Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

Bone Loss Clinical Trial

— PREVENT  

Official title:

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772395
• Other study ID #: 04-745/4
• Secondary ID: 04-745/4
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2008
• Last updated: September 18, 2014
• Start date: April 2006
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss

Intervention

Drug:
• Risedronate
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
• Placebo
Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Locations

Country	Name	City	State
Sweden	Orthopaedic department, Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Sanofi

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty		4 years	No
Secondary	Can risedronate reduce migration of a uncemented femoral stem		4 years	No