Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

NCT ID: NCT00772395

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Risedronate

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Interventions

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Risedronate

35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Intervention Type DRUG

Placebo

Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olof Skoldenberg

Consulatant Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olof G Sköldenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Department of clinical sciences at Danderyd hospital

Locations

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Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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04-745/4

Identifier Type: -

Identifier Source: secondary_id

04-745/4

Identifier Type: -

Identifier Source: org_study_id

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