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

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ClinicalTrials.gov Identifier: NCT02365077
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
xjpfW, Xijing Hospital

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.

Condition or disease
Femur Head Necrosis Adverse Effect of Glucocorticoids and Synthetic Analogues

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.



Primary Outcome Measures :
  1. Glucocorticoid-induced femur head necrosis [ Time Frame: 1 year ]
    Hip joint MRI for the patients with a history of taking 1800 mg prednisolone or an equivalent over 4 week.


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.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients coming from the Department of Dermatology Xijing Hospital, Fourth Military Medical University Xi'an, China
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365077


Contacts
Contact: Gang Gang, MD,PhD 86-29-84775401 xjpfwanggang@163.com
Contact: Chen Yu

Locations
China, Shaanxi
Xijing Hospitial Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Aidong Wen, MD    86-29-84771162      
Principal Investigator: Gang Wang, M.D.         
Sub-Investigator: Chen Yu, M.M.         
Sponsors and Collaborators
Xijing Hospital

Responsible Party: xjpfW, Chief in Department of Dermatology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02365077     History of Changes
Other Study ID Numbers: CUP2015D001
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Keywords provided by xjpfW, Xijing Hospital:
Adverse Effect of Glucocorticoids
Femur Head Necrosis
Susceptibility
GWAS

Additional relevant MeSH terms:
Osteonecrosis
Necrosis
Disease Susceptibility
Femur Head Necrosis
Pathologic Processes
Disease Attributes
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs