Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized,controlled trial [ISRCTN01928173] |
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Authors: | Email author" target="_blank">Tim?D?SpectorEmail author Philip?G?Conaghan J?Christopher?Buckland-Wright Patrick?Garnero Gary?A?Cline John?F?Beary David?J?Valent Joan?M?Meyer |
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Institution: | (1) Twin Research &; Genetic Epidemiology Unit, St Thomas' Hospital, London, UK;(2) Academic Unit of Musculoskeletal Disease, University of Leeds, UK;(3) School of Biomedical Sciences, King's College London, London, UK;(4) SYNARC, Lyon, France;(5) Procter &; Gamble Pharmaceuticals, Mason, OH, USA |
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Abstract: | To determine the efficacy and safety of risedronate in patients with knee osteoarthritis (OA), the British study of risedronate
in structure and symptoms of knee OA (BRISK), a 1-year prospective, double-blind, placebo-controlled study, enrolled patients
(40–80 years of age) with mild to moderate OA of the medial compartment of the knee. The primary aims were to detect differences
in symptoms and function. Patients were randomized to once-daily risedronate (5 mg or 15 mg) or placebo. Radiographs were
taken at baseline and 1 year for assessment of joint-space width using a standardized radiographic method with fluoroscopic
positioning of the joint. Pain, function, and stiffness were assessed using the Western Ontario and McMaster Universities
(WOMAC) OA index. The patient global assessment and use of walking aids were measured and bone and cartilage markers were
assessed. The intention-to-treat population consisted of 284 patients. Those receiving risedronate at 15 mg showed improvement
of the WOMAC index, particularly of physical function, significant improvement of the patient global assessment (P < 0.001), and decreased use of walking aids relative to patients receiving the placebo (P = 0.009). A trend towards attenuation of joint-space narrowing was observed in the group receiving 15 mg risedronate. Eight
percent (n = 7) of patients receiving placebo and 4% (n = 4) of patients receiving 5 mg risedronate exhibited detectable progression of disease (joint-space width ≥ 25% or ≥ 0.75
mm) versus 1% (n = 1) of patients receiving 15 mg risedronate (P = 0.067). Risedronate (15 mg) significantly reduced markers of cartilage degradation and bone resorption. Both doses of risedronate
were well tolerated. In this study, clear trends towards improvement were observed in both joint structure and symptoms in
patients with primary knee OA treated with risedronate. |
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