NCT02365077Unknown不适用
Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Glucocorticoid-induced femur head necrosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Glucocorticoid-induced femur head necrosis
时间窗: 1 year
Hip joint MRI for the patients with a history of taking 1800 mg prednisolone or an equivalent over 4 week.
次要结局
未报告次要终点
研究者
xjpfW
Chief in Department of Dermatology
Xijing Hospital
研究点 (1)
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