 week, multicentre, randomised, double blind study. Methods: After a 327 day washout period for non-steroidal anti-inflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400 mg once daily (od), celecoxib 200 mg od, or placebo (2:2:2:1). A visual analogue scale (VAS) pain intensity greater than or equal to40 mm was required. Primary efficacy variables were OA pain intensity (VAS mm) in the target knee, patient's global assessment of disease activity (VAS mm), and WOMAC pain subscale and total scores at 13 weeks. OA pain intensity, patient's and physician's global assessment of disease activity, and WOMAC (total and all subscale scores) were analysed by visit as secondary variables. Results: Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200 mg od and celecoxib 200 mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400 mg od demonstrated better efficacy for OA pain intensity and patient's global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200 mg od. The incidence of adverse events (AEs), serious AEs, and discontinuations due to AEs was similar in each group. Conclusion: Lumiracoxib demonstrated significant improvement in OA pain intensity, patient's global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib. [less ▲]

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See detailDevelopment and validation of the ORACLE score to predict risk of osteoporosis
Richy, F.; Deceulaer, F.; Ethgen, Olivier ULg et al

in Mayo Clinic Proceedings (2004), 79(11), 1402-1408

OBJECTIVE: To develop and validate a composite index, the Osteoporosis Risk Assessment by Composite Linear Estimate (ORACLE), that includes risk factors and ultrasonometric outcomes to screen for ... [more ▼]

OBJECTIVE: To develop and validate a composite index, the Osteoporosis Risk Assessment by Composite Linear Estimate (ORACLE), that includes risk factors and ultrasonometric outcomes to screen for osteoporosis. SUBJECTS AND METHODS: Two cohorts of postmenopausal women aged 45 years and older, participated in the development (n = 407) and the validation (n = 202) of ORACLE. Their bone mineral density was determined by dual energy x-ray absorptiometry and quantitative ultrasonometry (QUS), and their historical and clinical risk factors were assessed (January to June 2003). Logistic regression analysis was used to select significant predictors of bone mineral density, whereas receiver operating characteristic (ROC) analysis was used to assess the discriminatory performance of ORACLE. RESULTS: The final logistic regression model retained 4 biometric or historical variables and 1 ultrasonometric outcome. The ROC areas under the curves (AUCs) for ORACLE were 84% for the prediction of osteoporosis and 78% for low bone mass. A sensitivity of 90% corresponded to a specificity of 50% for identification of women at risk of developing osteoporosis. The corresponding positive and negative predictive values were 86% and 54%, respectively, in the development cohort. In the validation cohort, the AUCs for identification of osteoporosis and low bone mass were 81% and 76% for ORACLE, 69% and 64% for QUS T score, 71% and 68% for QUS ultrasonometric bone profile index, and 76% and 75% for Osteoporosis Self-assessment Tool, respectively. ORACLE had the best discriminatory performance in identifying osteoporosis compared with the other approaches (P < .05). CONCLUSION: ORACLE exhibited the highest discriminatory properties compared with ultrasonography alone or other previously validated risk indices. It may be helpful to enhance the predictive value of QUS. [less ▲]

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See detailTraitement de l'osteoporose postmenopausique en 2004
Reginster, Jean-Yves ULg; Devogelaer, Jean-Pierre

in Revue Médicale de Liège (2004), 59(11), 633-47

Major improvements have been observed, during the last ten years, in the management of postmenopausal osteoporosis. The most significant benefits have been obtained through the availability of new ... [more ▼]

Major improvements have been observed, during the last ten years, in the management of postmenopausal osteoporosis. The most significant benefits have been obtained through the availability of new medications which have demonstrated their anti-fracture efficacy in the course of well conducted, scientifically sound studies. Due to the pharmacological properties of these new medications, treatment of osteoporosis can now be tailored to the needs of each and every single postmenopausal woman. Calcium supplementation (500 mg/day) should be offered to all post menopausal women unless dietary records show a sufficient intake. On the grounds of the high prevalence of low serum vitamin D levels in the ederly Belgian population, the systematic use of a calcium-vitamin D combination, after the age of 65 years, appears to be justified. Raloxifene is an interesting option for women with low mineral density or prevalent vertebral fractures. This molecule has demonstrated unequivocal anti-fracture efficacy at the level of the spine and is also caracterized by a beneficial effect on non-spinal fractures, in high risk women. Bisphosphonates (alendronate and risedronate) have shown the anti-fracture efficacy at the level of the axial and appendicular skeleton. The availability of a weekly formulation improves their compliance, notwithstanding the constrains related to the potential upper gastro-intestinal toxicity of these compounds. Bisphosphonates appear to be the first-line choice for patients with more severe osteoporosis and high risk to develop hip fractures. Teriparatide (1-34 Fragment of parathyroid hormone) is a new pharmacological option, oriented, mainly if not exclusively because of its parenteral administration and high cost, to patients with severe osteoporosis (low bone density and prevalent vertebral fracture(s). Strontium ranelate offers an anti-fracture efficacy at all skeleton sites and an oustanding overall tolerance and may play a main role in the future management of osteoporosis. [less ▲]

