The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 2 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.

• Register: EUCTR
• Last refreshed on: 17 July 2012
• Main ID: EUCTR2005-002494-75-ES
• Date of registration: 16/01/2006
• Primary sponsor: Servier S.L.
• Public title: The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 2 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.
• Scientific title: The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 2 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study.
• Date of first enrolment: 27/02/2006
• Target sample size: 960
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002494-75
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no

Countries of recruitment

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

Key inclusion & exclusion 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,
- 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:
- 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Osteoarthritis
MedDRA version: 7.0 Level: PT Classification code 10031161

Intervention(s)

Trade Name: PROTELOS
Product Code: S 12911
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: strontium ranelate
CAS Number: 135459-90-4
Current Sponsor code: S 12911-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use

Product Code: S 12911
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: strontium ranelate
CAS Number: 135459-90-4
Current Sponsor code: S 12911-2
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Granules for oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression

Primary end point(s): Radiographic progression of knee osteoarthritis

Secondary Objective: To assess the effects of strontium ranelate versus placebo on the other efficacy end-points and its safety.

Secondary ID(s)

2005-002494-75-DE

CL3-12911-018