References of "REGINSTER, Jean-Yves"
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See detailSubchondral tibial bone mineral density predicts future joint space narrowing at the medial femoro-tibial compartment in patients with knee osteoarthritis
Bruyère, Olivier ULg; Dardenne, Charles-Bernard ULg; Lejeune, Eric ULg et al

in BONE (2003), 32(5), 541-545

Preliminary studies have shown that dual-energy X-ray absorptiometry (DXA) produces images of sufficient quality for a precise and accurate measurement at density of the subchondral bone. The objective of ... [more ▼]

Preliminary studies have shown that dual-energy X-ray absorptiometry (DXA) produces images of sufficient quality for a precise and accurate measurement at density of the subchondral bone. The objective of this study was to investigate the relationship between baseline subchondral tibial bone mineral density (BMD) and joint space narrowing observed after 1 year at the medial femoro-tibial compartment of the knee joint. Fifty-six consecutive patients, from both genders, with knee osteoarthritis diagnosed according to the American College of Rheumatology criteria, were included in the study. Radiographic posteroanterior views were taken, at baseline and after 1 year of follow-up. Minimum joint space width (JSW) measurement, at the medial femoro-tibial joint, was performed with a 0.1-mm graduated magnifying lens. Baseline BMD of the subchondral tibial bone was assessed by DXA. The mean +/- SD age of the patients was 65.3 +/- 8.7 years, with a body mass index of 28.0 +/- 4.9 kg/m(2). The minimum JSW was 3.5 +/- 1.5 mm and the mean BMD of the subchondral bone was 0.848 +/- 0.173 g/cm(2). There was a significant negative correlation between subchondral BMD and 1-year changes in minimum JSW (r = -0.43, p = 0.02). When performing a multiple regression analysis with age, sex, body mass index, and minimum JSW at baseline as concomitant variables, BMD of the subchondral bone as well as JSW at baseline were independent predictors of 1-year changes in JSW (p = 0.02 and p = 0.005, respectively). Patients in the lowest quartile of baseline BMD (<0.73 g/cm(2)) experienced less joint space narrowing than those in the highest BMD quartile (>0.96 g/cm(2)) (+0.61 +/- 0.69 turn versus -0.13 +/- 0.27 mm; p = 0.03). Assessment of BMD of the subchondral tibial bone is significantly correlated with future joint space narrowing and could be used as a predictor of knee osteoarthritis progression. (C) 2003 Elsevier Science (USA). All rights reserved. [less ▲]

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See detailInterest of biochemical markers of bone turnover for long-term prediction of new vertebral fracture in postmenopausal osteoporotic women
Bruyère, Olivier ULg; Collette, Julien ULg; Delmas, Pierre et al

in Maturitas (2003), 44(4), 259-265

Objective: To analyse the interest of baseline levels and short-term (3-months) changes in serum osteocalcin (BGP), serum bone-specific alkaline phosphatase (BALP) and urinary C-telopeptide of type I ... [more ▼]

Objective: To analyse the interest of baseline levels and short-term (3-months) changes in serum osteocalcin (BGP), serum bone-specific alkaline phosphatase (BALP) and urinary C-telopeptide of type I collagen/creatinine ratio (U-TX) to predict 3-years changes in bone mineral density (BMD) and spinal deformity index (SDI) in postmenopausal osteoporotic women. Methods: Data were derived from a cohort of 603 osteoporotic women corresponding to the placebo arm of a 3-years prospective, double-blind study. Results: Baseline values of BALP, BGP and U-CTX were negatively and significantly correlated with baseline spinal BMD. Significant correlations were also observed between the changes in BMD observed after 36 months at the spine and baseline BALP (r = 0.20, P = 0.0001), BGP (r = 0.09, P = 0.05) and U-CTX (r = -0.11, P = 0.02). At 3 years, 71 women (15.9%) showed an increase in their SDI, corresponding to the occurrence of at least one new vertebral deformity. Baseline values of the four bone turnover markers (BTM) were not significantly related to the occurrence of new vertebral deformities. However, when considering the changes in the BTM observed after 3-months of follow-up, BGP (P = 0.003) and U-CTX (P = 0.047) were identified as significant predictors of an increase of SDI. The associated odds ratios (95% confidence interval (CI)) were 10.922 (2.218-53.78) for unit changes of log BGP and 1.369 (1.003-1.867) for unit changes of log U-CTX. The relative risk (RR) (IC 95%) of having a new vertebral fracture over 36 months was 0.31 (0.15-0.65) when being in the lowest quartile of 3-months changes in BGP as compared with the highest. Conclusion: We conclude that two sequential measurements of BGP and U-CTX performed at 3-months intervals could be of interest to identify postmenopausal osteoporotic women with the highest risk to present new vertebral deformities. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved. [less ▲]

