Multicenter Cohort Study on Osteoporosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoporosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: permanent residents women aged from 45 to 79, and men aged from 50 to 79 Exclusion Criteria: severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey. lactating or pregnant women.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in bone mineral density from baseline to 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. | at enrollment, and 2, 4, 6, 8 and 10 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture questionnaire | information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire | 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 bone alkaline phosphatase (BALP) |  | at enrollment, and 2, 4, 6, 8 and 10 years after enrollment | 
| serum β-crosslaps (β-CTX) |  | 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 Mg |  | 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 parathormone (PTH) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cohort, osteoporosis, bone mineral density, Chinese