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

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Double

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

Interventions

• Drug: Alendronate

Clinical Trial Outcome Measures

Primary Measures

• the cumulative of total hip replacement

Secondary Measures

• necrotic area
• Harris hip score

Participating 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: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborator
  • Merck Sharp & Dohme LLC
• Overall Official(s)
  • Gwo-Jaw Wang, MD, Study Chair, Kaohsiung Medical University

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. doi: 10.2106/JBJS.D.02959.