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See detailImpact of the joint space width measurement method on the design of knee osteoarthritis studies.
Bruyère, Olivier ULg; Henrotin, Yves ULg; Honore, Aline et al

in Aging Clinical & Experimental Research (2003), 15(2), 136-41

BACKGROUND AND AIMS: Recent guidelines recommend measurement of articular loss over several years, determined by conventional X-rays, as the principal outcome measure in clinical trials of potential ... [more ▼]

BACKGROUND AND AIMS: Recent guidelines recommend measurement of articular loss over several years, determined by conventional X-rays, as the principal outcome measure in clinical trials of potential structure-modifying drugs in osteoarthritis (OA). The aim of this study was to assess the impact of the joint space width measurement method on sample size calculation in knee OA studies. METHODS: Standard knee X-rays were taken in 212 patients with knee OA at baseline and after 3 years of follow-up. Mean joint space width (JSW) was measured with an in-house computer-assisted method. Minimum JSW, measured with a graduated magnifying lens, was taken as external standard. After calculation of the intra- and inter-observer reproducibility of the JSW, sensitivity to change was assessed using the standardized response mean (SRM). The number of patients needed to identify a mean significant difference of 0.5 mm in joint space narrowing between the placebo and the treated group, after 3 years of follow-up, was then calculated. RESULTS: JSW measured with the computer-assisted technique showed better intra- and inter-observer reproducibility than when using the magnifying lens. JSW values measured with our computer-assisted method were significantly correlated with JSW values obtained using the magnifying lens (r=0.87, p<0.001). The SRM were 0.44 and 0.40 for the computer-assisted method and magnifying lens, respectively. The number of patients needed was 131 per group using the computer-assisted method, and 104 using the magnifying lens. CONCLUSIONS: Our method of measurement of JSW may be of potential use in longitudinal studies evaluating the effect of structure-modifying drugs in OA, due to its high level of precision and efficiency. However, although sensitivity to change is markedly better with the digitized method compared with the graduated magnifying lens, we recommend the measurement of mean and minimum JSW in structure-modifying OA trials. [less ▲]

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See detailA risk assessment tool (osterorisk) for identifying latin american women with osteoporosis
Sen, SS; Geling, O; Messina, OD et al

in Revista Metabolismo Oseo y Mineral (2003, March), 1(1), 39-40

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See detailInhaled corticosteroids effects on bone in asthmatic and COPD patients: a quantitative systematic review
Richy, Florent; Bousquet, Jean; Ehrlich, George E et al

in Osteoporosis International (2003), 14(3), 179-190

Deleterious effect of oral corticosteroids on bone has been well documented, whereas this remains debated for inhaled ones (ICS). Our objectives were to analyze the effects of ICS on bone mineral density ... [more ▼]

