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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002494-75-DE
Enrollment
1680
Registered
2005-12-07
Start date
2006-04-26
Completion date
Unknown
Last updated
2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis MedDRA version: 7.0 Level: PT Classification code 10031161

Interventions

Product Name: S12911 Product Code: S12911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: strontium ranelate CAS Number: 135459-90-4 Current Sponsor code: S 12911-2 Concentratio

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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 Germany: 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

Exclusion criteria

Exclusion criteria: - 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).

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression;Secondary Objective: To assess the effects of strontium ranelate versus placebo on the other efficacy end-points and its safety. ;Primary end point(s): Radiographic progression of knee osteoarthritis—

Countries

Czech Republic, Estonia, Germany, Italy, Lithuania, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026