- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451397
Associations Analysis Between Lifestyle and Osteoporosis
January 5, 2021 updated by: Zihui Tang, Shanghai Tongji Hospital, Tongji University School of Medicine
The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to which lifestyle was associated with osteoporosis among the Chinese population by using self-reported questionnaire methods.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to which lifestyle was associated with osteoporosis among the Chinese population by using self-reported questionnaire methods.
More than 3000 participants were recruited in communities in Shanghai.
Data involved in demographic information, lifestyle, dietary habits, medical history and clinical biomarkers were collected.
Every participants were measured bone mineral density (BMD g/cm2) at calcaneus by standardized quantitative ultrasound (QUS, Hologic Inc., Bedford, MA, USA) utilizing T-scores based on WHO criteria.
A standard statistical analysis including univariate and multiple variables regression analysis to explore the risk or preventive factors involved in Chinese lifestyle associated with osteoporosis.
Study Type
Observational
Enrollment (Actual)
3100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200040
- Huashan Hospital
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Shanghai, Shanghai, China, 200040
- Huasha Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
We performed a risk-factor study for osteoporosis using a random sample of the Chinese population.
Participants were recruited from rural and urban communities in Shanghai.
Survey participants aged 30-90 years were included in this study.
Description
Inclusion Criteria:
- Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.
Exclusion Criteria:
Some participants with chronic diseases and conditions that might potentially affect bone mass, structure, or metabolism were excluded. Briefly, the exclusion criteria were as follows: a history of
- serious residual effects of cerebral vascular disease;
- serious chronic renal disease (Glomerular filtration rate - GFR < 30 mL/min/1.73m2);
- serious chronic liver disease or alcoholism;
- significant chronic lung disease;
- corticosteroid therapy at pharmacologic levels;
- evidence of other metabolic or inherited bone disease, such as hyper- or hypoparathyroidism, Paget disease, osteomalacia, or osteogenesis imperfecta;
- recent (within the past year) major gastrointestinal disease, such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or significant chronic diarrhea;
- Cushing syndrome;
- hyperthyroidism; and
- any neurologic or musculoskeletal condition that would be a non-genetic cause of low bone mass.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Dr.Tang's research group
Chinese lifestyle associated with osteoporosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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osteoporosis accessed by Bone Mass Density (BMD)
Time Frame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks
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The bone mineral density (BMD g/cm2) was measured at calcaneus by standardized quantitative ultrasound (QUS, Hologic Inc., Bedford, MA, USA) utilizing T-scores based on WHO criteria, which were obtained from the automated equipment.
T-score refers to the ratio between patient's BMD and that of young adult population of same sex and ethnicity.
T-score of > -1 was taken as normal, between -1 and -2.5 osteopenic and < -2.5 as osteoporotic.
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participants will be measured for the duration of outpatient stay, an expected average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Zihui Tang, M.D and Ph.D, Huashan Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tang ZH, Zeng F, Li Z, Zhou L. Association and predictive value analysis for resting heart rate and diabetes mellitus on cardiovascular autonomic neuropathy in general population. J Diabetes Res. 2014;2014:215473. doi: 10.1155/2014/215473. Epub 2014 Mar 18.
- Tang ZH, Xiao P, Lei SF, Deng FY, Zhao LJ, Deng HY, Tan LJ, Shen H, Xiong DH, Recker RR, Deng HW. A bivariate whole-genome linkage scan suggests several shared genomic regions for obesity and osteoporosis. J Clin Endocrinol Metab. 2007 Jul;92(7):2751-7. doi: 10.1210/jc.2006-2607. Epub 2007 May 1.
- Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.
- Li X, Lei T, Tang Z, Dong J. Analyzing the association between fish consumption and osteoporosis in a sample of Chinese men. J Health Popul Nutr. 2017 Apr 19;36(1):13. doi: 10.1186/s41043-017-0088-y.
- Yu Q, Liu ZH, Lei T, Tang Z. Subjective evaluation of the frequency of coffee intake and relationship to osteoporosis in Chinese men. J Health Popul Nutr. 2016 Aug 5;35(1):24. doi: 10.1186/s41043-016-0060-2.
- Liu N, Zeng F, Zhang K, Tang Z. A community-based cross-sectional study for relationship of frequency of vegetables intake and osteoporosis in a Chinese postmenopausal women sample. BMC Womens Health. 2016 Jun 3;16:28. doi: 10.1186/s12905-016-0307-5.
- Yu CX, Zhang XZ, Zhang K, Tang Z. A cross-sectional study for estimation of associations between education level and osteoporosis in a Chinese men sample. BMC Musculoskelet Disord. 2015 Dec 9;16:382. doi: 10.1186/s12891-015-0839-0.
- Liu N, Chen J, Zhang K, Tang Z. A community-based study of the relationship between coronary artery disease and osteoporosis in Chinese postmenopausal women. Coron Artery Dis. 2016 Jan;27(1):59-64. doi: 10.1097/MCA.0000000000000306.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
April 13, 2015
First Submitted That Met QC Criteria
May 18, 2015
First Posted (Estimate)
May 22, 2015
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPLA_Dr.Tang
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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