Deleterious effect of oral corticosteroids on bone has been well documented, whereas this remains debated for inhaled ones (ICS). Our objectives were to analyze the effects of ICS on bone mineral density, fracture risk and bone markers. We performed an exhaustive systematic research of all controlled trials potentially containing pertinent data, peer-reviewed by a dedicated WHO expert group, and comprehensive meta-analyses of the data. Inclusion criteria were ICS, and BMD/markers/fractures in asthma/chronic obstructive pulmonary diseases (COPD) and healthy patients. Analyses were performed in a conservative fashion using professional dedicated softwares and stratified by outcome, study design and ICS type. Results were expressed as standardized mean difference/effect size (ES), relative risk (RR) or odds ratio (OR), depending on study design and outcome units. Publication bias was investigated. Twenty-three trials were reviewed; 11 papers fit the inclusion criteria and were assessed for the main analysis. Quality scores for the randomized controlled trials (RCTs) were 80%, 71% for the prospective cohort studies, and 78% for the retrospective cohort and cross-sectional studies. We globally assessed ICS effects on BMD and found deleterious effects: ES=0.61 (p=0.001) for healthy subjects, and ES=0.27 (p<0.001) for asthma/COPD patients. For these patients, this effect was 0.21 (p<0.01) at the lumbar spine, and 0.26 (p<0.001) at the hip or femoral neck. A single study evaluated the impact of ICS on hip fracture and reported an increased OR of 1.6 (1.24; 2.03). Lumbar fracture rate differences did not reach the level of statistical significance: 1.87 (0.5; 6.94). Osteocalcin and PICP were decreased and ICTP, pyridinoline and deoxypyridinoline levels were not significantly affected. Budesonide (BUD) appeared to be the ICS inducing the less deleterious effects on bone, followed by beclomethasone dipropionate (BDP) and triamcinolone (TRI). Publication bias investigation provided non-significant results. In our meta-analyses, BUD at a mean daily dose (SD) of 686 mug (158 mug), BDP at 703 mug (123 mug) and TRI at 1000 mug (282 mug) were found to affect bone mineral density and markers in patients suffering from the two major respiratory diseases. These findings could have practical implication in the long-term management of asthmatic and COPD patients. [less ▲]

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See detailEffects of rhein on human articular chondrocytes in alginate beads
Sanchez, Christelle ULg; Mathy-Hartert, Marianne; Deberg, Michelle ULg et al

in Biochemical Pharmacology (2003), 65(3), 377-388

This study was designed to investigate the effects of them, the active metabolite of diacerhein, on the metabolic functions of human chondrocytes cultured in alginate beads. Enzymatically isolated ... [more ▼]

This study was designed to investigate the effects of them, the active metabolite of diacerhein, on the metabolic functions of human chondrocytes cultured in alginate beads. Enzymatically isolated ostcoarthritic (OA) chondrocytes were cultured in alginate beads in a well-defined culture medium for 12 days. Rhein was tested in a range of concentrations comprised between 10(-7) and 4 x 10(-5) M, in the presence or absence of 10(-10) M IL-1beta. Interleukin (IL)-6 and -8, macrophage inflammatory protein (MIP-1beta), stromelysin-1 (MMP-3), aggrecan (AGG), tissue inhibitor of metalloproteinases-1 (TIMP-1), prostaglandin E-2 (PGE(2)) and nitric oxide (NO) productions were assayed. Cyclooxygenase-2 (COX-2) and inducible NO synthase (iNOS) mRNA steady-state levels were also quantified. In the basal condition, 10(-5) M them increased by 46.5% the production of AGG, decreased by 17-30% the production of IL-6, MMP-3, NO and MIP-1beta but enhanced by 50% the production of PGE2(.) IL-1beta increased IL-6, IL-8, MIP-1beta, NO, PGE(2) and MMP-3 productions, but inhibited AGG and TIMP-1 synthesis. Rhein partially reversed the effect of IL-1beta on TIMP-1 and NO production, had no effect on AGG, IL-6 and MIP-1P production, but upregulated the IL-1beta stimulated PGE(2) production. The COX-2 and iNOS mRNA levels and IL-8 production were not modified by rhein. Overall, these results contribute to explain the clinical efficiency of rhein and give new information on its mechanisms of action. (C) 2002 Elsevier Science Inc. All rights reserved. [less ▲]

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See detailStrontium ranelate: A new paradigm in the treatment of osteoporosis
Reginster, Jean-Yves ULg; Deroisy, Rita ULg; Jupsin, Isabelle ULg

in Drugs of Today (2003), 39(2), 89-101

Not one of the currently available medications has, so far, unequivocally demonstrated its ability to fully prevent the occurrence of new vertebral or peripheral osteoporotic fractures once osteoporosis ... [more ▼]

