We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244400
First Posted: October 26, 2005
Last Update Posted: October 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Osaka City University
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00244400     History of Changes
Other Study ID Numbers: 338
First Submitted: October 25, 2005
First Posted: October 26, 2005
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