China Action on Spine and Hip Status (CASH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 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
Information provided by (Responsible Party):
xiaoguang Cheng, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT01758770
First received: December 26, 2012
Last updated: December 31, 2012
Last verified: December 2012
  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 compare the performance of QCT and DXA measured BMD in the diagnosis of osteoporosis.
  5. To investigate the association of body composition with osteoporosis

Condition
Osteoporotic Fracture
Osteoarthritis
Bone Mineral Density Quantitative

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: 3 years ] [ Designated as safety issue: No ]
    The spine osteoporotic fractures assessed on the lateral spine image of QCT exam


Secondary Outcome Measures:
  • Bone mineral density (BMD) of spine and hip [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    BMD measurement at the spine and hip by QCT and/or DXA

  • Body composition assessment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Fat and muscle mass measurement and distribution assessed by QCT at the abdomen and hip

  • Osteoarthritis of spine and hip [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    OA assessment at spine and hip by CT images


Estimated Enrollment: 3000
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (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 consisted of the female subjects over 55 years old and male subjects over 60 years old from the participants of the large-scale population-based study:the prospective urban rural epidemiology (PURE) in China. This study also included the randomly selected 20% subjects with blood sampling for all age of the PURE study.

Criteria
  1. Inclusion Criteria:

    1. Participants of the PURE study in China
    2. Females over 55 years old
    3. Males over 60 years old
    4. All the subjects randomly selected for blood sampling
    5. 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 0086-010-58516695 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    0086-010-58516695    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         
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
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: December 31, 2012
Health Authority: China: Ministry of Health

Keywords provided by Beijing Jishuitan Hospital:
osteoporosis
osteoarthritis
bone mineral density
computed xray tomography
body composition

Additional relevant MeSH terms:
Osteoarthritis
Osteoporotic Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 31, 2014