Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomized, double-blind, placebo-controlled trial

Cooper, Cyrus, Reginster, Jean-Yves, Chapurlat, Roland, Christiansen, Claus, Genant, Harry, Bellamy, Nicholas, Bensen, William, Navarro, Federico, Badurski, Janusz, Nasonov, Evgeny, Chevalier, Xavier and Sambrook, Philip N. (2011) Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomized, double-blind, placebo-controlled trial. Current Medical Research And Opinion, 28 2: 231-239. doi:10.1185/03007995.2011.648758


Author Cooper, Cyrus
Reginster, Jean-Yves
Chapurlat, Roland
Christiansen, Claus
Genant, Harry
Bellamy, Nicholas
Bensen, William
Navarro, Federico
Badurski, Janusz
Nasonov, Evgeny
Chevalier, Xavier
Sambrook, Philip N.
Title Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomized, double-blind, placebo-controlled trial
Journal name Current Medical Research And Opinion   Check publisher's open access policy
ISSN 0300-7995
1473-4877
Publication date 2011-01-01
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1185/03007995.2011.648758
Volume 28
Issue 2
Start page 231
End page 239
Total pages 36
Place of publication London, United Kingdom
Publisher Informa Healthcare
Collection year 2012
Language eng
Formatted abstract
Objective
The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trials report that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical
symptoms of spinal osteoarthritis, suggesting symptom- and structuremodifying activity in osteoarthritis. We describe the rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.

Research design, methods, and results

This double-blind, placebo-controlled trial (98 centres, 18 countries) includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibio-femoral compartment [Kellgren and Lawrence grade 2 or 3], joint space width (JSW) 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale). Patients are randomly allocated to three groups (strontium ranelate 1 or 2 g/day, or placebo). Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint was WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years). Recruitment started in April 2006. The results are expected in spring 2012.

Clinical trial registration
The trial is registered on www.controlled-trials.com (number ISRCTN41323372).

Conclusions

This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.

Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Online: 8 December 2011

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2012 Collection
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 24 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 20 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Thu, 15 Dec 2011, 01:00:58 EST by Chesne McGrath on behalf of Medicine - Royal Brisbane and Women's Hospital