OsteoporosisCASHNCT01758770
China Action on Spine and Hip Status
An observational study of Osteoporosis and Liver Steatosis, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
1. To determine the prevalences of osteoporotic fracture in elderly Chinese population. 2. To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD measurement. 3. To investigate the difference in the prevalences of osteoporosis between cities and urban-rural area in China. 4. Read more about this study
- Who is it for?
- Ages 29 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Liver Steatosis, Metabolic Syndrome
- How many people
- 3,457 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to 26 Jul 2017
- 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 29 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a population-based study, the population of this study is the subset of participants of the large-scale population-based study:the prospective urban rural epidemiology (PURE) in China.
- Inclusion Criteria:
- Participants of the PURE study in China (PURE China study)
- be willing to and be able to join in the study and signed Informed consent
- Exclusion Criteria:
- Pregnant
- Spine and both hip implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)
- To determine the prevalences of osteoporotic fracture in elderly Chinese population.
- To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD measurement.
- To investigate the difference in the prevalences of osteoporosis between cities and urban-rural area in China.
- To investigate the association of body composition with osteoporosis
- To investigate the prevalence of liver steatosis in China
- To investigate the application of QCT fat measurement
Read the detailed description
Osteoporosis and osteoarthritis (OA) both are very common in elderly population,it is particular important for China with a huge aging population in the coming years.Bone mineral density measured by quantitative computed tomography (QCT) or dual energy X-ray absorptiometry (DXA) is the surrogate for bone health status and diagnosis of osteoporosis and OA. In this study we utilize the large-scale population based epidemiology study (PURE) population,spine and hip QCT and/or DXA will be obtained for the subject to investigate the prevalence of osteoporosis and osteoarthritis in elderly Chinese population. We also study the relation between bone mineral density with osteoporotic fracture and OA More than 3000 subjects selected from the PURE study participants in Beijing and other centers in China will be recruited to this study. More precisely, the subjects are consisted of the females over 55 years and males over 60 years old, along with the 20% randomly selected PURE participants for blood sampling.
Beijing ji shui tan hospital will be the coordinate center for the whole study, Beijing shi jing shan hospital, Beijing shun yi traditional medicine hospital and Taiyuan central hospital of shanxi will participate, other centers may be added late.
Bone mineral density of spine and hip will be measured with QCT and/or DXA. Quantitative computed tomography QCT pro (Mindways software, inc. USA) will be used for all QCT measurement, the CT scanner will be the clinical CT scanner of the local participated center.
Quality control and monitoring will be conducted by Beijing ji shui tan hospital, as well as the centralised image interpretation.
Therefore, this study is designed to provide the current and reliable prevalence of osteoporotic fracture, osteoporosis, OA in elderly Chinese population using QCT and/or DXA. The performance of QCT and DXA in the diagnosis of osteoporosis , as well as the association of body composition with osteoporosis will be assessed.
- Conditions
- Osteoporosis, Liver Steatosis, Metabolic Syndrome, Obesity
- Keywords
- osteoporosis, osteoarthritis, bone mineral density, computed xray tomography, liver steatosis, obesity
- Medical subject headings
- Osteoporosis, Fatty Liver, Metabolic Syndrome, Obesity, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporotic fractures
The spine osteoporotic fractures assessed on the lateral spine image of QCT exam
Measured: 5 years
Bone mineral density (BMD) of spine and hip
BMD measurement at the spine by QCT and hip
Measured: 5 years
liver steatosis
The liver steatosis assessed by QCT
Measured: 5 years
Secondary outcomes (3)
Metabolic syndrome
Diagnosis of metabolic syndrome and visceral fat
Measured: 5 years
visceral fat measurement by QCT
visceral fat measurement and distribution assessed by QCT at the abdomen and hip
Measured: 5 years
Osteoarthritis of spine and hip
OA assessment at spine and hip by CT images
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startOct 2012
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 3,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, University of California, San Francisco, Beijing Shi Jing Shan hospital,Beijing, China, Tai yuan central hospital,taiyuan, shanxi, Cheng Du Da Yi hospital,Cheng du, Sichuan, Shen Yang 4th hospital,shen yang, liaoning, Second hospital of sichuan university,Cheng du, Sichuan, Chang Zhou Wu Jin Traditional Chinese Medicine hospital, Red cross hospital of Shaanxi, No 1 TCM hospital of Jiangsu, No 2 TCM hospital of Jiangsu, Chengdu Second people's hospital, Affiliate hospital of jiangxi Traditional Chinese Medicine university
