Multicenter Cohort Study on Osteoporosis
1 other identifier
observational
50,000
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
September 23, 2021
September 1, 2021
9.9 years
November 3, 2016
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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
- +6 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- permanent residents
- women aged from 45 to 79, and men aged from 50 to 79
You may not qualify if:
- severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
- lactating or pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai University of Traditional Chinese Medicinelead
- Wangjing Hospital, China Academy of Chinese Medical Sciencescollaborator
- Dongzhimen Hospital, Beijingcollaborator
- The First Affiliated Hospital of Guangzhou University of TCMcollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
- Affiliated Hospital of Changchun University of Chinese Medicinecollaborator
- Gansu Provincial Hospitalcollaborator
- Guangzhou Kingmed Diagnostics Co., Ltd.collaborator
- Affiliated Hospital of Shandong University of Traditional Chinese Medicinecollaborator
- Yunnan Provincial Hospital of Traditional Chinese Medicinecollaborator
- Shenzhen Pingle Orthopedic Hospitalcollaborator
- First People's Hospital of Nankang District, Ganzhou Citycollaborator
Study Sites (12)
Shenzhen Pingle Orthopedic Hospital
Shenzhen, Guangdong, China
First People's Hospital of Nankang District, Ganzhou City
Ganzhou, Jiangxi, China
Shandong Provincial Hospital of Traditional Chinese Medicine
Jinan, Shandong, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
Dongzhimen Hospital, Beijing
Beijing, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
Guangzhou Kingmed Diagnostics Co., Ltd.
Guangzhou, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, China
Longhua Hospital, Shanghai University of TCM
Shanghai, China
Related Publications (2)
Wang J, Shu B, Li CG, Xie XW, Liang D, Chen BL, Lin XC, Wei X, Wang L, Leng XY, Zhou YJ, Chen PZ, Tao YR, Zhou Y, Zhang Y, Cui XJ, Lu S, Wang H, Shi Q, Wang YJ. Polymorphisms of genes related to vitamin D metabolism and transportation and its relationship with the risk of osteoporosis: protocol for a multicentre prospective cohort study in China. BMJ Open. 2019 Nov 24;9(11):e028084. doi: 10.1136/bmjopen-2018-028084.
PMID: 31767578DERIVEDWang J, Chen L, Zhang Y, Li CG, Zhang H, Wang Q, Qi X, Qiao L, Da WW, Cui XJ, Lu S, Wang YJ, Shu B. Association between serum vitamin B6 concentration and risk of osteoporosis in the middle-aged and older people in China: a cross-sectional study. BMJ Open. 2019 Jul 4;9(7):e028129. doi: 10.1136/bmjopen-2018-028129.
PMID: 31278103DERIVED
Biospecimen
DNA from blood cells will be preserved for specific study including SNP ananlyses.Tongue coating and feces will be preserved for microflora analyses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongjun Wang
Shanhgai University of TCM
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 8, 2016
Study Start
November 1, 2016
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
September 23, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share