Multicenter Cohort Study on Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958020
• Other study ID #: osteoporosis cohort
• Status: Recruiting
• Start date: November 2016
• Est. completion date: October 2028

Study information

• Verified date: September 2021
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yongjun Wang
• Phone: 86-21-64385700
• Email: yjwang88[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: October 2028
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Locations

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

Sponsors (12)

Lead Sponsor

Collaborator

Shanghai University of Traditional Chinese Medicine

Affiliated Hospital of Changchun University of 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., Shandong Provincial Hospital of Traditional Chinese Medicine, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	fracture questionnaire	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
Secondary	serum osteocalcin		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum procollagen type I N-terminal propeptide (PINP)		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum bone alkaline phosphatase (BALP)		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum ß-crosslaps (ß-CTX)		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum Ca		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum P		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum Mg		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum fibroblast growth factor (FGF)23		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum parathormone (PTH)		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment
Secondary	serum total 25(OH) vitamin D		at enrollment, and 2, 4, 6, 8 and 10 years after enrollment