About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
permanent residents
women aged from 45 to 79, and men aged from 50 to 79
Disqualifiers
severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
lactating or pregnant women.
Trial population
Nine cities which locate in the east, south, north, west and middle of China were involved. In each city, at least 3000 middle-aged and elderly permanent residents were enrolled.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
fracture questionnaire
information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire
serum osteocalcin
serum procollagen type I N-terminal propeptide (PINP)
serum bone alkaline phosphatase (BALP)
Sponsors and contacts
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Shanghai University of Traditional Chinese Medicine
Lead sponsor
Wangjing Hospital, China Academy of Chinese Medical Sciences
Collaborator
Dongzhimen Hospital, Beijing
Collaborator
The First Affiliated Hospital of Guangzhou University of TCM
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Changchun University of Chinese Medicine
Collaborator
Gansu Provincial Hospital
Collaborator
Guangzhou Kingmed Diagnostics Co., Ltd.
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Yunnan Provincial Hospital of Traditional Chinese Medicine
Collaborator
Shenzhen Pingle Orthopedic Hospital
Collaborator
First People's Hospital of Nankang District, Ganzhou City
Collaborator