- Responsible party
- Principal investigator, xiaoguang Cheng, Beijing Jishuitan Hospital
- Investigators
- xiaoguang cheng, MD, Principal investigator, Beijing ji shui tan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758770
- Sponsor's protocol ID
- jst2012cash
- Acronym
- CASH
- Status last verified
- Mar 2018
- First submitted
- 26 Dec 2012
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)
- ClinicalTrials.gov ID
- NCT01758770
- Acronym / sponsor ID
- CASH / jst2012cash
- Conditions
- Osteoporosis, Liver Steatosis, Metabolic Syndrome, Obesity
- Keywords
- osteoporosis, osteoarthritis, bone mineral density, computed xray tomography, liver steatosis, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,457 participants (actual)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, University of California, San Francisco, Beijing Shi Jing Shan hospital,Beijing, China, Tai yuan central hospital,taiyuan, shanxi, Cheng Du Da Yi hospital,Cheng du, Sichuan, Shen Yang 4th hospital,shen yang, liaoning, Second hospital of sichuan university,Cheng du, Sichuan, Chang Zhou Wu Jin Traditional Chinese Medicine hospital, Red cross hospital of Shaanxi, No 1 TCM hospital of Jiangsu, No 2 TCM hospital of Jiangsu, Chengdu Second people's hospital, Affiliate hospital of jiangxi Traditional Chinese Medicine university
- Study start
- Oct 2012 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 1 Jan 2013 (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.
- To determine the prevalences of osteoporotic fracture in elderly Chinese population.
- To determine the prevalences of osteoporosis in elderly Chinese population using QCT BMD measurement.
- To investigate the difference in the prevalences of osteoporosis between cities and urban-rural area in China.
- To investigate the association of body composition with osteoporosis
- To investigate the prevalence of liver steatosis in China
- To investigate the application of QCT fat measurement
Detailed description
Osteoporosis and osteoarthritis (OA) both are very common in elderly population,it is particular important for China with a huge aging population in the coming years.Bone mineral density measured by quantitative computed tomography (QCT) or dual energy X-ray absorptiometry (DXA) is the surrogate for bone health status and diagnosis of osteoporosis and OA. In this study we utilize the large-scale population based epidemiology study (PURE) population,spine and hip QCT and/or DXA will be obtained for the subject to investigate the prevalence of osteoporosis and osteoarthritis in elderly Chinese population. We also study the relation between bone mineral density with osteoporotic fracture and OA More than 3000 subjects selected from the PURE study participants in Beijing and other centers in China will be recruited to this study. More precisely, the subjects are consisted of the females over 55 years and males over 60 years old, along with the 20% randomly selected PURE participants for blood sampling.
Beijing ji shui tan hospital will be the coordinate center for the whole study, Beijing shi jing shan hospital, Beijing shun yi traditional medicine hospital and Taiyuan central hospital of shanxi will participate, other centers may be added late.
Bone mineral density of spine and hip will be measured with QCT and/or DXA. Quantitative computed tomography QCT pro (Mindways software, inc. USA) will be used for all QCT measurement, the CT scanner will be the clinical CT scanner of the local participated center.
Quality control and monitoring will be conducted by Beijing ji shui tan hospital, as well as the centralised image interpretation.
Therefore, this study is designed to provide the current and reliable prevalence of osteoporotic fracture, osteoporosis, OA in elderly Chinese population using QCT and/or DXA. The performance of QCT and DXA in the diagnosis of osteoporosis , as well as the association of body composition with osteoporosis will be assessed.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a population-based study, the population of this study is the subset of participants of the large-scale population-based study:the prospective urban rural epidemiology (PURE) in China.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Osteoporotic fractures
Time frame: 5 years
The spine osteoporotic fractures assessed on the lateral spine image of QCT exam
Bone mineral density (BMD) of spine and hip
Time frame: 5 years
BMD measurement at the spine by QCT and hip
liver steatosis
Time frame: 5 years
The liver steatosis assessed by QCT
3 secondary outcomes
Metabolic syndrome
Time frame: 5 years
visceral fat measurement by QCT
Time frame: 5 years
Osteoarthritis of spine and hip
Time frame: 5 years
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 Mar 2018.
- Individual participant dataSharing planned: No
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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.
xiaoguang cheng, MD principal investigator
Beijing ji shui tan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Liver Steatosis, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Osteoporotic fractures (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2018.