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Recruiting NCT02958020

Multicenter Cohort Study on Osteoporosis

— Observational Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteoporosis. Basic parameters: 45 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (11)
  • fracture questionnaire [Time frame: 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]
  • serum procollagen type I N-terminal propeptide (PINP) [Time frame: 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]
  • serum β-crosslaps (β-CTX) [Time frame: 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]
  • serum P [Time frame: 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]
  • serum fibroblast growth factor (FGF)23 [Time frame: 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]
  • serum total 25(OH) vitamin D [Time frame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 12 centers
  • Shenzhen Pingle Orthopedic Hospital — Shenzhen
  • First People's Hospital of Nankang District, Ganzhou City — Ganzhou
  • Shandong Provincial Hospital of Traditional Chinese Medicine — Jinan
  • Yunnan Provincial Hospital of Traditional Chinese Medicine — Kunming
  • Dongzhimen Hospital, Beijing — Beijing
  • Wangjing Hospital, China Academy of Chinese Medical Sciences — Beijing
  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine — Changchun
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
  • … and 4 more centers

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/b PMID 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. PMID 31278103

Identifiers

NCT: NCT02958020 · osteoporosis cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