To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study...
Date First Received: December 12, 2005
Last Updated: February 26, 2008
Verified by: Kaohsiung Medical University Chung-Ho Memorial Hospital, April 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 60
Brief Summary
Official Title: “Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis”
Condition Keyword(s):
Intervention(s):
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: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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 Sponsor Information
Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
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 October 06, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
