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

Non-Traumatic Osteonecrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00265252
• Other study ID #: fosamax 01
• Status: Unknown status
• Phase: Phase 4
• First received: December 12, 2005
• Last updated: February 26, 2008
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: April 2007
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-Traumatic Osteonecrosis
• Osteonecrosis

Intervention

Drug:
• Alendronate

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (4)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Merck Sharp & Dohme Corp., National Cheng-Kung University Hospital, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cumulative of total hip replacement
Secondary	necrotic area
Secondary	Harris hip score