跳至主要内容
临床试验/NCT05781594
NCT05781594招募中不适用

Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome

Shanghai University of Traditional Chinese Medicine3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
3
主要终点
changes in bone mineral density from baseline to 5 years after enrollment

研究概览

简要总结

Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency

详细描述

Families with or without osteoporosis of kidney-yang deficiency type will be included and compared with each other. Their genetic characteristics, bone changes, and TCM constitution are the focus of research.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.

排除标准

  • Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.

结局指标

主要结局

changes in bone mineral density from baseline to 5 years after enrollment

时间窗: 5 years after enrollment

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

Physical phenotype of traditional Chinese medicine

时间窗: 5 years after enrollment

Occurrence of kidney yang deficiency

Understand the general situation through the questionnaire

时间窗: 5 years after enrollment

Including age(year), sex(man,wowan), height(cm), weight(kg), menstrual period,history of smoking and drinking, living habits, fracture history and risk assessment, skeletal muscle assessment, living environment, Chinese medicine constitution, etc

次要结局

  • Ca(5 years after enrollment)
  • Osteocalcin(5 years after enrollment)
  • procollagen type I N-terminal propeptide(at enrollment)
  • Procollagen type I N-terminal propeptide(5 years after enrollment)
  • Mg(5 years after enrollment)
  • Parathormone(5 years after enrollment)
  • Bone alkaline phosphatase(5 years after enrollment)
  • β-crosslaps(5 years after enrollment)
  • P(5 years after enrollment)
  • Fibroblast growth factor(5 years after enrollment)
  • 25(OH) vitamin D(5 years after enrollment)
  • Gene testing(BGIseq T5,WGS)(5 years after enrollment)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (3)

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