Multicenter Cohort Study on Osteoporosis

NCT ID: NCT02958020

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2028-10-31

Brief Summary

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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

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wangjing Hospital, China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou University of TCM

UNKNOWN

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Affiliated Hospital of Changchun University of Chinese Medicine

OTHER

Sponsor Role collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role collaborator

Guangzhou Kingmed Diagnostics Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Yunnan Provincial Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Shenzhen Pingle Orthopedic Hospital

UNKNOWN

Sponsor Role collaborator

First People's Hospital of Nankang District, Ganzhou City

UNKNOWN

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bing Shu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongjun Wang

Role: PRINCIPAL_INVESTIGATOR

Shanhgai University of TCM

Locations

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Shenzhen Pingle Orthopedic Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

First People's Hospital of Nankang District, Ganzhou City

Ganzhou, Jiangxi, China

Site Status RECRUITING

Shandong Provincial Hospital of Traditional Chinese Medicine

Jinan, Shandong, China

Site Status RECRUITING

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China

Site Status NOT_YET_RECRUITING

Dongzhimen Hospital, Beijing

Beijing, , China

Site Status RECRUITING

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Site Status RECRUITING

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, , China

Site Status RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, , China

Site Status RECRUITING

Guangzhou Kingmed Diagnostics Co., Ltd.

Guangzhou, , China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, , China

Site Status RECRUITING

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, , China

Site Status RECRUITING

Longhua Hospital, Shanghai University of TCM

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongjun Wang

Role: CONTACT

86-21-64385700 ext. 9903

Facility Contacts

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Baolin Li

Role: primary

13923865111

Yuping Zeng

Role: primary

13970701683

Wei Shi

Role: primary

15153165961

Lijuan Jiang

Role: primary

13668781266

Xinchao Lin

Role: primary

Yanming Xie

Role: primary

Xiangyang Leng

Role: primary

Bolai Chen

Role: primary

Jiangtao Xie

Role: primary

De Liang

Role: primary

Xingwen Xie

Role: primary

Yongjun Wang

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31767578 (View on PubMed)

Wang 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.

Reference Type DERIVED
PMID: 31278103 (View on PubMed)

Other Identifiers

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osteoporosis cohort

Identifier Type: -

Identifier Source: org_study_id

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