We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : September 22, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

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

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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

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 :
  1. 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.


Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
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
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
Principal Investigator: Zihui Tang, M.D and Ph.D Huashan Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zihui Tang, M.D and Ph.D, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02451397     History of Changes
Other Study ID Numbers: OPLA_Dr.Tang
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Osteoporosis
Fractures, Spontaneous
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Fractures, Bone
Wounds and Injuries