Not one of the currently available medications has, so far, unequivocally demonstrated its ability to fully prevent the occurrence of new vertebral or peripheral osteoporotic fractures once osteoporosis is established. Therefore, several new therapies are currently under development to optimize the risk/benefit ratio of osteoporosis treatment. Strontium ranelate is composed of an organic moiety (ranelic acid) and of two atoms of stable nonradioactive strontium. In vitro, strontium ranelate increases Collagen and noncollagenic proteins synthesis by mature osteoblast enriched cells. The effects of strontium ranelate on bone formation were confirmed as strontium ranelate enhanced pre-osteoblastic cell replication. The stimulation by strontium ranelate of the replication of osteoprogenitor cell and collagen, as well as noncollagenic protein synthesis in osteoblasts, provides substantial evidence to categorize strontium ranelate as a bone-forming agent. In the isolated rat osteoclast assay, a pre-incubation of bone slices with strontium ranelate induced a dose-dependent inhibition of the bone resorbing activity of treated rat osteoclast. Strontium ranelate also dose-dependently inhibited, in a chicken bone marrow culture, the expression of both carbonic anhydrase 11 and the (x-subunit of the vitronectin receptor. These effects showing that strontium ranelate significantly affects bone resorption due to a direct and/or matrix-mediated inhibition of osteoclast activity and also inhibits osteoclasts differentiation, are compatible with the profile of an anti-resorptive drug. In normal rats, administration of strontium ranelate induces an improvement in the mechanical properties of the humerus and/or the lumbar vertebra associated with a commensurate increase in bone dimension, shaft and volume. Strontium ranelate was administered in 160 early postmenopausal women, in a 24-month, double-blind, placebo-controlled, prospective randomized study. Daily oral dose of 125 mg, 500 mg and 1 g of strontium ranelate were compared with a placebo. At the conclusion of the study, the percent variation of lumbar-adjusted bone mineral density from baseline was significantly different in the group receiving 1 g/day of strontium ranelate compared with placebo (+1.41% vs. -0.98%, respectively). Increase in total hip and neck bone mineral density averages, respectively, 3.2% and 2.5%. Strontium ranelate does not induce any significant adverse reaction compared with those observed in women receiving a placebo for the same duration. In a phase 11 study, the effect of strontium ranelate in postmenopausal women with vertebral osteoporotic fractures was assessed during a double-blind, placebo-controlled trial. Doses of 500 mg, 1 g and 2 g daily of strontium ranelate or placebo were given to 353 Caucasian women with prevalent osteoporosis. At the conclusion of this 2-year study, the annual increase in lumbar-adjusted bone mineral density of the group receiving 2 g of strontium ranelate was +2.97%. This result was significantly different compared with placebo. A significant increase in bone alkaline phosphatase and, over a 6-month period, a significant decrease in urinary-pyridium crosslinks (NTX) were evidenced. During the second year of treatment, the dose of 2 g was associated with a 44% reduction in the number of patients experiencing a new vertebral deformity. Bone histomorphometry showed no mineralization defects. The same percentage of withdrawals following an adverse effect was observed for patients receiving placebo and for those receiving 2 g of strontium ranelate. The compound was further investigated in a large phase III program that included two extensive trials for the treatment of severe osteoporosis, one assessing the effects of strontium ranelate on the risk of vertebral fractures (SOTI) and one evaluating its effects on peripheral (nonspinal) fractures (TROPOS). The primary analysis of the SOTI study, evaluating the effect of 2 g of strontium ranelate on vertebral fracture rates, revealed a 41% reduction in the relative risk of experiencing a first new vertebral fracture with strontium ranelate, throughout the 3-year study, compared with placebo. The TROPOS study, showed a significant (p = 0.05) reduction in the relative risk of experiencing a first non-vertebral fracture in the group treated with strontium ranelate throughout the 3-year study compared with placebo in the intention-to-treat population. A 41% reduction in the relative risk of experiencing a hip fracture was demonstrated in the per protocol population. All these results imply that strontium ranelate is a new, effective and safe treatment for vertebral and nonvertebral osteoporosis, with a unique mode of action. (C) 2003 Prous Science. All rights reserved. [less ▲]

