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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Femur Head Necrosis

Keywords

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Femur Head Necrosis CYP3A

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Yasunori Kaneshiro, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Graduate School of Medicine, Osaka City University

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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338

Identifier Type: -

Identifier Source: org_study_id