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: OSTEOARTHRITIS; MedDRA version: 14.1Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2005-002494-75-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

Caucasian men and women aged > or equal 50 years; primary knee osteoarthritis of the medial femoro-tibial ompartment; under effective contraceptive method for non-menopausal women; ambulatory (able to walk unassisted); capable of understanding the study, capable of reading and writing; patients having given informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Exclusion Criteria

Condition depending on the patient (detailed in the study protocol); significant medical history or concomitant diseases (detailed in study protocol); previous treatments likely to have actions on cartilage metabolism (detailed in study protocol); previous treatments which could compromise the clinical functional and pain assessment (detailed in study protocol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate the superiority of strontium ranelate (1g and 2 g per day) versus placebo against articular cartilage damage progression over two years in men and women with knee osteoarthritis.;Secondary Objective: to assess the effects of strontium ranelate (1g and 2g per day) versus placebo on the other efficacy end-points and its safety, in addition to the effects on concomitant OA of the hip, of the hands and on subchondral bone microarchitecture;Primary end point(s): radiographic progression of knee osteoarthritis: