Efficacy of strontium ranelate in the reduction of bone loss around the metal implants in patients after hip replacement surgery.
Phase 1
- Conditions
- Reduction of periprosthetic bone loss in patients with total hip arthoplasty for coxarthrosisMedDRA version: 14.1Level: PTClassification code 10052306Term: Periprosthetic osteolysisSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-020215-36-BE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
Caucasian men or postmenopausal women,
Age = 50 years,
Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication of total hip arthroplasty.
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88
Exclusion Criteria
Short femoral stem,
Any perioperative complication,
Patients with inflammatory arthropathy,
Impossibility to perform DXA,
Increased risk or history of VTE,
Known hypersensitivity or contraindication to the study drug or Calperos D3®.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in region 7 of Gruen, over 12 months of treatment after total hip arthroplasty.;Secondary Objective: To show the efficacy of strontium ranelate versus placebo in the reduction of periprosthetic bone loss in proximal and total regions of interest and in region 1 to 6 of Gruen, over 12 months of treatment. <br>To assess the efficacy of strontium ranelate versus placebo on the same criteria described above over 6 months of treatment.<br>To assess the safety of strontium ranelate over 12 months of treatment.<br>;Primary end point(s): The relative change of periprosthetic BMD in region 7 of Gruen after total hip arthroplasty.;Timepoint(s) of evaluation of this end point: Evaluation of change over 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The relative change of other regions of Gruen.<br>Safety<br>;Timepoint(s) of evaluation of this end point: Relative change from baseline to 6 and 12 months<br>Safety measurement over 12 months<br>