Osteoporosis of Disuse With Current Pathological FractureNCT02451397
Associations Analysis Between Lifestyle and Osteoporosis
An observational study of Osteoporosis of Disuse With Current Pathological Fracture, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis of Disuse With Current Pathological Fracture
- How many people
- 3,100 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2012to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.
Who cannot join
- 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
- serious residual effects of cerebral vascular disease;
- serious chronic renal disease (Glomerular filtration rate - GFR < 30 mL/min/1.73m2);
- serious chronic liver disease or alcoholism;
- significant chronic lung disease;
- corticosteroid therapy at pharmacologic levels;
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- evidence of other metabolic or inherited bone disease, such as hyper- or hypoparathyroidism, Paget disease, osteomalacia, or osteogenesis imperfecta;
- recent (within the past year) major gastrointestinal disease, such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or significant chronic diarrhea;
- Cushing syndrome;
- hyperthyroidism; and
- any neurologic or musculoskeletal condition that would be a non-genetic cause of low bone mass.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Huasha Hospital
Shanghai, Shanghai Municipality, 200040
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
Official title: The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
This is a cross-sectional study, and we do not assign specific interventions to the subjects of the study.
| Study group | Role | What they receive |
|---|---|---|
| Dr.Tang's research group | Chinese lifestyle associated with osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2012
- Primary completionAug 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis of Disuse With Current Pathological FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Zihui Tang, Huashan Hospital
- Investigators
- Zihui Tang, M.D and Ph.D, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451397
- Sponsor's protocol ID
- OPLA_Dr.Tang
- Status last verified
- Jan 2021
- First submitted
- 13 Apr 2015
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24772443Tang 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.
PubMed 17473065Tang 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.
PubMed 25287103Li 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.
PubMed 28424092Yu 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.
PubMed 27495290Liu 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.
PubMed 27259804Yu 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.
PubMed 26646811Liu 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.
PubMed 26398152
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Associations Analysis Between Lifestyle and Osteoporosis Among Chinese Population
- ClinicalTrials.gov ID
- NCT02451397
- Acronym / sponsor ID
- OPLA_Dr.Tang
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,100 participants (actual)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dr.Tang's research group | – | –Chinese lifestyle associated with osteoporosis |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a cross-sectional study, and we do not assign specific interventions to the subjects of the study. | Other | Dr.Tang's research group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 24772443Tang 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.
- Background: PubMed 17473065Tang 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.
- Background: PubMed 25287103Tang 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.
- Derived from this study: PubMed 28424092Li 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.
- Derived from this study: PubMed 27495290Yu 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.
- Derived from this study: PubMed 27259804Liu 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.
- Derived from this study: PubMed 26646811Yu 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.
- Derived from this study: PubMed 26398152Liu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zihui Tang, M.D and Ph.D principal investigator
Huashan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis of Disuse With Current Pathological Fracture, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451397, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.