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

NCT02365077 | Unknown DMC

• 1 other identifier: CUP2015D001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospitial

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect 4ml whole blood samples under the consent of patient and extract the genome from the samples. During the process the blood samples will be collected strickly according the international guide clinical blood specimen collection.

MeSH Terms

Conditions

Femur Head Necrosis; Disease Susceptibility

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief in Department of Dermatology

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

CN (1)