Clinical Trial

Multicenter Cohort Study on Osteoporosis

Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2016-11-04; most recent amendment 2021-09-21.
Status change: Not Yet Recruiting → Recruiting 2018-04-16
Trial Details
NCT Number NCT02958020
Lead Sponsor Shanghai University of Traditional Chinese Medicine
Collaborators: Wangjing Hospital, China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, The First Affiliated Hospital of Guangzhou University of TCM, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Chinese Medicine, Gansu Provincial Hospital, Guangzhou Kingmed Diagnostics Co., Ltd., Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Yunnan Provincial Hospital of Traditional Chinese Medicine, Shenzhen Pingle Orthopedic Hospital, First People's Hospital of Nankang District, Ganzhou City
Conditions Osteoporosis
Enrollment 50,000 participants
Start Date 2016-11
Primary Completion 2026-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2021-09-23