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Associations Analysis Between Lifestyle and Osteoporosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Huashan Hospital
Information provided by (Responsible Party):
Zihui Tang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT02451397
First received: April 13, 2015
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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
Osteoporosis of Disuse With Current Pathological Fracture

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population

Resource links provided by NLM:


Further study details as provided by Shanghai Tongji Hospital, Tongji University School of Medicine:

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.


Enrollment: 3100
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dr.Tang's research group
Chinese lifestyle associated with osteoporosis

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.
  Eligibility

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 13, 2015
Last Updated: September 20, 2016

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

ClinicalTrials.gov processed this record on April 24, 2017