Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty (PREVENT)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT00772395
First received: October 14, 2008
Last updated: September 18, 2014
Last verified: September 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Resource links provided by NLM:


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: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Can risedronate reduce migration of a uncemented femoral stem [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: April 2006
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risedronate Drug: Risedronate
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Olof G Sköldenberg, MD Department of Clinical Sciences at Danderyd Hospital
  More Information

No publications provided

Responsible Party: Olof Skoldenberg, Consulatant Orthopaedic Surgeon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT00772395     History of Changes
Other Study ID Numbers: 04-745/4, 04-745/4
Study First Received: October 14, 2008
Last Updated: September 18, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Danderyd Hospital:
Periprosthetic bone loss risedronate bisphosphonates

Additional relevant MeSH terms:
Risedronic acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014