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

This study has been completed.

First Received on October 25, 2005. Last Updated on October 16, 2006 History of Changes

Sponsor:	Osaka City University
Information provided by:	Osaka City University
ClinicalTrials.gov Identifier:	NCT00244400

Purpose

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.

Condition
Femur Head Necrosis

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Retrospective

Further study details as provided by Osaka City University:

Estimated Enrollment:	200
Study Start Date:	November 2002
Estimated Study Completion Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	14 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244400

Locations

Japan
Graduate School of Medicine, Osaka City University
Osaka, Japan, 545-8585

Sponsors and Collaborators

Osaka City University

Investigators

Principal Investigator:

Yasunori Kaneshiro, M.D.

Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00244400 History of Changes
Other Study ID Numbers:	338
Study First Received:	October 25, 2005
Last Updated:	October 16, 2006
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka City University:

Femur Head Necrosis
CYP3A

Additional relevant MeSH terms:

Femur Head Necrosis
Necrosis
Osteonecrosis

Bone Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012