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See detailPatient assessment using standardized bone mineral density values and a national reference database: implementing uniform thresholds for the reimbursement of osteoporosis treatments in Belgium
Boonen, S.; Kaufman, J. M.; Reginster, Jean-Yves ULg et al

in Osteoporosis International (2003), 14(2), 110-115

Dual-energy X-ray absorptiometry (DXA) devices from the three main manufacturers provide different bone mineral density (BMD) values, due in part to technical differences in the algorithms for bone ... [more ▼]

Dual-energy X-ray absorptiometry (DXA) devices from the three main manufacturers provide different bone mineral density (BMD) values, due in part to technical differences in the algorithms for bone mineral content (BMC) and area measurements and in part to the use of different manufacturer-derived reference databases. As a result, significant differences exist between Hologic, Lunar and Norland systems in the reported young normal standard deviation scores or T-scores. In a number of European countries, including Belgium, a T-score below -2.5 is one of the key criteria for reimbursement of osteoporosis treatments. This paper addresses the first attempt to implement a nationwide, uniform expression of BMD in patients, in order to harmonize drug reimbursement. To this end, measures were taken to implement a uniform expression of BMD in Belgian patients, by converting each manufacturer's absolute BMD to standardized BMD (sBMD) values and by establishing a single national reference range. [less ▲]

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See detailLong-term efficacy of risedronate: a 5-year placebo-controlled clinical experience
Sorensen, O. H.; Crawford, G. M.; Mulder, H. et al

in BONE (2003), 32(2), 120-126

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year ... [more ▼]

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization, with maintenance of blinding. End points included vertebral and nonvertebral fracture assessments, bone mineral density measurements, and changes in biochemical markers of bone turnover. A total of 265 women (placebo, 130; 5 mg risedronate, 135) entered the study extension and 220 (83%) completed the additional 2 years. Fracture results observed in the study extension were consistent with those observed in the first 3 years. The risk of new vertebral fractures was significantly reduced with risedronate treatment in years 4 and 5 by 59% (95% confidence interval, 19 to 79%, P = 0.01) compared with a 49% reduction in the first 3 years. Rapid and significant decreases in markers of bone turnover observed in the first 3 years were similarly maintained in the next 2 years of treatment. Increases in spine and hip bone mineral density that occurred in the risedronate group during the first 3 years were maintained or increased with a further 2 years of treatment. The mean increase from baseline in lumbar spine BMD over 5 years was 9.3% (P < 0.001). This study demonstrates that the effects of risedronate over 3 years on vertebral fracture and BMD are maintained with a further 2 years of treatment. (C) 2003 Elsevier Science (USA). All rights reserved. [less ▲]

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See detailis there any rationale for prescribing hormone replacement therapy (HTR) to prevent or to treat osteoarthritis?
Reginster, Jean-Yves ULg; Kvasz, Angela ULg; Bruyère, Olivier ULg et al

in Osteoarthritis and Cartilage (2003), 11(2), 87-91

Background: During the last two decades of the 20th century, hormone replacement therapy (HRT) has been considered as the sole pharmacological approach for counterbalancing or mitigating the effects of ... [more ▼]

Background: During the last two decades of the 20th century, hormone replacement therapy (HRT) has been considered as the sole pharmacological approach for counterbalancing or mitigating the effects of estrogens deprivation in post-menopausal women. Subsequently, HRT has been widely recommended for the management of chronic diseases occurring, in women during the second half of their life. The overall risk/benefit ratio of estrogens has been recently reassessed in the light of long-term prospective studies failing to demonstrate the expected benefit of HRT on cardiovascular diseases incidence. Osteoarthritis (OA) is one of the chronic conditions for which HRT has been suggested to provide beneficial outcomes. Results: The presence of estrogen receptors in human cartilage is no longer debated. However, cellular or animal models of OA do not provide an unequivocal pathway for the influence of gonadal steroids on cartilage. Similarly, studies attempting to correlate serum or urinary levels of sex steroids to the onset or progression of OA gave conflicting results. No randomized, prospective, controlled trial was designed to specifically assess the impact of hormone replacement therapy on symptomatic or structural progression of OA. Large-scale observational studies or trials designed to assess other potential benefits of estrogens suggest that HRT use does not provide symptomatic relief in OA but may interfere with its long-term structural progression, particularly in the lower limbs. Conclusion: Based on the recent results of the Women Health Initiative suggesting that HRT health risks may outweigh benefits, one can hardly recommend, with the current level of evidence, HRT as a first-line treatment against progression of OA. (C) 2003 OsteoArthritis Research Society International. Published by Elsevier Science Ltd. All rights reserved. [less ▲]

