Clinical trial NCT02451397: Associations Analysis Between Lifestyle and Osteoporosis
Official title: The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis of Disuse With Current Pathological Fracture
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
First posted: 2015-05-22
Enrollment: 3100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: osteoporosis accessed by Bone Mass Density (BMD)
timeFrame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huasha Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Zihui Tang, M.D and Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.