China Action on Spine and Hip Status (CASH)

Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Osteoporosis; Liver Steatosis

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 Type: Observational
• Enrollment (Actual): 3457

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100035
      • Beijing ji shui tan hospitla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoporotic fractures	The spine osteoporotic fractures assessed on the lateral spine image of QCT exam	5 years
Bone mineral density (BMD) of spine and hip	BMD measurement at the spine by QCT and hip	5 years
liver steatosis	The liver steatosis assessed by QCT	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic syndrome	Diagnosis of metabolic syndrome and visceral fat	5 years
visceral fat measurement by QCT	visceral fat measurement and distribution assessed by QCT at the abdomen and hip	5 years
Osteoarthritis of spine and hip	OA assessment at spine and hip by CT images	5 years

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Collaborators: University of California, San Francisco; Fu Wai Hospital, Beijing, China; 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
• Investigators: Principal Investigator: xiaoguang cheng, MD, Beijing Ji Shui Tan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: osteoarthritis; obesity; osteoporosis; liver steatosis; bone mineral density; computed xray tomography
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Musculoskeletal Diseases; Insulin Resistance; Hyperinsulinism; Bone Diseases; Bone Diseases, Metabolic; Fatty Liver; Metabolic Syndrome; Osteoporosis
• Other Study ID Numbers: jst2012cash

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No