Clinical trial NCT01758770: China Action on Spine and Hip Status
Official title: Multi Center Survey on Spine and Hip Status in Chinese Population Using Quantitative Computed Tomography (QCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Liver Steatosis
Metabolic Syndrome
Obesity
Keywords: osteoporosis
osteoarthritis
bone mineral density
computed xray tomography
liver steatosis
obesity
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
name: University of California, San Francisco
name: Beijing Shi Jing Shan hospital,Beijing, China
name: Tai yuan central hospital,taiyuan, shanxi
name: Cheng Du Da Yi hospital,Cheng du, Sichuan
name: Shen Yang 4th hospital,shen yang, liaoning
name: Second hospital of sichuan university,Cheng du, Sichuan
name: Chang Zhou Wu Jin Traditional Chinese Medicine hospital
name: Red cross hospital of Shaanxi
name: No 1 TCM hospital of Jiangsu
name: No 2 TCM hospital of Jiangsu
name: Chengdu Second people's hospital
name: Affiliate hospital of jiangxi Traditional Chinese Medicine university
First posted: 2013-01-01
Enrollment: 3457
Sex: ALL
Minimum age (years): 29
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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.

Brief 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

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 criteria: 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

Primary outcomes:
measure: Osteoporotic fractures
timeFrame: 5 years
measure: Bone mineral density (BMD) of spine and hip
timeFrame: 5 years
measure: liver steatosis
timeFrame: 5 years
Secondary outcomes:
measure: Metabolic syndrome
timeFrame: 5 years
measure: visceral fat measurement by QCT
timeFrame: 5 years
measure: Osteoarthritis of spine and hip
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing ji shui tan hospitla
state: Beijing
Study officials:
affiliation: Beijing ji shui tan hospital
name: xiaoguang cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: