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

This study has been completed.
Sponsor:
Information provided by:
Osaka City University
ClinicalTrials.gov Identifier:
NCT00244400
First received: October 25, 2005
Last updated: October 16, 2006
Last verified: October 2006
History of Changes
  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 May 19, 2013