The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 3 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.
- Conditions
- OsteoarthritisMedDRA version: 7.0Level: PTClassification code 10031161
- Registration Number
- EUCTR2005-002494-75-AT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1680
- Caucasian men and women aged = 50 years,
- Primary knee osteoarthritis of the medial femoro-tibial compartment,
- Under effective contraceptive method for non-menopausal women (for Austria: only postmenopausal women),
- Ambulatory (able to walk unassisted),
- Capable of understanding the study, capable of reading and writing,
- Patients having given written informed consent for this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Conditions depending on the patient (detailed in the study protocol)
- Significant medical history or concomitant diseases (detailed in the study protocol)
- Previous treatments likely to have actions on cartilage metabolism (detailed in the study protocol)
- Previous treatments which could compromise the clinical assessment (detailed in the study protocol).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method