Osteoporosis of Disuse With Current Pathological Fracture Clinical Trial
Official title:
The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
| NCT number | NCT02451397 |
| Other study ID # | OPLA_Dr.Tang |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | December 2020 |
| Verified date | January 2021 |
| Source | Shanghai Tongji Hospital, Tongji University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3100 |
| Est. completion date | December 2020 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 90 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Huasha Hospital | Shanghai | Shanghai |
| China | Huashan Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Huashan Hospital |
China,
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. — View 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. Epub 2007 May 1. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | osteoporosis accessed by Bone Mass Density (BMD) | 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. | participants will be measured for the duration of outpatient stay, an expected average of 2 weeks |