Examine the Possible Association of Hepatic CYP3A Activit... | NCT00244400

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

NCT00244400

Sponsor

Osaka City University

Status

Completed

Last Update Posted

Oct 17, 2006Estimated

Enrollment

200

Phase

Not provided

Conditions

Femur Head Necrosis

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Oct 25, 2005

First Submission Date that Met QC Criteria

Oct 25, 2005

First Posted Date

Oct 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2006

Last Update Posted Date

Oct 17, 2006Estimated

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasunori Kaneshiro, M.D.	Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate School of Medicine, Osaka City University		Osaka	Osaka	545-8585	Japan

Condition Browse Module

MeSH Terms

ID	Term
D005271	Femur Head Necrosis

Ancestor Terms

ID	Term
D010020	Osteonecrosis
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009336	Necrosis

Browse Leaves

Not provided

Browse Branches

Not provided