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临床试验/NCT03916289
NCT03916289Unknown不适用

Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study

Peking Union Medical College Hospital25 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2018年11月1日最近更新:
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适应症

试验速览

阶段
不适用
入组人数
15,000
试验地点
25
主要终点
Number of patients enrolled at year 1
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

There is a management gap in China. This study aims to establish a tiered management system of osteoporosis for Chinese patients. Including:

  1. Developing a national hierarchical health management network platform for middle-aged and elderly osteoporosis patients. With this platform, the data of medical records, laboratory results would be shared between medical institutions. And primary hospitals can refer the patients to the nearest medical centre for advanced auxiliary examinations and diagnosis.
  2. Establishing a muti-level hospital collaboration, doctor-patient interaction management model of osteoporosis.
  3. To explore and establish a early warning and screening pathways for osteoporosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Postmenopausal women or men aged 50 years or older
  • •Conform to the diagnosis of osteoporosis or osteopenia as followings:
  • •Bone mineral density measured by dual-energy X-ray absorptiometry show a T-score ≤ -1.0 at neck of femur or total hip or lumber 1-4 OR
  • •Have at least once major osteoporotic fracture

排除标准

  • •Screened people who do not meet the inclusion criteria

结局指标

主要结局

Number of patients enrolled at year 1

时间窗: Year 1

The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1

Number of patients enrolled at year 2

时间窗: Year 2

The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 2

Number of patients enrolled at year 3

时间窗: Year 3

The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3

次要结局

  • Number of patients screened at year 1(Year 1)
  • Number of patients screened at year 2(Year 2)
  • The proportion of patients treated in compliance with guidelines at year 2(Year 2)
  • The proportion of patients treated in compliance with guidelines at year 3(Year 3)
  • Data integrity in network platform at year 1(Year 1)
  • Number of patients screened at year 3(Year 3)
  • The proportion of patients treated in compliance with guidelines at year 1(Year 1)
  • Data integrity in network platform at year 2(Year 2)
  • Data integrity in network platform at year 3(Year 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (25)

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