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Randomized Controlled Trial
, 7 (3), R625-33

Effect of Risedronate on Joint Structure and Symptoms of Knee Osteoarthritis: Results of the BRISK Randomized, Controlled Trial [ISRCTN01928173]

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Randomized Controlled Trial

Effect of Risedronate on Joint Structure and Symptoms of Knee Osteoarthritis: Results of the BRISK Randomized, Controlled Trial [ISRCTN01928173]

Tim D Spector et al. Arthritis Res Ther.

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 >or= 25% or >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.

Figures

Figure 1
Figure 1
Disposition of patients with knee osteoarthritis in a controlled, randomized trial of risedronate.
Figure 2
Figure 2
Changes in mean values at 12 months from baseline measures in patients with osteoarthritis. Patients were given risodronate (Ris) or placebo. Scores were the weighted composite of the 24 question scores on the visual analogue scale (1 to 100 mm) of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index or its subscales for pain, stiffness, and physical function. Vertical lines represent standard errors of the mean. P values refer to risedronate (15 mg) vs baseline values.
Figure 3
Figure 3
Changes in mean patient global assessment after risedronate or placebo in osteoarthritis. Vertical lines represent standard errors of the mean. Ris, risedronate.
Figure 4
Figure 4
Relation between WOMAC scores and minimum percentage change in JSW after 1 year in patients with osteoarthritis. Scores were the weighted composite (1 to 100 mm) of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index or its subscales for pain and physical function. JSW, joint-space width.
Figure 5
Figure 5
Changes in urinary CTX-II levels after treatment of osteoarthritis patients with placebo or risedronate. Ris, risedronate.

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