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Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial
  1. Jean-Yves Reginster1,
  2. Janusz Badurski2,
  3. Nicholas Bellamy3,
  4. William Bensen4,
  5. Roland Chapurlat5,
  6. Xavier Chevalier6,
  7. Claus Christiansen7,
  8. Harry Genant8,
  9. Federico Navarro9,
  10. Evgeny Nasonov10,
  11. Philip N Sambrook11,
  12. Timothy D Spector12,
  13. Cyrus Cooper13
  1. 1Department of Public Health Epidemiology and Health Economics, University of Liege, Liege, Belgium
  2. 2Centre of Osteoporosis and Osteoarticular Diseases, Bialystok, Poland
  3. 3Centre of National Research on Disability (CONROD), University of Queensland, Herston, Queensland, Australia
  4. 4DeGroot School of Medicine, McMaster University Hamilton, Hamilton, Ontario, Canada
  5. 5INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Hôpital Edouard Herriot, Université de Lyon, Lyon, France
  6. 6Service de Rhumatologie, Hôpital Henri Mondor, Créteil, France
  7. 7Synarc, Centre for Clinical and Basic Research (CCBR), Ballerup, Denmark
  8. 8Radiology, Medicine, Epidemiology and Orthopedic Surgery, University of California, San Francisco and Synarc, San Francisco, California, USA
  9. 9Rheumatology Department, Hospital Universitario Virgen Macarena, Sevilla, Spain
  10. 10State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian Federation
  11. 11Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards, NSW, Australia
  12. 12Department of Twin Research and Genetic Epidemiology, Kings College London, St Thomas’ Hospital, London, UK
  13. 13MRC Lifecourse Epidemiology Unit, NIHR Musculoskeletal Biomedical Research Unit, University of Southampton, University of Oxford, Oxford, UK
  1. Correspondence to Professor Jean-Yves Reginster, Department of Public Health and Health Economics, University of Liege, 4020 Liege, Belgium; jyreginster{at}ulg.ac.be

Abstract

Background Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.

Methods Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5–5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372).

Results The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: −0.23 (SD 0.56) mm; 2 g/day: −0.27 (SD 0.63) mm; placebo: −0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated.

Conclusions Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.

  • Knee Osteoarthritis
  • Osteoarthritis
  • Outcomes research

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