China Action on Spine and Hip Status

Obesity Clinical Trial

— CASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758770
• Other study ID #: jst2012cash
• Status: Completed
• Phase: N/A
• First received: December 26, 2012
• Last updated: March 5, 2018
• Start date: October 2012
• Est. completion date: July 26, 2017

Study information

• Verified date: March 2018
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3457
• Est. completion date: July 26, 2017
• Est. primary completion date: July 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Steatosis
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Osteoporosis

Locations

Country	Name	City	State
China	Beijing ji shui tan hospitla	Beijing	Beijing

Sponsors (14)

Lead Sponsor

Collaborator

Beijing Jishuitan Hospital

Affiliate hospital of jiangxi Traditional Chinese Medicine university, Beijing Shi Jing Shan hospital,Beijing, China, Chang Zhou Wu Jin Traditional Chinese Medicine hospital, Cheng Du Da Yi hospital,Cheng du, Sichuan, Chengdu Second people's hospital, Fu Wai Hospital, Beijing, China, No 1 TCM hospital of Jiangsu, No 2 TCM hospital of Jiangsu, Red cross hospital of Shaanxi, Second hospital of sichuan university,Cheng du, Sichuan, Shen Yang 4th hospital,shen yang, liaoning, Tai yuan central hospital,taiyuan, shanxi, University of California, San Francisco

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoporotic fractures	The spine osteoporotic fractures assessed on the lateral spine image of QCT exam	5 years
Primary	Bone mineral density (BMD) of spine and hip	BMD measurement at the spine by QCT and hip	5 years
Primary	liver steatosis	The liver steatosis assessed by QCT	5 years
Secondary	Metabolic syndrome	Diagnosis of metabolic syndrome and visceral fat	5 years
Secondary	visceral fat measurement by QCT	visceral fat measurement and distribution assessed by QCT at the abdomen and hip	5 years
Secondary	Osteoarthritis of spine and hip	OA assessment at spine and hip by CT images	5 years