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See detailDifferential Regulation of Chondrocyte Metabolism by Oncostatin M and Interleukin-6
Sanchez, Christelle ULg; Deberg, Michelle ULg; Devel, Philippe et al

in Osteoarthritis and Cartilage (2004), 12(10), 801-10

OBJECTIVE: To determine the effects of interleukin (IL)-6 and oncostatin M (OSM) added separately or in combination with IL-1beta on human osteoarthritic (OA) chondrocytes in alginate beads. DESIGN: Human ... [more ▼]

OBJECTIVE: To determine the effects of interleukin (IL)-6 and oncostatin M (OSM) added separately or in combination with IL-1beta on human osteoarthritic (OA) chondrocytes in alginate beads. DESIGN: Human chondrocytes were isolated from OA cartilage and cultured in alginate beads for 12 days, in the absence or in the presence of increasing amounts of IL-6 (20-500ng/ml) with its soluble receptor or OSM (0.1-10ng/ml) and with or without IL-1beta (1.7ng/ml). Aggrecan (AGG), transforming growth factor-beta1 (TGF-beta1), stromelysin-1 [matrix metalloprotease (MMP)-3], tissue inhibitor of metalloproteinases-1 (TIMP-1), macrophage inflammatory protein-1 beta (MIP-1beta), IL-6 and IL-8 productions were assayed by specific enzyme amplified sensitivity immunoassays. Prostaglandin (PG)E(2) was measured by a specific radioimmunoassay and nitrite (NO(2)(-)) by a spectrophotometric method based upon the Griess reaction. RESULTS: OSM, but not IL-6, decreased basal AGG and TGF-beta1 synthesis. Although IL-6 stimulated basal TIMP-1 production, it did not significantly modify MMP-3/TIMP-1 ratio. In contrast, 10ng/ml OSM highly increased TIMP-1 production, and decreased by half the ratio MMP-3/TIMP-1. IL-1beta highly stimulated *NO, IL-8, IL-6, MIP-1beta and PGE(2) synthesis but decreased AGG and TGF-beta1 production. Neither IL-6 nor OSM modulated IL-1beta-inhibitory effect on AGG production. IL-6, but not OSM, reversed IL-1beta-induced TGF-beta1 inhibition. At 1-10ng/ml, OSM significantly decreased IL-1beta-stimulated IL-8, MIP-1beta, PGE(2) and *NO production but amplified IL-1beta stimulating effect on IL-6 production. IL-6 had no effect on these parameters. CONCLUSIONS: OSM and IL-6, two glycoprotein 130 binding cytokines, show different activity profiles on OA chondrocytes, indicating that these cytokines could play different roles in the OA disease process. [less ▲]

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See detailInterest of the androgen deficiency in aging males (ADAM) questionnaire for the identification of hypogonadism in elderly community-dwelling male volunteers
Tancredi, Annalisa ULg; Reginster, Jean-Yves ULg; Schleich, FLorence ULg et al

in European Journal of Endocrinology (2004), 151(3), 355-360

Objective: To date, serum free testosterone measurement is considered to be the gold standard for the diagnosis of hypogonadism in elderly males but it is not available to all subjects suspected of a ... [more ▼]

