Clinical trial NCT02958020: Multicenter Cohort Study on Osteoporosis
Official title: Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Keywords: cohort, osteoporosis, bone mineral density, Chinese
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: Dongzhimen Hospital, Beijing
name: The First Affiliated Hospital of Guangzhou University of TCM
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Affiliated Hospital of Changchun University of Chinese Medicine
name: Gansu Provincial Hospital
name: Guangzhou Kingmed Diagnostics Co., Ltd.
name: Shandong Provincial Hospital of Traditional Chinese Medicine
name: Yunnan Provincial Hospital of Traditional Chinese Medicine
name: Shenzhen Pingle Orthopedic Hospital
name: First People's Hospital of Nankang District, Ganzhou City
First posted: 2016-11-08
Enrollment: 50000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: changes in bone mineral density from baseline to 2, 4, 6, 8 and 10 years after enrollment
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary outcomes:
measure: fracture questionnaire
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum osteocalcin
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum procollagen type I N-terminal propeptide (PINP)
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum bone alkaline phosphatase (BALP)
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum β-crosslaps (β-CTX)
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum Ca
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum P
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum Mg
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum fibroblast growth factor (FGF)23
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum parathormone (PTH)
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
measure: serum total 25(OH) vitamin D
timeFrame: at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Pingle Orthopedic Hospital
state: Guangdong
city: Ganzhou
country: China
facility: First People's Hospital of Nankang District, Ganzhou City
state: Jiangxi
city: Jinan
country: China
facility: Shandong Provincial Hospital of Traditional Chinese Medicine
state: Shandong
city: Kunming
country: China
facility: Yunnan Provincial Hospital of Traditional Chinese Medicine
state: Yunnan
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing
city: Beijing
country: China
facility: Wangjing Hospital, China Academy of Chinese Medical Sciences
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of Traditional Chinese Medicine
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
city: Guangzhou
country: China
facility: Guangzhou Kingmed Diagnostics Co., Ltd.
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
Study officials:
affiliation: Shanhgai University of TCM
name: Yongjun Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.