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

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 Overview

• Status: Enrolling by invitation
• Conditions: Femur Head Necrosis; Adverse Effect of Glucocorticoids and Synthetic Analogues

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospitial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients coming from the Department of Dermatology Xijing Hospital, Fourth Military Medical University Xi'an, China

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: GWAS; Femur Head Necrosis; Susceptibility; Adverse Effect of Glucocorticoids
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis; Necrosis; Disease Susceptibility; Femur Head Necrosis
• Other Study ID Numbers: CUP2015D001