Overview

This trial is active, not recruiting.

Condition bone loss
Treatments risedronate, placebo
Phase phase 4
Sponsor Danderyd Hospital
Collaborator Sanofi
Start date April 2006
End date October 2008
Trial size 78 participants
Trial identifier NCT00772395, 04-745/4

Summary

Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
risedronate
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
(Placebo Comparator)
placebo
Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Primary Outcomes

Measure
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty
time frame: 2 years

Secondary Outcomes

Measure
Can risedronate reduce migration of a uncemented femoral stem
time frame: 2 years

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
Principal investigator Olof G Sköldenberg, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Danderyd Hospital.