GWAS Identified Susceptibility Loci for Glucocorticoid-induced FHN in the Chinese Population

NCT ID: NCT02365077

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2023-12-31

Brief 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). Our purpose is to find susceptibility loci for glucocorticoid-induced femur head necrosis in the Chinese population.

Conditions

Femur Head Necrosis; Adverse Effect of Glucocorticoids and Synthetic Analogues

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Subject has given the written informed consent voluntarily;

2. Male or female between 18~60 years;

3. 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);

4. 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.

Exclusion Criteria

1. Subject is not in conformity with diagnostic criteria for ONFH;

2. Patient has a history of trauma in the lower limbs or pelvis;

3. Prolonged addiction to alcohol;

4. Concurrent with renal failure, organ transplant, graft versus host disease, inflammatory bowel disease, HIV infection or leukemia;

5. Patient with familial idiopathic ONFH;

6. Subject suffers from a fatal disease, with life expectancy < 2 months;

7. Woman of child-bearing potential, who is pregnant, in preparation of pregnancy or breast-feeding during the study period;

8. Other patients deemed ineligible at the discretion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Chief in Department of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xijing Hospitial

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

CUP2015D001

Identifier Type: -

Identifier Source: org_study_id