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

Femur Head Necrosis Clinical Trial

Official title:

Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02365077
• Other study ID #: CUP2015D001
• Status: Enrolling by invitation
• Start date: January 1, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effect of Glucocorticoids and Synthetic Analogues
• Disease Susceptibility
• Femur Head Necrosis
• Necrosis

Locations

Country	Name	City	State
China	Xijing Hospitial	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year