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See detailCorrelation between radiographic severity of knee osteoarthritis and future disease progression. Results from a 3-year prospective, placebo-controlled study evaluating the effect of glucosamine sulfate.
Bruyère, Olivier ULg; Honore, Aline; Ethgen, Olivier ULg et al

in Osteoarthritis and Cartilage (2003), 11(1), 1-5

OBJECTIVE: To investigate the relationship between baseline radiographic severity of knee osteoarthritis (OA) and the importance of long-term joint space narrowing. DESIGN: Sub-analysis from a three-year ... [more ▼]

OBJECTIVE: To investigate the relationship between baseline radiographic severity of knee osteoarthritis (OA) and the importance of long-term joint space narrowing. DESIGN: Sub-analysis from a three-year randomized, placebo-controlled, prospective study, of 212 patients with knee OA, recruited in an osteoarthritic outpatient clinic and having been part of a study evaluating the effect of glucosamine sulfate on symptom and structure modification in knee OA. MATERIAL AND METHODS: Measurements of mean joint space width (JSW), assessed by a computer-assisted method, were performed at baseline and after 3 years, on weightbearing anteroposterior knee radiographs. RESULTS: In the placebo group, baseline JSW was significantly and negatively correlated with the joint space narrowing observed after 3 years (r=-0.34, P=0.003). In the lowest quartile of baseline mean JSW (<4.5mm), the JSW increased after 3 years by (mean (S.D.)) 3.8% (23.8) in the placebo group and 6.2% (17.5) in the glucosamine sulfate group. The difference between the two groups in these patients with the most severe OA at baseline was not statistically significant (P=0.70). In the highest quartile of baseline mean JSW (>6.2mm), a joint space narrowing of 14.9% (17.9) occurred in the placebo group after 3 years while patients from the glucosamine sulfate group only experienced a narrowing of 6.0% (15.1). Patients with the most severe OA at baseline had a RR of 0.42 (0.17-1.01) to experience a 0.5mm joint space narrowing over 3 years, compared to those with the less affected joint. In patients with mild OA, i.e. in the highest quartile of baseline mean JSW, glucosamine sulfate use was associated with a trend (P=0.10) towards a significant reduction in joint space narrowing. CONCLUSION: These results suggest that patients with the less severe radiographic knee OA will experience, over 3 years, the most dramatic disease progression in terms of joint space narrowing. Such patients may be particularly responsive to structure-modifying drugs. [less ▲]

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See detailDégradation du cartilage et stress oxydatif chez des patients arthrosiques et souffrant d'arthrite rhumatoide
Deberg, Michelle; Labasse, A; Christgau, S et al

in Revue du Rhumatisme (2003), 70

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See detailEffet de la pression partielle en oxygène sur le métabolisme des chondrocytes bovins en culture
Burton, S; Mathy-Hartet, M; Dupont, G et al

in Revue du Rhumatisme (2003), 70

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See detailLes insaponifiables d'avocats/soja s'opposent aux effets délétères d'H2O2 sur le métabolisme du cartilage
Mathy-Hartet, Marianne; Devel, P; Piccardi, N et al

in Revue du Rhumatisme (2003), 70

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See detailOnce weekly alendronate produces a greater increase in bone mineral density than daily risedronate
Hosking, D; Adami, S; Felsenberg, D et al

in Calcified Tissue International (2003), 72

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See detailFracture prevention in postmenopausal women.
Bruyère, Olivier ULg; Edwards, John; Reginster, Jean-Yves ULg

in Clinical Evidence (2003), 9

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See detailComparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised, placebo-controlled study
Hosking, D.; Adami, S.; Felsenberg, D. et al

in Current Medical Research & Opinion (2003), 19(5), 383-394

Objective: To compare the effects of alendronate (ALN) 70 mg once weekly (OW) and risedronate (RIS) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in ... [more ▼]

