drugset / Trial / NCT00265252
Alendronate in the Prevention of Collapse of Femoral Head in Non-Traumatic Osteonecrosis
Phase 4
Unknown
60 enrolled
Kaohsiung Medical University Chung-Ho Memorial Hospital
Merck Sharp & Dohme LLC · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
To determine the cumulative incidence of total hip replacement, time to event after treatment with Fosamax or placebo during the study peroid
Timeline
- Start
- 2005-06
- Primary completion
- —
- Completion
- 2008-06
Outcome
Missed primary endpoint
paper Four of 32 hips in the alendronate treatment group underwent THA, while 5 of 33 hips in the placebo group had THA (P = 0.837). PMID 22127729 ↗
paper Alendronate has no obvious effect on preventing the necessity for THA PMID 22127729 ↗
Publications
- Background 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.
- Chen CH, Chang JK, Lai KA, Hou SM, Chang CH, Wang GJ. Alendronate in the prevention of collapse of the femoral head in nontraumatic osteonecrosis: a two-year multicenter, prospective, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 May;64(5):1572-8. doi: 10.1002/art.33498.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | — | — |