We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

China Action on Spine and Hip Status (CASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758770
Recruitment Status : Recruiting
First Posted : January 1, 2013
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):

Study Description
Brief 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. To investigate the association of body composition with osteoporosis
  5. To investigate the prevalence of liver steatosis in China
  6. To investigate the application of QCT fat measurement

Condition or disease
Osteoporosis Liver Steatosis Metabolic Syndrome Obesity

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

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)
Actual Study Start Date : October 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Osteoporotic fractures [ Time Frame: 5 years ]
    The spine osteoporotic fractures assessed on the lateral spine image of QCT exam

  2. Bone mineral density (BMD) of spine and hip [ Time Frame: 5 years ]
    BMD measurement at the spine by QCT and hip

  3. liver steatosis [ Time Frame: 5 years ]
    The liver steatosis assessed by QCT

Secondary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: 5 years ]
    Diagnosis of metabolic syndrome and visceral fat

  2. visceral fat measurement by QCT [ Time Frame: 5 years ]
    visceral fat measurement and distribution assessed by QCT at the abdomen and hip

  3. Osteoarthritis of spine and hip [ Time Frame: 5 years ]
    OA assessment at spine and hip by CT images

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   29 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
  1. Inclusion Criteria:

    1. Participants of the PURE study in China (PURE China study)
    2. be willing to and be able to join in the study and signed Informed consent
  2. Exclusion Criteria:

    1. Pregnant
    2. Spine and both hip implants
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758770

Contact: xiaoguang Cheng, MD 0086-010-58516947 xiao65@263.net
Contact: yongbin su, MD 0086-010-58516688 ext 6196 dazaiqianyuan@126.com

China, Beijing
Beijing ji shui tan hospitla Recruiting
Beijing, Beijing, China, 100035
Contact: xiaoguang cheng, MD    0086-010-58516947    xiao65@263.net   
Contact: yongbin su, MD    0086-010-58516688 ext 6196    dazaiqianyuan@126.com   
Sub-Investigator: ling wang, MD         
Sub-Investigator: yimin ma, MD         
Sub-Investigator: yong zhang, MD         
Sponsors and Collaborators
Beijing Jishuitan Hospital
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
Principal Investigator: xiaoguang cheng, MD Beijing ji shui tan hospital
More Information

Responsible Party: xiaoguang Cheng, Chairman, department of radiology, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT01758770     History of Changes
Other Study ID Numbers: jst2012cash
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by xiaoguang Cheng, Beijing Jishuitan Hospital:
bone mineral density
computed xray tomography
liver steatosis

Additional relevant MeSH terms:
Metabolic Syndrome X
Fatty Liver
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Liver Diseases
Digestive System Diseases