Overview

This trial is active, not recruiting.

Condition non-traumatic osteonecrosis
Treatment alendronate
Phase phase 4
Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator Merck Sharp & Dohme Corp.
Start date June 2005
End date June 2008
Trial size 60 participants
Trial identifier NCT00265252, fosamax 01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
the cumulative of total hip replacement
time frame:

Secondary Outcomes

Measure
necrotic area
time frame:
Harris hip score
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 85 years old.

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

Additional Information

Official title Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Kaohsiung Medical University Chung-Ho Memorial Hospital.