Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis

Completed

• Conditions: Femur Head Necrosis

• Registration Number: NCT00244400
• Lead Sponsor: Osaka City University

Brief Summary

The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Detailed Description

Femur head necrosis is one of the major side effects of corticosteroid therapy. Since corticosteroids are metabolized by hepatic cytochrome P-450 (CYP) 3A, a low endogenous activity of this enzyme may contribute to the pathogenesis of ONFH. The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Study Completion: 2006-01
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-16
• Last Update Posted: 2006-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Clinical diagnosis of avascular necrosis of the femur

Exclusion Criteria

• Old age (> 70 years)
• Severe hepatic or renal dysfunction
• Heart disease
• Current use of known CYP3A-inducing or -inhibiting drugs
• Morbid obesity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Graduate School of Medicine, Osaka City University; 🇯🇵 Osaka, Japan