Trial record 1 of 1 for: NCT02451397

Previous Study | Return to List | Next Study

Associations Analysis Between Lifestyle and 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. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02451397

Recruitment Status : Active, not recruiting

First Posted : May 22, 2015

Last Update Posted : March 20, 2019

Sponsor:

Collaborator:

Huashan Hospital

Information provided by (Responsible Party):

Zihui Tang, Huashan Hospital

Study Description

Brief Summary:

Condition or disease
Osteoporosis of Disuse With Current Pathological Fracture

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 Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	3100 participants
Observational Model:	Ecologic or Community
Time Perspective:	Cross-Sectional
Official Title:	The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
Study Start Date :	January 2012
Actual Primary Completion Date :	August 2018
Estimated Study Completion Date :	December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Dr.Tang's research group Chinese lifestyle associated with osteoporosis

Outcome Measures

Primary Outcome Measures :

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 ]
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.

Eligibility Criteria

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.

Layout table for eligibility information

Ages Eligible for Study:	30 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

Criteria

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
1. serious residual effects of cerebral vascular disease;
2. serious chronic renal disease (Glomerular filtration rate - GFR < 30 mL/min/1.73m2);
3. serious chronic liver disease or alcoholism;
4. significant chronic lung disease;
5. corticosteroid therapy at pharmacologic levels;
6. evidence of other metabolic or inherited bone disease, such as hyper- or hypoparathyroidism, Paget disease, osteomalacia, or osteogenesis imperfecta;
7. recent (within the past year) major gastrointestinal disease, such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or significant chronic diarrhea;
8. Cushing syndrome;
9. hyperthyroidism; and
10. any neurologic or musculoskeletal condition that would be a non-genetic cause of low bone mass.

Contacts and Locations

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): NCT02451397

Locations

Layout table for location information

China, Shanghai
Huasha Hospital
Shanghai, Shanghai, China, 200040
Huashan Hospital
Shanghai, Shanghai, China, 200040

Sponsors and Collaborators

Shanghai Tongji Hospital, Tongji University School of Medicine

Huashan Hospital

Investigators

Layout table for investigator information

Principal Investigator:	Zihui Tang, M.D and Ph.D	Huashan Hospital

More Information

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. 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Zihui Tang, M.D and Ph.D, Huashan Hospital
ClinicalTrials.gov Identifier:	NCT02451397
Other Study ID Numbers:	OPLA_Dr.Tang
First Posted:	May 22, 2015 Key Record Dates
Last Update Posted:	March 20, 2019
Last Verified:	March 2019

Additional relevant MeSH terms:

Layout table for MeSH terms

Osteoporosis Fractures, Spontaneous Bone Diseases, Metabolic Bone Diseases	Musculoskeletal Diseases Metabolic Diseases Fractures, Bone Wounds and Injuries

To Top