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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Merck
National Cheng-Kung University Hospital
National Taiwan University Hospital
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00265252
First received: December 12, 2005
Last updated: February 26, 2008
Last verified: April 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Non-Traumatic Osteonecrosis
 Drug: Alendronate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • the cumulative of total hip replacement

Secondary Outcome Measures:
  • necrotic area
  • Harris hip score

Estimated Enrollment: 60
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
Detailed 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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265252

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Merck
National Cheng-Kung University Hospital
National Taiwan University Hospital
Investigators
Study Chair: Gwo-Jaw Wang, MD Kaohsiung Medical University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00265252     History of Changes
Other Study ID Numbers: fosamax 01
Study First Received: December 12, 2005
Last Updated: February 26, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
osteonecrosis
total hip replacement

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
 Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013