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

This study has been completed.
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital Identifier:
First received: October 14, 2008
Last updated: September 18, 2014
Last verified: September 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Can risedronate reduce migration of a uncemented femoral stem [ Time Frame: 4 years ]

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.

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00772395

Orthopaedic department, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Principal Investigator: Olof G Sköldenberg, MD Department of clinical sciences at Danderyd hospital
  More Information

Responsible Party: Olof Skoldenberg, Consulatant Orthopaedic Surgeon, Danderyd Hospital Identifier: NCT00772395     History of Changes
Other Study ID Numbers: 04-745/4
Study First Received: October 14, 2008
Last Updated: September 18, 2014

Keywords provided by Danderyd Hospital:
Periprosthetic bone loss risedronate bisphosphonates

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017