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

Primary Purpose

Bone Loss

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Risedronate
Placebo
Sponsored by
Danderyd Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring Periprosthetic bone loss risedronate bisphosphonates

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopaedic department, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Risedronate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Can risedronate reduce migration of a uncemented femoral stem

Full Information

First Posted
October 14, 2008
Last Updated
September 18, 2014
Sponsor
Danderyd Hospital
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00772395
Brief Title
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Acronym
PREVENT
Official Title
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
Keywords
Periprosthetic bone loss risedronate bisphosphonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risedronate
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Can risedronate reduce migration of a uncemented femoral stem
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof G Sköldenberg, MD
Organizational Affiliation
Department of clinical sciences at Danderyd hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic department, Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden

12. IPD Sharing Statement

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Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

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