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

Study Overview
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Brief Summary
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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.

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

Conditions
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Femur Head Necrosis, Adverse Effect of Glucocorticoids and Synthetic Analogues

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse Effect of Glucocorticoids, Femur Head Necrosis, Susceptibility, GWAS