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临床试验/NCT03456271
NCT03456271终止不适用

A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community

Zhujiang Hospital5 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
99
试验地点
5
主要终点
fracture

研究概览

简要总结

The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.

排除标准

  • type 1 diabetes and other specific types of diabetes;
  • diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status.
  • had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones);
  • suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction);
  • disuse osteoporosis;
  • cannot be exposure to sunlight due to skin diseases;
  • use glucocorticoids for over 3 months.

结局指标

主要结局

fracture

时间窗: 3 years

the participants happen to fracture

次要结局

未报告次要终点

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Sponsor

研究点 (5)

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