A Tiered Management System of Osteoporosis in China

April 12, 2019 updated by: Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients enrolled at year 1
Time Frame: 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
Time Frame: 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
Time Frame: Year 3
The number of patients with osteoporosis or osteopenia enrolled in each medical centre at year 3
Year 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients screened at year 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Year 3
The proportion of patients treated in compliance with guidelines at year 3
Year 3
Data integrity in network platform at year 1
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: The propotion of patients treated in comliance with guidelines Xia, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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