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Completed

NCT Number: NCT01758770

China Action on Spine and Hip Status

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

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Key information

Conditions

Osteoporosis Arthritis Body Weight Bone Diseases Bone Diseases, Metabolic Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Joint Diseases Liver Diseases Liver Steatosis Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

29 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing ji shui tan hospitla

Beijing, Beijing Municipality, 100035, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Participants of the PURE study in China (PURE China study)
  • be willing to and be able to join in the study and signed Informed consent
  • Exclusion Criteria:
  • Pregnant
  • Spine and both hip implants

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: CASH

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 1, 2013
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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