Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty - Full Text View

Sponsors and Collaborators:	Danderyd Hospital Sanofi-Aventis
Information provided by:	Danderyd Hospital
ClinicalTrials.gov Identifier:	NCT00772395

Purpose

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

Condition	Intervention	Phase
Bone Loss	Drug: Risedronate Drug: Placebo	Phase IV

Drug Information available for: Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Can risedronate reduce migration of a uncemented femoral stem [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	78
Study Start Date:	April 2006
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Risedronate: Active Comparator	Drug: Risedronate 35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Placebo: Placebo Comparator	Drug: Placebo Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772395

Locations

Sweden
Orthopaedic department, Danderyd Hospital
Stockholm, Sweden, 18288

Sponsors and Collaborators

Danderyd Hospital

Sanofi-Aventis

Investigators

Principal Investigator:

Olof G Sköldenberg, MD

Department of Clinical Sciences at Danderyd Hospital

More Information

Responsible Party:	Danderyd Hospital ( Olof Sköldenberg )
Study ID Numbers:	04-745/4, 04-745/4
Study First Received:	October 14, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00772395
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Danderyd Hospital:

Periprosthetic bone loss risedronate bisphosphonates

Study placed in the following topic categories:

Calcium, Dietary
Diphosphonates
Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009