Background Strontium ranelate (SrRan) has potential beneficial effects on cartilage degradation in OA, stimulating human cartilage matrix formation in vitro and decreasing the urinary C-terminal telopeptides of type II-collagen. SrRan has also been shown to reduce radiographic spinal OA progression and back pain in osteoporotic women with prevalent spinal OA.
Objectives We compared the efficacy and safety of SrRan with placebo in the treatment of knee osteoarthritis in a double-blind, placebo-controlled, randomised, international study (registration number: ISRCTN41323372) designed in accordance with the European Guidelines.
Methods Patients with primary knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, joint space width (JSW) 2.5 to 5 mm, and knee pain intensity of at least 40 mm on a visual analogue scale during the month prior to selection, were randomly allocated to SrRan 1 or 2 g/day, or placebo using a centralised interactive voice response system. The primary endpoint was radiographic joint space narrowing measured as the mean change in the minimal JSW of the knee medial tibiofemoral compartment with a semiautomated centralised reading method. JSW was measured at inclusion, 12, 24, and 36 months on radiographs with a postero-anterior, weight-bearing, fixed-flexion acquisition technique. Main secondary endpoints were changes in algofunctional scores (WOMAC), changes in knee pain intensity, and proportion of radiological progressors (patients with knee JSN>0.5 mm). Safety was assessed by adverse events and haematology/biochemistry/haemostasis parameters.
Results Detailed results will be presented. The patients were included in 113 centres in 18 countries. 558 patients were assigned to SrRan 1 g/day, 566 to 2 g/day, and 559 to placebo. Mean follow-up was 29.8±10.5 months. Mean age was 62.8±7.2 years and 69% were female. Mean BMI was 30±5 kg/m2, mean JSW was 3.50±0.83 mm, and 61% of randomised patients were Kellgren and Lawrence stage II.
Conclusions This large randomised placebo-controlled study will establish the long-term efficacyof SrRan on structure and symptoms in patients with knee osteoarthritis.
Disclosure of Interest None Declared
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