Ireland
--:--IST
Recruiting Observational

Multicenter Cohort Study on Osteoporosis

NCT02958020 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2016-11
Last updated
2021-09-23

Condition(s) studied

Osteoporosis

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
79 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (12)

FacilityCityRegionStatus
Shenzhen Pingle Orthopedic Hospital Shenzhen Guangdong Recruiting
First People's Hospital of Nankang District, Ganzhou City Ganzhou Jiangxi Recruiting
Shandong Provincial Hospital of Traditional Chinese Medicine Jinan Shandong Recruiting
Yunnan Provincial Hospital of Traditional Chinese Medicine Kunming Yunnan Not Yet Recruiting
Dongzhimen Hospital, Beijing Beijing China Recruiting
Wangjing Hospital, China Academy of Chinese Medical Sciences Beijing China Recruiting
Affiliated Hospital of Changchun University of Traditional Chinese Medicine Changchun China Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou China Recruiting
Guangzhou Kingmed Diagnostics Co., Ltd. Guangzhou China Recruiting
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Guangzhou China Recruiting
Gansu Provincial Hospital of Traditional Chinese Medicine Lanzhou China Recruiting
Longhua Hospital, Shanghai University of TCM Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02958020 on ClinicalTrials.gov ↗ ← All trials in China