Knee joint replacement follow up study in patients with knee osteoarthritis which participated to the CL3-12911-018 study.
- Conditions
- OsteoarthritisThe medical condition investigated in the CL3-12911-018 study was osteoarthritis. The applied CL3-12911-040 trial, CL3-12911-018 follow-up study, is thus performed in osteoarthritic patients.MedDRA version: 14.1Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-004046-18-PL
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1202
Patients included in the CL3-12911-018 study and having received the CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo) for at least one year (at least 365 days of treatment during the CL3-12911-018 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 772
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 434
- unlikely to cooperate in the study (such as patients suffering from dementia)
- patients unable to provide the information requested by the study
- refusal to provide the study's informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method