ong-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.

• Conditions: Osteoarthritis; MedDRA version: 9.0Level: PTClassification code 10031161

• Registration Number: EUCTR2006-004194-10-BE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-19
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Caucasian males or females,
- Aged 45 years or over,
- Primary knee osteoarthritis based on clinical and radiological criteria (detailed in the study protocol),
- Under an effective contraceptive method for non-menopausal women,
- Ambulatory (able to walk unassisted).

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

Exclusion Criteria

- Knee prosthesis already implanted, or foreseen within the next year,
- Hip prosthesis already implanted (<1 year) or not well-tolerated or foreseen within the next year,
- Previous osteotomy on the inferior limbs,
- Other: 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
Main Objective: To assess the effectiveness of a 2-year treatment with strontium ranelate on algofunctional symptoms of knee osteoarthritis, compared to placebo.;Secondary Objective: ;Primary end point(s): Changes in the algofunctional behaviour of the target knee (measured in the lequesne index).