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Multicenter Cohort Study on Osteoporosis

Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02958020
Enrollment
50000
Registered
2016-11-08
Start date
2016-11-30
Completion date
2028-10-31
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

cohort, osteoporosis, bone mineral density, Chinese

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.

Interventions

None listed

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
CollaboratorOTHER
Dongzhimen Hospital, Beijing
CollaboratorOTHER
The First Affiliated Hospital of Guangzhou University of TCM
CollaboratorUNKNOWN
Guangdong Provincial Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Affiliated Hospital of Changchun University of Chinese Medicine
CollaboratorOTHER
Gansu Provincial Hospital
CollaboratorOTHER
Guangzhou Kingmed Diagnostics Co., Ltd.
CollaboratorUNKNOWN
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
CollaboratorOTHER
Yunnan Provincial Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
Shenzhen Pingle Orthopedic Hospital
CollaboratorUNKNOWN
First People's Hospital of Nankang District, Ganzhou City
CollaboratorUNKNOWN
Shanghai University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollmentat enrollment, and 2, 4, 6, 8 and 10 years after enrollmentlumbar (L1-4 as well as total) and hip bone mineral density will be recorded by dual energy X-ray absorptiometry.

Secondary

MeasureTime frameDescription
serum Pat enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum Mgat enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum fibroblast growth factor (FGF)23at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
fracture questionnaireat enrollment, and 2, 4, 6, 8 and 10 years after enrollmentinformation about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire
serum osteocalcinat enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum Caat 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
serum parathormone (PTH)at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum total 25(OH) vitamin Dat 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

Countries

China

Contacts

Primary ContactYongjun Wang
yjwang88@hotmail.com86-21-64385700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026