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See detailThe role of diet and exercise and of glucosamine sulfate in the prevention of knee osteoarthritis: Further results from the PRevention of knee Osteoarthritis in Overweight Females (PROOF) study.
Runhaar, J.; DEROISY, Rita ULg; van Middelkoop, M. et al

in Seminars in Arthritis & Rheumatism (2016), 45(4 Suppl), 42-48

Background and objectives: The PRevention of knee Osteoarthritis in Overweight Females(PROOF) study (ISRCTN42823086) described a trend for a decrease in the incidence of kneeo steoarthritis (OA) by a ... [more ▼]

Background and objectives: The PRevention of knee Osteoarthritis in Overweight Females(PROOF) study (ISRCTN42823086) described a trend for a decrease in the incidence of kneeo steoarthritis (OA) by a tailored diet and exercise program (DEP)or by oral glucosamine sulfate in women at risk for the disease, using a composite clinical and/or radiological outcome. The aim of this updated post-hoc analysis was to re-assess the results according to more precise techniques and take advantage of the 2 x 2 factorial design. Methods: A total of 407 overweight( BMI > or egal 27kg/m2) women of 50–60 years of age with no diagnosis of knee OA were randomized to: (1) noDEP + placebo(Control, N = 102), (2) DEP + placebo (DEP, N = 101), (3) glucosamine sulfate + no DEP (GS, N = 102), and (4) DEP + glucosamine sulfate (DEP + GS, N = 102) and followed for 2.5 years, with standardized postero-anterior, semiflexed (MTP) view knee radiographs at baseline and end of the study. DEP consisted of a tailored low fat and/or low caloric diet and easy to implement physical activities. Glucosamine was given as oral crystalline glucosamine sulfate 1500 mg once daily ,double-blinded vs. placebo. Incident knee OA was defined as radiographic progression of >1mm minimum joint space narrowing (mJSN)in the medial tibiofemoral compartment, as previously assessed by the visual (manual) technique and by a new semi-automated method. Logistic regression analysis was used t ocalculate the odds ratio for the effect of the interventions. Results: After 2.5 years, 11.8% of control subjects developed knee OA. This incidence was decreased with glucosamine sulfate, either alone or in combination with the DEP, but not by the DEP alone. Since there was no statistical interaction between treatments, the 2x2 factorial design allowed analysis of patients receiving glucosamine sulfate (N = 204) vs. those not receiving it (N= 203), similarly for those on the DEP (N = 203) or not (N = 204). Glucosamine sulfate significantly decreased the risk of developing knee OA: odds ratio (OR) = 0.41(95% CI: 0.20–0.85, P = 0.02) by the manual JSN assessment method and OR = 0.42 (95% CI:0.20–0.92, P =0.03) by the semi-automated technique. Conversely, there was no decrease in risk with the DEP. Conclusions: Glucosamine sulfate decreased the risk of developing radiographic knee OA over 2.5 years in overweight, middle-aged women at risk, as determined by medial mJSN progression. Conversely a tailored diet and exercise program exerted no preventive effect, possibly because of the lower than expected effect on weigh tloss. [less ▲]

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See detailAssessment of joint space narrowing with conventional standing antero-posterior radiographs: relief in mild-to-moderate pain is not a confounder in recent osteoarthritis structure-modifying drug trials
Rovati, L. C.; Pavelka, K.; Giacovelli, G. et al

in Osteoarthritis and Cartilage (2006), 14(Suppl. A), 14-18

Objective: Knee pain relief has been suggested to potentially alter radioanatomic positioning in conventional standing antero-posterior knee radiographs. This study was performed to determine whether this ... [more ▼]

Objective: Knee pain relief has been suggested to potentially alter radioanatomic positioning in conventional standing antero-posterior knee radiographs. This study was performed to determine whether this is always the case and in particular if it applied to two recent randomised, placebo-controlled trials showing both symptom- and structure-modification with glucosamine sulfate in knee osteoarthritis. Design: Patients in the two studies were selected if they completed the 3-year evaluations and, irrespectively of treatment, (1) were pain-improvers in that they underwent Western Ontario and McMaster Universities (WOMAC) osteoarthritis index (WOMAC) pain decrease at least equal to the mean improvement observed with glucosamine sulfate, or (2) if their baseline standing knee pain (item #5 of the WOMAC pain scale) was "severe" or "extreme" and improved by any degree at the end of the trials. Changes in minimum joint space width were then compared between treatments. Results: Knee pain was of mild-to-moderate severity in the two original studies and in all patient subsets identified here. Obviously, there were more pain-improvers in the glucosamine sulfate than in the placebo subsets (N 76 vs 57 in pooling the two studies), but WOMAC pain scores improved to the same extent (over 50% relative to baseline). Notwithstanding such a major pain relief, patients in the placebo subsets of both studies suffered a definite mean (SE) joint space narrowing, that was of -0.22 (0.15) mm in the pooled analysis, and that was not observed with glucosamine sulfate: +0.15 (0.07) mm; P= 0.003. Similar evidence was found in the smaller subsets with at least severe baseline standing knee pain improving after 3 years. Conclusions: Knee pain relief did not bias the report of a structure-modifying effect of glucosamine sulfate in two recent long-term trials, possibly due to the mild-to-moderate patient characteristics. Consensus deliverables should acknowledge that the potential limitations of conventional standing antero-posterior radiographs should not be overestimated since they may not apply to all patient populations and to all studies using this gold standard technique. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved. [less ▲]

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See detailClinical relevance of pain and function outcomes in glucosamine sulfate long-term trials
Giacovelli, G.; Bruyère, Olivier ULg; Barbetta, B. et al

in Osteoarthritis and Cartilage (2005), 13(A), 69

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See detailResponders to glucosamine sulfate in knee osteoarthritis
Bruyère, Olivier ULg; Pavelka, K.; Richy, F. et al

in Osteoporosis International (2004), 12(SB), 76

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See detailPain relief is not a confounder in joint space narrowing assessment of full extension knee radiographs
Pavelka, K.; Rovati, L. C.; Gatterova, J. et al

in Osteoarthritis and Cartilage (2002), 10(SA), 16-17

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See detailSodium monofluorophosphate reduces vertebral fractures in moderate postmenopausal osteoporosis
Reginster, Jean-Yves ULg; Meurmans, L; Zegels, Brigitte ULg et al

in Journal of Bone and Mineral Research (1997), 12(S1), 104

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See detailSodium monofluorophosphate reduces fracture incidence in women with postmenopausal osteoporosis : a randomized, placebo-controlled, double-blind study
Meurmans, L; Zegels, Brigitte ULg; Rovati, LC et al

in Revue du Rhumatisme (English ed.) (1996), 63

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See detailEfficacy and safety of monofluorophosphate and calcium in postmenopausal osteoporosis
Reginster, Jean-Yves ULg; Zegels, Brigitte ULg; Meurmans, L et al

in Revista Espanola de Reumatologia : Organo Oficial de la Sociedad Espanola de Reumatologia (1993), 20(S1), 186

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