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

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ClinicalTrials.gov Identifier: NCT00244400
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : October 17, 2006
Sponsor:
Information provided by:
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.

Condition or disease
Femur Head Necrosis

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 Type : Observational
Enrollment : 200 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Study Start Date : November 2002
Study Completion Date : January 2006




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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00244400     History of Changes
Other Study ID Numbers: 338
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: October 2006

Keywords provided by Osaka City University:
Femur Head Necrosis
CYP3A

Additional relevant MeSH terms:
Necrosis
Femur Head Necrosis
Pathologic Processes
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases