A Tiered Management System of Osteoporosis in China

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoporosis; Osteopenia
• Intervention / Treatment: Other: No intervention would be taken

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Weibo Xia, MD
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Hai Tang
    • Beijing, Beijing, China
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Yu Pei
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Chunli Song
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Shijingshan Hospital
      • Contact: Hongyu Dong
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Jishuitan Hospital
      • Contact: Liang He
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Jianming Hou
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Wen Wu
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Third Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Hospital of Xiangya,Central South University
      • Contact: Zhongjian Xie
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Hua Lin
    • Suzhou, Jiangsu, China
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
      • Contact: Youjia Xu
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Provincial People's Hospital
      • Contact: Yanan Huo
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The Fourth Hospital of Jilin University
      • Contact: Mengmeng Zhang
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital affiliated to China Medical University
      • Contact: Qin Fu
  • Ninxia
    • Yinchuan, Ninxia, China
      • Recruiting
      • People's Hospital of Ningxia Hui Autonomous Region
      • Contact: Jinhan Lv
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huadong Hospital affiliated to Fudan University
      • Contact: Qun Cheng
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • The Sixth People's Hospital affiliated to Shanghai Jiaotong University
      • Contact: Zhenlin Zhang
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai first people's hospital affiliated to Shanghai jiaotong university
      • Contact: Li You
    • Shanghai, Shanghai, China
      • Recruiting
      • Tongji Hospital Affiliated to Tongji University
      • Contact: Keqin Zhang
  • Shannxi
    • Xi'an, Shannxi, China
      • Recruiting
      • Xi'an Red Cross hospital
      • Contact: Yuhong Zeng
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • The First Affiliated Hospital of Shanxi Medical University
      • Contact: Jin Dong
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Decai Chen
    • Chengdu, Sichuan, China
      • Recruiting
      • Western Theater General Hospital
      • Contact: Xiaolan Jin
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Hospital
      • Contact: Aijun Chao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community population and outpatients in each clincal centre

Description

Inclusion Criteria:

• Postmenopausal women or men aged 50 years or older

Conform to the diagnosis of osteoporosis or osteopenia as followings:

1. 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
2. Have at least once major osteoporotic fracture

Exclusion Criteria:

• Screened people who do not meet the inclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients enrolled at year 1	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 1	Year 1
Number of patients enrolled at year 2	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 2	Year 2
Number of patients enrolled at year 3	The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3	Year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients screened at year 1	The number of patients screened for osteoporosis in each medical centre at year 1	Year 1
Number of patients screened at year 2	The number of patients screened for osteoporosis in each medical centre at year 2	Year 2
Number of patients screened at year 3	The number of patients screened for osteoporosis in each medical centre at year 3	Year 3
The proportion of patients treated in compliance with guidelines at year 1	The proportion of patients treated in compliance with guidelines at year 1	Year 1
The proportion of patients treated in compliance with guidelines at 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	The proportion of patients treated in compliance with guidelines at year 3	Year 3
Data integrity in network platform at year 1	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 1.	Year 1
Data integrity in network platform at year 2	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 2.	Year 2
Data integrity in network platform at year 3	The integrity of data recorded in network platform. Including general characteristics (name, sex, age, height, weight and race), medical history (onset age, chief complaint, history of fractures, medication history, previous history and family history), results of auxiliary examinations (DXEA is mandatory required, and other examinations may differ between medical centres, usually including serum calcium, serum phosphorus, serum total alkaline phosphatase, urine calcium, urine phosphorus, serum parathyroid hormone, X ray of vertebrae and so on), prescriptions, and follow-up data. At year 3.	Year 3

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: The propotion of patients treated in comliance with guidelines Xia, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: JS-1894

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