Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

NCT ID: NCT00265252

Last Updated: 2008-02-27

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

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To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid

Detailed Description

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To determine the cumulative incidence of total hip replacement and collpase of femoral head, time to event after treatment with Fosamax or placebo during the study peroid

Conditions

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Non-Traumatic Osteonecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Alendronate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* osteonecrosis of femoral head
* be able to provide singed informed consent

Exclusion Criteria

* prior bisphosphonate use
* pregnant or lactating woman
* bilateral hip replacement
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Gwo-Jaw Wang, MD

Role: STUDY_CHAIR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Lai KA, Shen WJ, Yang CY, Shao CJ, Hsu JT, Lin RM. The use of alendronate to prevent early collapse of the femoral head in patients with nontraumatic osteonecrosis. A randomized clinical study. J Bone Joint Surg Am. 2005 Oct;87(10):2155-9. doi: 10.2106/JBJS.D.02959.

Reference Type BACKGROUND
PMID: 16203877 (View on PubMed)

Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.

Reference Type DERIVED
PMID: 22127729 (View on PubMed)

Other Identifiers

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fosamax 01

Identifier Type: -

Identifier Source: org_study_id

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