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

Condition(s) targeted: Non-Traumatic Osteonecrosis

Intervention: Alendronate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Official(s) and/or principal investigator(s):
Gwo-Jaw Wang, MD, Study Chair, Affiliation: Kaohsiung Medical University

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: the cumulative of total hip replacement

Secondary outcome:

necrotic area

Harris hip score

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

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung 807, Taiwan

Related publications:

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.

Starting date: June 2005
Last updated: February 26, 2008