Multicenter Cohort Study on Osteoporosis
- Conditions
- Osteoporosis
- Registration Number
- NCT02958020
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
- permanent residents
- women aged from 45 to 79, and men aged from 50 to 79
- severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
- lactating or pregnant women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment 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.
- Secondary Outcome Measures
Name Time Method 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 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 information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire
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
Trial Locations
- Locations (12)
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, China
Gansu Provincial Hospital of Traditional Chinese Medicine
🇨🇳Lanzhou, China
Dongzhimen Hospital, Beijing
🇨🇳Beijing, China
Shenzhen Pingle Orthopedic Hospital
🇨🇳Shenzhen, Guangdong, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
🇨🇳Guangzhou, China
First People's Hospital of Nankang District, Ganzhou City
🇨🇳Ganzhou, Jiangxi, China
Shandong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Jinan, Shandong, China
Longhua Hospital, Shanghai University of TCM
🇨🇳Shanghai, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, China
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
🇨🇳Changchun, China
Guangzhou Kingmed Diagnostics Co., Ltd.
🇨🇳Guangzhou, China