Objective: To date, serum free testosterone measurement is considered to be the gold standard for the diagnosis of hypogonadism in elderly males but it is not available to all subjects suspected of a decrease in testicular function. Therefore, we evaluated whether the Androgen Deficiency in Aging Males (ADAM) questionnaire, in its original or in a modified 'quantitative' version (qADAM), could be used as a surrogate to biochemical determinations for the identification of hypogonadism in elderly males. Methods: 5028 men, aged 50-70 years, spontaneously consulting for the assessment of their gonadal function were studied. ADAM and qADAM, allocating a value of 1 point for any positive answer to each of the 10 questions of the ADAM test, were assessed for their ability to discriminate between males with free testosterone levels below or above 70 ng/l. Results: The sensitivity and specificity of the ADAM score were 81% and 21.6% respectively. The use of ADAM resulted in an appropriate classification of our population in normal or hypogonadal subjects in 44.5% of the cases. The area under the receiver operating characteristics (ROC) curve for the qADAM (0.529) revealed a highly marginal interest of this quantitative approach compared with the original scoring system. Conclusions: The ADAM test has a high sensitivity to identify aging males with low free testosterone levels. However, due to its lack of specificity, this test cannot be used as a surrogate to serum free testosterone testing for the identification of androgen deficiency in elderly, community-dwelling males. [less ▲]

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See detailA new treatment for the reduction of vertebral and non-vertebral fractures in post-menopausal women with osteoporosis
Reginster, Jean-Yves ULg; Brixen, Kim; Bianchi, Gerolamo et al

in Arthritis and Rheumatism (2004, September), 50(number 9 (suppl.)), 291

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See detailStrontium treatment has a pronounced Effect on cartilage degradation in postmenopausal women
Alexandersen, Peter; Tanko, Laszlo B; Bagger, Yu Z et al

in Arthritis and Rheumatism (2004, September), 50(number 9 (suppl.)), 346

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See detailTolerability of monthly oral ibandronate in postmenopausal osteoporosis: 1-year results from the MOBILE Study
Recker, Robert R; Silverman, Stuart L; Kendler, David L et al

in Arthritis and Rheumatism (2004, September), 50(number 9 (suppl.)), 293

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See detailSafety and efficacy of a novel salmon calcitonin (sCT) technology-based oral formulation in healthy postmenopausal women: Acute and 3-month effects on biomarkers of bone turnover
Tanko, L. B.; Bagger, Y. Z.; Alexandersen, P. et al

in Journal of Bone and Mineral Research (2004), 19(9), 1531-1538

Oral administration of calcitonin could improve compliance to long-term treatment. Efficacy and safety of a novel oral formulation was assessed on 277 postmenopausal women. The results show (1) effective ... [more ▼]

Oral administration of calcitonin could improve compliance to long-term treatment. Efficacy and safety of a novel oral formulation was assessed on 277 postmenopausal women. The results show (1) effective enteral absorption, (2) marked inhibition of bone resorption with minimal alteration of formation, and (3) reproducibility of responses over 3 months. Introduction: We have recently introduced an Eligen technology-based oral formulation of salmon calcitonin (sCT) that effectively delivers the hormone to the circulation. The efficacy and safety during longer-term administration, however. has not been investigated in the target population. Materials and Methods: This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age. Women received treatment with either daily (0.15, 0.4. 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months. All participants received 1000 mg calcium plus 400 IU vitarnin D daily throughout the study. Efficacy parameters were the acute and/or pre-dose changes in serum and urinary C-terminal telopeptide of type I collagen (CTx), N-mid osteocalcin (OC), bone-specific alkaline phosphatase (BSALP), calcium, and parathyroid hormone (PTH) measured by established immunoassays. Results: After the first dose, sCT evoked dose-dependent decreases in serum CTx (-60.8% to -81.8% from baseline) compared with placebo, reaching nadirs 2-3 h after drug intake, after which, gradual increases were observed. The simultaneous acute changes in OC were statistically nonsignificant. Area under the curve (AUC) of serum CTx responses at months 1 and 3 showed strong correlation with those at baseline (both r = 0.78, p < 0.001). At month 3. the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05). The placebo-corrected change in OC was - 8.6 (p = 0.09), whereas the change in BSALP was -7.3 (p = 0.02). The oral formulation was well tolerated, with mild to moderate gastrointestinal and skin manifestations apparent mainly in the high-dose groups. Conclusion: The results of this 3-month trial show that the novel Eligen technology-based oral formulation of sCT has potential to become a safe and effective treatment for postmenopausal bone loss. Future trials are needed to assess the impact of long-term administration on changes in BMD and fracture risk. [less ▲]

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See detailTime dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach
Richy, F.; Bruyère, Olivier ULg; Ethgen, Olivier ULg et al

in Annals of the Rheumatic Diseases (2004), 63(7), 759-766

OBJECTIVES: To provide an updated document assessing the global, NSAID-specific, and time dependent risk of gastrointestinal (GI) complications through meta-analyses of high quality studies. METHODS: An ... [more ▼]

