ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 1252 for:    "Osteoporosis"

Multicenter Cohort Study on Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02958020
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
Wangjing Hospital, China Academy of Chinese Medical Sciences
Dongzhimen Hospital, Beijing
The 309th Hospital of Chinese People's Libertation Army
The First Affiliated Hospital, Guangzhou University of TCM
Guangdong Provincial Hospital of Traditional Chinese Medicine
Affiliated Hospital of Changchun University of Chinese Medicine
Gansu Provincial Hospital
Luoyang Zhenggu Hospital
Guangzhou Kingmed Diagnostics Co., Ltd.
Information provided by (Responsible Party):
Bing Shu, Shanghai University of Traditional Chinese Medicine

Brief Summary:
This is a multicenter cohort study on osteoporosis in six cities of China which locate in the east, south, north, west, middle of China respectively. 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 were 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, chronic diseases and medicine,diary and physical practice. Osteoporosis risk, health status (EQ-5D) and constitution of traditional Chinese medicine (TCM) will be evaluated. Fasting blood tests, bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will be performed at enrollment and every two years after enrollment. DNA of blood cells will be preserved.

Condition or disease
Osteoporosis

Study Type : Observational
Estimated Enrollment : 18000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Cohort Study on Osteoporosis in the Middle-aged and Elderly People in Shanghai, China
Study Start Date : November 2016
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2028

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
DNA from blood cells will be preserved for specific study.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Six cities which locate in the east, south, north, west, middle of China respectively were involved. In each city, 3000 middle-aged and elderly permanent residents were enrolled.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958020


Contacts
Contact: Yongjun Wang 86-21-64385700 ext 9903 yjwang88@hotmail.com

Locations
China
Dongzhimen Hospital, Beijing Recruiting
Beijing, China
Contact: Xinchao Lin         
The 309th Hospital of Chinese People's Libertation Army Recruiting
Beijing, China
Contact: Liang Wang         
Wangjing Hospital, China Academy of Chinese Medical Sciences Recruiting
Beijing, China
Contact: Yanming Xie         
Affiliated Hospital of Changchun University of Traditional Chinese Medicine Recruiting
Changchun, China
Contact: Xiangyang Leng         
Guangdong Provincial Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, China
Contact: Bolai Chen         
Guangzhou Kingmed Diagnostics Co., Ltd. Recruiting
Guangzhou, China
Contact: Jiangtao Xie         
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Recruiting
Guangzhou, China
Contact: De Liang         
Gansu Provincial Hospital of Traditional Chinese Medicine Recruiting
Lanzhou, China
Contact: Xingwen Xie         
Luoyang Zhenggu Hospital Not yet recruiting
Luoyang, China
Contact: Yingjie Zhou         
Longhua Hospital, Shanghai University of TCM Recruiting
Shanghai, China
Contact: Yongjun Wang         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Wangjing Hospital, China Academy of Chinese Medical Sciences
Dongzhimen Hospital, Beijing
The 309th Hospital of Chinese People's Libertation Army
The First Affiliated Hospital, Guangzhou University of TCM
Guangdong Provincial Hospital of Traditional Chinese Medicine
Affiliated Hospital of Changchun University of Chinese Medicine
Gansu Provincial Hospital
Luoyang Zhenggu Hospital
Guangzhou Kingmed Diagnostics Co., Ltd.
Investigators
Principal Investigator: Yongjun Wang Shanhgai University of TCM

Responsible Party: Bing Shu, Associate Professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02958020     History of Changes
Other Study ID Numbers: osteoporosis cohort
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bing Shu, Shanghai University of Traditional Chinese Medicine:
cohort, osteoporosis, bone mineral density, Chinese

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases