Multicenter Cohort Study on Osteoporosis

September 21, 2021 updated by: Bing Shu, Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Dongzhimen Hospital, Beijing
        • Contact:
          • Xinchao Lin
      • Beijing, China
        • Recruiting
        • Wangjing Hospital, China Academy of Chinese Medical Sciences
        • Contact:
          • Yanming Xie
      • Changchun, China
        • Recruiting
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine
        • Contact:
          • Xiangyang Leng
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Bolai Chen
      • Guangzhou, China
        • Recruiting
        • Guangzhou Kingmed Diagnostics Co., Ltd.
        • Contact:
          • Jiangtao Xie
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
        • Contact:
          • De Liang
      • Lanzhou, China
        • Recruiting
        • Gansu Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Xingwen Xie
      • Shanghai, China
        • Recruiting
        • Longhua Hospital, Shanghai university of TCM
        • Contact:
          • Yongjun Wang
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Pingle Orthopedic Hospital
        • Contact:
          • Baolin Li
          • Phone Number: 13923865111
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Recruiting
        • First People's Hospital of Nankang District, Ganzhou City
        • Contact:
          • Yuping Zeng
          • Phone Number: 13970701683
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Wei Shi
          • Phone Number: 15153165961
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Yunnan Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Lijuan Jiang
          • Phone Number: 13668781266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment
Time Frame: at enrollment, and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
fracture questionnaire
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum osteocalcin
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum procollagen type I N-terminal propeptide (PINP)
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum bone alkaline phosphatase (BALP)
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum β-crosslaps (β-CTX)
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum Ca
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum P
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum Mg
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum fibroblast growth factor (FGF)23
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum parathormone (PTH)
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
serum total 25(OH) vitamin D
Time Frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

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

Investigators

  • Principal Investigator: Yongjun Wang, Shanhgai University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

October 1, 2028

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • osteoporosis cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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