Bone Loss
Conditions
Keywords
Periprosthetic bone loss risedronate bisphosphonates
Brief summary
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?
Detailed description
Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.
Interventions
DRUGRisedronate
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
DRUGPlacebo
Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Sponsors
Sanofi
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients on the waiting list for a total hip arthroplasty * Primary osteoarthritis * Osteoarthritis secondary to congenital dislocation of the hip
Exclusion criteria
* Rheumatoid arthritis * Bisphosphonate treatment * Osteomalacia * Hypocalcemia * Previous surgery of the affected hip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Can risedronate reduce migration of a uncemented femoral stem | 4 years |
Countries
Sweden
Outcome results
None listed