China Action on Spine and Hip Status (CASH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Beijing Jishuitan Hospital
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
University of California, San Francisco
Beijing Shi Jing Shan hospital,Beijing, China
Beijing Shun Yi traditional 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
Shen Yang Red Cross hospital,shen yang, liaoning
Information provided by (Responsible Party):
xiaoguang Cheng, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01758770
First received: December 26, 2012
Last updated: August 20, 2015
Last verified: August 2015
  Purpose
  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
Osteoporosis
Liver Steatosis
Metabolic Syndrome
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)

Resource links provided by NLM:


Further study details as provided by Beijing Jishuitan Hospital:

Primary Outcome Measures:
  • Osteoporotic fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The spine osteoporotic fractures assessed on the lateral spine image of QCT exam

  • liver steatosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The liver steatosis assessed by QCT

  • metabolic syndrome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    the diagnosis of metabolic syndrome and visceral fat


Secondary Outcome Measures:
  • Bone mineral density (BMD) of spine and hip [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    BMD measurement at the spine by QCT and hip

  • visceral fat measurement by QCT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    visceral fat measurement and distribution assessed by QCT at the abdomen and hip

  • Osteoarthritis of spine and hip [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    OA assessment at spine and hip by CT images


Estimated Enrollment: 6000
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   29 Years and older
Genders Eligible for Study:   Both
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.

Criteria
  1. Inclusion Criteria:

    1. Participants of the PURE study in China
    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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758770

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

Locations
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
Beijing Shun Yi traditional 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
Shen Yang Red Cross hospital,shen yang, liaoning
Investigators
Principal Investigator: xiaoguang cheng, MD Beijing ji shui tan hospital
  More Information

No publications provided

Responsible Party: xiaoguang Cheng, Chairman, department of radiology, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT01758770     History of Changes
Other Study ID Numbers: jst2012cash
Study First Received: December 26, 2012
Last Updated: August 20, 2015
Health Authority: China: Ministry of Health

Keywords provided by Beijing Jishuitan Hospital:
osteoporosis
osteoarthritis
bone mineral density
computed xray tomography
liver steatosis
obesity

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

ClinicalTrials.gov processed this record on August 27, 2015