Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study...
Brief Summary
Official Title: “Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis”
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial Description
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
Intervention(s) in this Clinical Trial
- Drug: Alendronate
Outcome Measures for this Clinical Trial
Primary Measures
- the cumulative of total hip replacement
Secondary Measures
- necrotic area
- Harris hip score
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Kaohsiung Medical University Chung-Ho Memorial Hospital Other
Overall Clinical Trial Officials and Contacts
Gwo-Jaw Wang, MD Study Chair Kaohsiung Medical University
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00265252
Study ID Number: fosamax 01
ClinicalTrials.gov Identifier: NCT00265252
Health Authority: Taiwan: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00265252
