Family Cohort Study on Primary Osteoporosis With Kidney-yang Deficiency Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 3
- Primary Endpoint
- changes in bone mineral density from baseline to 5 years after enrollment
Study Overview
Brief Summary
Bone metabolism and genetic characteristics of osteoporosis pedigree with kidney-yang deficiency
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be able to cooperate with inspection.There is blood relationship between the members of the enrolled family.
Exclusion Criteria
- •Unable to cooperate with inspection.There is not blood relationship between the members of the enrolled family.
Outcomes
Primary Outcomes
changes in bone mineral density from baseline to 5 years after enrollment
Time Frame: 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
Time Frame: 5 years after enrollment
Occurrence of kidney yang deficiency
Understand the general situation through the questionnaire
Time Frame: 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
Secondary Outcomes
- Bone alkaline phosphatase(5 years after enrollment)
- β-crosslaps(5 years after enrollment)
- P(5 years after enrollment)
- Gene testing(BGIseq T5,WGS)(5 years after enrollment)
- Osteocalcin(5 years after enrollment)
- procollagen type I N-terminal propeptide(at enrollment)
- Ca(5 years after enrollment)
- Procollagen type I N-terminal propeptide(5 years after enrollment)
- Mg(5 years after enrollment)
- Parathormone(5 years after enrollment)
- Fibroblast growth factor(5 years after enrollment)
- 25(OH) vitamin D(5 years after enrollment)