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NCT00244400 Clinical Trial

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

Femur Head Necrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00244400
Other study ID # 338
Secondary ID
Status Completed
Phase N/A
First received October 25, 2005
Last updated October 16, 2006
Start date November 2002
Est. completion date January 2006

Study information
Verified date October 2006
Source Osaka City University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 70 Years
Eligibility 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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Graduate School of Medicine, Osaka City University Osaka

Sponsors (1)
Lead Sponsor Collaborator
Osaka City University

Country where clinical trial is conducted

Japan, 

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