Objective: To compare the effects of alendronate (ALN) 70 mg once weekly (OW) and risedronate (RIS) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density (BMD) in postmenopausal women with osteoporosis. Research design and methods: This was a 3-month, randomised, double-blind, placebo-controlled study with a double-blind extension to 12 months. The study enrolled 549 postmenopausal women (ALN 219, RIS 222 and placebo (PBO) 108) who were : 60 years of age at outpatient centres. Main outcome measures: The primary endpoint was reduction in urine N-telopeptides of type 1 collagen (NTx) corrected for creatinine level at 3 months. Secondary parameters included change in BMD at the spine and hip at 6 and 12 months, NTx at 1, 6 and 12 months, and serum bone-specific alkaline phosphatase (BSAP) at 1, 3, 6 and 12 months. Adverse experiences (AEs) were recorded throughout the study for an assessment of treatment safety profiles and tolerability. Results: Over 3 months, ALN produced a significantly greater mean reduction in urine NTx than did RIS (-52% vs -32%, p < 0.001), which was maintained at 12 months. ALN produced a significantly greater mean BMD increase than did RIS at 6 months, and it was maintained at 12 months at the lumbar spine (4.8% vs 2.8%, p < 0.001) and total hip (2.7% vs 0.9%, p < 0.001), as well as at the trochanter and femoral neck. Significant reductions in BSAP with ALN compared to RIS were maintained over the 12 months of treatment. Study size did not allow for meaningful assessment of differences in fracture rates. Tolerability was generally similar between ALN, RIS and PBO, and the incidence of upper GI AEs causing discontinuation and oesophageal AEs was similar in the ALN and RIS groups. Conclusion: In this study, ALN 70 mg OW produced a 50% greater reduction in bone resorption as measured by urine NTx and significantly greater increases in lumbar spine and hip BMD than did RIS 5 mg daily. The treatments had similar safety profiles and were generally well-tolerated. Additional studies are needed comparing OW ALN with OW RIS, which became available after the commencement of the present study. [less ▲]

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See detailKorean experience with the OSTA risk index for osteoporosis: a validation study.
Park, H. M.; Sedrine, W Ben; Reginster, Jean-Yves ULg et al

in Journal of Clinical Densitometry : The Official Journal of the International Society for Clinical Densitometry (2003), 6(3), 247-50

The Osteoporosis Self-assessment Tool for Asians (OSTA) was developed to help physicians focus their efforts on patients at increased risk, and encourage appropriate use of bone mineral density (BMD ... [more ▼]

The Osteoporosis Self-assessment Tool for Asians (OSTA) was developed to help physicians focus their efforts on patients at increased risk, and encourage appropriate use of bone mineral density (BMD) measurements. Previously, OSTA performed well in a sample of women from eight countries in Asia, and in a validation group of Japanese women. In this study, we evaluate the performance of OSTA using a sample of 1101 postmenopausal women from a clinic in Korea who had femoral neck BMD measurements by dual-energy X-ray absorptiometry (DXA). The OSTA had a high sensitivity (87%), and good specificity (67%) for identifying osteoporosis (BMD T-scores <or= -2.5); the corresponding values were 80% and 72% for identifying T-scores <or= -2.0. The prevalence of osteoporosis ranged from 2% among women classified as low risk (OSTA > -1) to 64% among those classified as high risk (OSTA < -4); these results were almost identical to those reported earlier for a sample of women from eight Asian countries. We conclude that the OSTA risk tool performed well in this sample of postmenopausal Korean women, similar to previous results in other Asian women. The OSTA tool is free and very easy to use; risk can be tabulated by age and weight, so that calculations are not necessary. Using OSTA could encourage patients and clinicians to actively assess osteoporosis, and measure BMD when appropriate, before fractures occur. [less ▲]

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