NCT00244400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

October 17, 2006

Status Verified

October 1, 2006

First QC Date

October 25, 2005

Last Update Submit

October 16, 2006

Conditions

Femur Head Necrosis

Keywords

Femur Head NecrosisCYP3A

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of avascular necrosis of the femur

You may not qualify if:

  • Old age (\> 70 years)
  • Severe hepatic or renal dysfunction
  • Heart disease
  • Current use of known CYP3A-inducing or -inhibiting drugs
  • Morbid obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Medicine, Osaka City University

Osaka, Osaka, 545-8585, Japan

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yasunori Kaneshiro, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

November 1, 2002

Study Completion

January 1, 2006

Last Updated

October 17, 2006

Record last verified: 2006-10

Locations

JP(1)