Associations Analysis Between Lifestyle and Osteoporosis

Completed

• Conditions: Osteoporosis of Disuse With Current Pathological Fracture

• Registration Number: NCT02451397
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-22
• Primary Completion: 2018-08
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
osteoporosis accessed by Bone Mass Density (BMD)	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.

Trial Locations

Locations (2)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Huasha Hospital; 🇨🇳 Shanghai, Shanghai, China