OBJECTIVES: To provide an updated document assessing the global, NSAID-specific, and time dependent risk of gastrointestinal (GI) complications through meta-analyses of high quality studies. METHODS: An exhaustive systematic search was performed. Inclusion criteria were: RCT or controlled study, duration of 5 days at least, inactive control, assessment of minor or major NSAID adverse effects, publication range January 1985 to January 2003. The publications retrieved were assessed during a specifically dedicated WHO meeting including leading experts in all related fields. Statistics were performed conservatively. Meta-regression was performed by regressing NSAID adjusted estimates against study duration categories. RESULTS: Among RCT data, indolic derivates provided a significantly higher risk of GI complications related to NSAID use than for non-users: RR = 2.25 (1.00; 5.08) than did other compounds: naproxen: RR = 1.83 (1.25; 2.68); diclofenac: RR = 1.73 (1.21; 2.46); piroxicam: RR = 1.66 (1.14; 2.44); tenoxicam: RR = 1.43 (0.40; 5.14); meloxicam: RR = 1.24 (0.98; 1.56), and ibuprofen: RR = 1.19 (0.93; 1.54). Indometacin users had a maximum relative risk for complication at 14 days. The other compounds presented a better profile, with a maximum risk at 50 days. Significant additional risk factors included age, dose, and underlying disease. The controlled cohort studies provided higher estimates: RR = 2.22 (1.7; 2.9). Publication bias testing was significant, towards a selective publication of deleterious effects of NSAIDs from small sized studies. CONCLUSION: This meta-analysis characterised the "compound" and "time" aspects of the GI toxicity of non-selective NSAIDs. The risk/benefit ratio of such compounds should thus be carefully and individually evaluated at the start of long term treatment. [less ▲]

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See detailThe need for clinical guidance in the use of calcium and vitamin D in the management of osteoporosis: a consensus report
Boonen, S.; Rizzoli, R.; Meunier, P. J. et al

in Osteoporosis International (2004), 15(7), 511-519

A European Union (EU) directive on vitamins and minerals used as ingredients of food supplements with a nutritional or physiological effect (2002/46/EC) was introduced in 2003. Its implications for the ... [more ▼]

A European Union (EU) directive on vitamins and minerals used as ingredients of food supplements with a nutritional or physiological effect (2002/46/EC) was introduced in 2003. Its implications for the use of oral supplements of calcium and vitamin D in the prevention and treatment of osteoporosis were discussed at a meeting organized with the help of the World Health Organization ( WHO) Collaborating Center for Public Health Aspects of Rheumatic Diseases (Liege, Belgium) and the support of the WHO Collaborating Center for Osteoporosis Prevention (Geneva, Switzerland). The following issues were addressed: Is osteoporosis a physiological or a medical condition? What is the evidence for the efficacy of calcium and vitamin D in the management of postmenopausal osteoporosis? What are the risks of self-management by patients in osteoporosis? From their discussions, the panel concluded that: (1) osteoporosis is a disease that requires continuing medical attention to ensure optimal therapeutic benefits; (2) when given in appropriate doses, calcium and vitamin D have been shown to be pharmacologically active (particularly in patients with dietary deficiencies), safe, and effective for the prevention and treatment of osteoporotic fractures; (3) calcium and vitamin D are an essential, but not sufficient, component of an integrated management strategy for the prevention and treatment of osteoporosis in patients with dietary insufficiencies, although maximal benefit in terms of fracture prevention requires the addition of antiresorptive therapy; (4) calcium and vitamin D are a cost-effective medication in the prevention and treatment of osteoporosis; (5) it is apparent that awareness of the efficacy of calcium and vitamin D in osteoporosis is still low and further work needs to be done to increase awareness among physicians, patients, and women at risk; and (6) in order that calcium and vitamin D continues to be manufactured to Good Manufacturing Practice standards and physicians and other health care professionals continue to provide guidance for the optimal use of these agents, they should continue to be classified as medicinal products. [less ▲]

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See detailThe OST risk tool performs consistently for identifying women at risk of osteoporosis across populations
Reginster, Jean-Yves ULg; Richy, Florent

in Annals of the Rheumatic Diseases (2004, June)

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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)

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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)

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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)

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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 ▲]

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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 ▲]

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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 ▲]

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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

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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

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