Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.

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.

• Authors: Jean-Yves Reginster, Janusz Badurski, Nicholas Bellamy, William Bensen, Roland Chapurlat, Xavier Chevalier, Claus Christiansen, Harry Genant, Federico Navarro, Evgeny Nasonov, Philip N Sambrook, Timothy D Spector, Cyrus Cooper
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 72 Issue 2 Pg. 179-86 (Feb 2013) ISSN: 1468-2060 [Electronic] England
• PMID: 23117245 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Organometallic Compounds
• Thiophenes
• strontium ranelate

Topics

• Aged
• Antirheumatic Agents (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Organometallic Compounds (therapeutic use)
• Osteoarthritis, Knee (diagnostic imaging, drug therapy)
• Radiography
• Thiophenes (therapeutic use)
• Treatment Outcome