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OsteoporosisNCT02958020

Multicenter Cohort Study on Osteoporosis

An observational study of Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 79 years
Conditions the study is for
Osteoporosis
How many people
50,000 participants
Where
12 sitesChina
Study dates
Nov 2016to Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • permanent residents
  • women aged from 45 to 79, and men aged from 50 to 79

Who cannot join

  • severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey.
  • lactating or pregnant women.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongjun Wang contact

86-21-64385700 ext. 9903

yjwang88@hotmail.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Dongzhimen Hospital, Beijing

    Beijing

    Xinchao Lin

    Recruiting

  • Wangjing Hospital, China Academy of Chinese Medical Sciences

    Beijing

    Yanming Xie

    Recruiting

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

    Changchun

    Xiangyang Leng

    Recruiting

  • First People's Hospital of Nankang District, Ganzhou City

    Ganzhou, Jiangxi

    Yuping Zeng, 13970701683

    Recruiting

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou

    Bolai Chen

    Recruiting

  • Guangzhou Kingmed Diagnostics Co., Ltd.

    Guangzhou

    Jiangtao Xie

    Recruiting

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou

    De Liang

    Recruiting

  • Shandong Provincial Hospital of Traditional Chinese Medicine

    Jinan, Shandong

    Wei Shi, 15153165961

    Recruiting

  • Yunnan Provincial Hospital of Traditional Chinese Medicine

    Kunming, Yunnan

    Lijuan Jiang, 13668781266

    Not yet recruiting

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    Lanzhou

    Xingwen Xie

    Recruiting

  • Longhua Hospital, Shanghai University of TCM

    Shanghai

    Yongjun Wang

    Recruiting

  • Shenzhen Pingle Orthopedic Hospital

    Shenzhen, Guangdong

    Baolin Li, 13923865111

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Osteoporosis
Keywords
cohort, osteoporosis, bone mineral density, Chinese
Medical subject headings
Osteoporosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

Secondary outcomes (11)

  1. fracture questionnaire

    information about fracture including cause, time, skeletal site and therapy during the follow-up period will be collected through fracture questionnaire

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  2. serum osteocalcin

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  3. serum procollagen type I N-terminal propeptide (PINP)

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  4. serum bone alkaline phosphatase (BALP)

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  5. serum β-crosslaps (β-CTX)

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  6. serum Ca

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  7. serum P

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  8. serum Mg

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  9. serum fibroblast growth factor (FGF)23

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  10. serum parathormone (PTH)

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

  11. serum total 25(OH) vitamin D

    Measured: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02958020
Sponsor's protocol ID
osteoporosis cohort
Status last verified
Sep 2021
First submitted
3 Nov 2016
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31767578

  • 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.

    PubMed 31278103

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yongjun Wang (86-21-64385700 ext. 9903, yjwang88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02958020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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