Femur Head NecrosisNCT00244400
Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis
An observational study of Femur Head Necrosis, run by Osaka City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Femur Head Necrosis
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2002to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of avascular necrosis of the femur
Who cannot join
- Old age (> 70 years)
- Severe hepatic or renal dysfunction
- Heart disease
- Current use of known CYP3A-inducing or -inhibiting drugs
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Medicine, Osaka City University
Osaka, Osaka, 545-8585
About this study
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.
Read the 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.
- Conditions
- Femur Head Necrosis
- Keywords
- Femur Head Necrosis, CYP3A
- Medical subject headings
- Femur Head Necrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startNov 2002
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Head NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Osaka City University
- Sponsor type
- University, hospital or other
- Investigators
- Yasunori Kaneshiro, M.D., Principal investigator, Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244400
- Sponsor's protocol ID
- 338
- Status last verified
- Oct 2006
- First submitted
- 25 Oct 2005
- Last updated
- 17 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis
- ClinicalTrials.gov ID
- NCT00244400
- Acronym / sponsor ID
- 338
- Conditions
- Femur Head Necrosis
- Keywords
- Femur Head Necrosis, CYP3A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Osaka City UniversityUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Jan 2006
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of avascular necrosis of the femur
Key exclusion criteria (5 listed)
- Old age (> 70 years)
- Severe hepatic or renal dysfunction
- Heart disease
- Current use of known CYP3A-inducing or -inhibiting drugs
- Morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasunori Kaneshiro, M.D. principal investigator
Department of Orthopedic Surgery, Graduate School of Medicine, Osaka City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Head Necrosis, run by Osaka City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2006.