An international study to assess the effects of strontium ranelate in the reduction of bone loss around the metal implant, in patients with hip prosthesis
Not Applicable
Completed
- Conditions
- Periprosthetic bone loss / total hip arthroplastyMusculoskeletal DiseasesPeriprosthetic bone loss
- Registration Number
- ISRCTN15928978
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
1. Caucasian male or postmenopausal women
2. Age less than or equal to 50 years
3. Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication for total hip arthroplasty
Exclusion Criteria
1. Short femoral stem
2. Any perioperative complication
3. Patient with inflammatory arthropathy
4. Impossibility to perform Dual-emission X-ray absorptiometry (DXA)
5. Increase risk or history of venous thromboembolism (VTE)
6. Known hypersensitivity or contraindication to the study drug or Calperos D3®
7. Concomittant treatments likely to interfere with bone metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relative change of periprosthetic bone mineral density (BMD) in region 7 of Gruen after total hip arthroplasty over 12 months
- Secondary Outcome Measures
Name Time Method <br> 1. The relative change of other regions of Gruen over 12 months<br> 2. Safety over 12 months<br>