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临床试验/NCT02958020
NCT02958020招募中不适用

Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China

Shanghai University of Traditional Chinese Medicine12 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50,000
试验地点
12
主要终点
changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment

研究概览

简要总结

This is a multicenter cohort study on osteoporosis in nine cities of China which locate in the east, south, north, west, middle of China. At least 3000 middle-aged and elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city will be enrolled. Residents with severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey as well as lactating or pregnant women were excluded. All the enrolled residents who signed informed consent will finish questionnaire including demographic characteristics, history of smoking, alcohol drinking, falls and fracture, family genetic history, chronic diseases and medicine,diary and physical practice,stool and urine status. Osteoporosis risk, health status, constitution of traditional Chinese medicine (TCM),symptoms of kidney yang deficiency in TCM,living environment,sweating status will be evaluated. Fasting blood glucose test and other blood tests for liver and kidney function,bone metabolism,vitamins,vitamin D metabolism and transportation as well as calcium and phosphate metabolism, will be performed. Bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will also be performed at enrollment and every two years after enrollment. DNA of blood cells will be preserved for specific study such as SNP analyses.Tongue coating and feces will be preserved for microflora analyses.

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
45 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • permanent residents
  • women aged from 45 to 79, and men aged from 50 to 79

排除标准

  • severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
  • lactating or pregnant women.

结局指标

主要结局

changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment

时间窗: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

lumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry.

次要结局

  • serum β-crosslaps (β-CTX)(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • fracture questionnaire(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum bone alkaline phosphatase (BALP)(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum Ca(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum P(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum fibroblast growth factor (FGF)23(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum total 25(OH) vitamin D(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum Mg(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum osteocalcin(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum procollagen type I N-terminal propeptide (PINP)(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)
  • serum parathormone (PTH)(at enrollment, and 2, 4, 6, 8 and 10 years after enrollment)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bing Shu

Associate Professor

Shanghai University of Traditional Chinese Medicine

研究点 (12)

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