Family Cohort Study on Primary Osteoporosis

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.

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

Conditions
-----------------
Family Genetic Characteristics of Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in bone mineral density from baseline to 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 | at enrollment | 
| changes in bone mineral density from baseline to 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 | 5 years after enrollment | 
| Physical phenotype of traditional Chinese medicine | Occurrence of kidney yang deficiency | at enrollment | 
| Physical phenotype of traditional Chinese medicine | Occurrence of kidney yang deficiency | 5 years after enrollment | 
| Understand the general situation through the questionnaire | 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 | at enrollment | 
| Understand the general situation through the questionnaire | 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 | 5 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteocalcin | serum osteocalcin | at enrollment | 
| procollagen type I N-terminal propeptide | serum procollagen type I N-terminal propeptide (PINP) | at enrollment | 
| Bone alkaline phosphatase | serum bone alkaline phosphatase (BALP) | at enrollment | 
| β-crosslaps | serum β-crosslaps (β-CTX) | at enrollment | 
| Ca | serum Ca | at enrollment | 
| P | serum P | at enrollment | 
| Mg | serum Mg | at enrollment | 
| Fibroblast growth factor | serum fibroblast growth factor (FGF)23 | at enrollment | 
| Parathormone | serum parathormone (PTH) | at enrollment | 
| 25(OH) vitamin D | serum total 25(OH) vitamin D | at enrollment | 
| Osteocalcin | serum osteocalcin | 5 years after enrollment | 
| Procollagen type I N-terminal propeptide | serum procollagen type I N-terminal propeptide (PINP) | 5 years after enrollment | 
| Bone alkaline phosphatase | serum bone alkaline phosphatase (BALP) | 5 years after enrollment | 
| β-crosslaps | serum β-crosslaps (β-CTX) | 5 years after enrollment | 
| Ca | serum Ca | 5 years after enrollment | 
| P | serum P | 5 years after enrollment | 
| Mg | serum Mg | 5 years after enrollment | 
| Fibroblast growth factor | serum fibroblast growth factor (FGF)23 | 5 years after enrollment | 
| Parathormone | serum parathormone (PTH) | 5 years after enrollment | 
| 25(OH) vitamin D | serum total 25(OH) vitamin D | 5 years after enrollment | 
| Gene testing(BGIseq T5,WGS) | Carry out whole-gene testing on the samples with obvious family heritability of osteoporosis, and analyze the differences at the gene level through sequencing compared with the control group | at enrollment | 
| Gene testing(BGIseq T5,WGS) | Carry out whole-gene testing on the samples with obvious family heritability of osteoporosis, and analyze the differences at the gene level through sequencing compared with the control group | 5 years after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis families, Kidney-yang deficiency, Genetic correlation of disease, Bone density