Femur Head NecrosisNCT02365077
GWAS Identified Susceptibility Loci for Glucocorticoid-induced FHN in the Chinese Population
An observational study of Femur Head Necrosis and Adverse Effect of Glucocorticoids and Synthetic Analogues, run by Xijing Hospital at 1 site in China.
Trial summary
This is a observation clinical trial. We are collecting the patients with glucocorticoid. They were divided into the experiment group (with femur head necrosis) and control group (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide association study (GWAS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femur Head Necrosis, Adverse Effect of Glucocorticoids and Synthetic Analogues
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2023
- How long will I take part?
- 1 Year
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients coming from the Department of Dermatology Xijing Hospital, Fourth Military Medical University Xi'an, China
Who may be able to join
- Subject has given the written informed consent voluntarily;
- Male or female between 18~60 years;
- Candidate is clinically diagnosed as avascular osteonecrosis of the femoral head (ONFH), in reference to the diagnostic criteria set forth by Experts' Consensus on the Diagnosis and Treatment of Osteonecrosis of the Femoral Head in Adults (edition 2012);
- Patient with history of glucocorticoid therapy, in form of oral, muscular or vascular administration, should have total dose equivalent to ≧2000 mg of Prednisone, and maintain on that dose for ≦3 months.
Who cannot join
- Subject is not in conformity with diagnostic criteria for ONFH;
- Patient has a history of trauma in the lower limbs or pelvis;
- Prolonged addiction to alcohol;
- Concurrent with renal failure, organ transplant, graft versus host disease, inflammatory bowel disease, HIV infection or leukemia;
- Patient with familial idiopathic ONFH;
- Subject suffers from a fatal disease, with life expectancy < 2 months;
- Woman of child-bearing potential, who is pregnant, in preparation of pregnancy or breast-feeding during the study period;
- Other patients deemed ineligible at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population
This is a observation clinical trial. We are collecting the patients with glucocorticoid. They were divided into the experiment group (with femur head necrosis) and control group (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide association study (GWAS). Our purpose is to find susceptibility loci for glucocorticoid-induced femur head necrosis in the Chinese population.
- Keywords
- Adverse Effect of Glucocorticoids, Femur Head Necrosis, Susceptibility, GWAS
- Medical subject headings
- Femur Head Necrosis, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | The patients of necrosis group was defined by a history of taking 1800 mg prednisolone or an equivalent over 4 week without the symptom of femur head necrosis after 1 year. | |
| Necrosis | The patients of necrosis group was defined by a history of taking 1800 mg prednisolone or an equivalent over 4 week with the diagnosis of femur head necrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucocorticoid-induced femur head necrosis
Hip joint MRI for the patients with a history of taking 1800 mg prednisolone or an equivalent over 4 week.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xjpfW, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365077
- Sponsor's protocol ID
- CUP2015D001
- Status last verified
- Mar 2021
- First submitted
- 10 Feb 2015
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population
- ClinicalTrials.gov ID
- NCT02365077
- Acronym / sponsor ID
- CUP2015D001
- Keywords
- Adverse Effect of Glucocorticoids, Femur Head Necrosis, Susceptibility, GWAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Feb 2015 (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.
This is a observation clinical trial. We are collecting the patients with glucocorticoid. They were divided into the experiment group (with femur head necrosis) and control group (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide association study (GWAS). Our purpose is to find susceptibility loci for glucocorticoid-induced femur head necrosis in the Chinese population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –The patients of necrosis group was defined by a history of taking 1800 mg prednisolone or an equivalent over 4 week without the symptom of femur head necrosis after 1 year. |
| Necrosis | – | –The patients of necrosis group was defined by a history of taking 1800 mg prednisolone or an equivalent over 4 week with the diagnosis of femur head necrosis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients coming from the Department of Dermatology Xijing Hospital, Fourth Military Medical University Xi'an, China
Key inclusion criteria (4 listed)
- Subject has given the written informed consent voluntarily;
- Male or female between 18~60 years;
- Candidate is clinically diagnosed as avascular osteonecrosis of the femoral head (ONFH), in reference to the diagnostic criteria set forth by Experts' Consensus on the Diagnosis and Treatment of Osteonecrosis of the Femoral Head in Adults (edition 2012);
- Patient with history of glucocorticoid therapy, in form of oral, muscular or vascular administration, should have total dose equivalent to ≧2000 mg of Prednisone, and maintain on that dose for ≦3 months.
Key exclusion criteria (8 listed)
- Subject is not in conformity with diagnostic criteria for ONFH;
- Patient has a history of trauma in the lower limbs or pelvis;
- Prolonged addiction to alcohol;
- Concurrent with renal failure, organ transplant, graft versus host disease, inflammatory bowel disease, HIV infection or leukemia;
- Patient with familial idiopathic ONFH;
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
Glucocorticoid-induced femur head necrosis
Time frame: 1 year
Hip joint MRI for the patients with a history of taking 1800 mg prednisolone or an equivalent over 4 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Adverse Effect of Glucocorticoids and Synthetic Analogues, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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 China. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Glucocorticoid-induced femur head necrosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 11 Mar 2021.