Can risedronate prevent periprosthetic bone loss after hip arthroplasty?A randomized, double-blind, placebo-controlled trial - PREVENT
Active, not recruiting
- Conditions
- Periprosthetic bone loss after total hip arthroplasty (THA) is the main factor in limiting the longevity of implants used för treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA may prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthetic loosening. We want to perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss.
- Registration Number
- EUCTR2004-002965-19-SE
- Lead Sponsor
- Orthopaedic department, Karolinska Institutet, Danderyd's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients waiting for total hip arthroplasty due to primary or secondary osteoarthritis of the hip.
Patients between 40-70 years of age.
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
Patients with rhematoid arthritis or earlier infection of the hip
Steroid treatment
Bisphosphonate treatment
Osteomalacia
Hypocalcemia
Pregnancy
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