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NCT Number: NCT02958020

Multicenter Cohort Study on Osteoporosis

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.

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Pingle Orthopedic Hospital, Shenzhen, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. serum osteocalcin

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

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

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

  4. serum bone alkaline phosphatase (BALP)

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

  5. serum β-crosslaps (β-CTX)

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

  6. serum Ca

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

  7. serum P

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

  8. serum Mg

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

  9. serum fibroblast growth factor (FGF)23

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

  10. serum parathormone (PTH)

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

  11. serum total 25(OH) vitamin D

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yongjun Wang

CONTACT

[email protected]

86-21-64385700 ext. 9903

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Nov 8, 2016
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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