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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004194-10-BE
Enrollment
Unknown
Registered
2006-10-19
Start date
2006-11-07
Completion date
Unknown
Last updated
2014-10-07

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

Conditions

Osteoarthritis MedDRA version: 9.0 Level: PT Classification code 10031161

Interventions

Trade Name: PROTELOS 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

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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).—

Countries

Belgium

Outcome results

None listed

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