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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02365077

Enrollment

2500

Registered

2015-02-18

Start date

2015-01-01

Completion date

2023-12-31

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Glucocorticoids and Synthetic Analogues, Femur Head Necrosis

Keywords

Adverse Effect of Glucocorticoids, Femur Head Necrosis, Susceptibility, GWAS

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Glucocorticoid-induced femur head necrosis	1 year	Hip joint MRI for the patients with a history of taking 1800 mg prednisolone or an equivalent over 4 week.

Countries

China

Outcome results