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

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ClinicalTrials.gov Identifier: NCT00265252
Recruitment Status : Unknown
Verified April 2007 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 14, 2005
Last Update Posted : February 27, 2008
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
National Cheng-Kung University Hospital
National Taiwan University Hospital
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Non-Traumatic Osteonecrosis Drug: Alendronate Phase 4

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Study Start Date : June 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. the cumulative of total hip replacement

Secondary Outcome Measures :
  1. necrotic area
  2. Harris hip score


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265252


Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Merck Sharp & Dohme Corp.
National Cheng-Kung University Hospital
National Taiwan University Hospital
Investigators
Study Chair: Gwo-Jaw Wang, MD Kaohsiung Medical University

Publications:
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
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: February 27, 2008
Last Verified: April 2007

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