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Trial record 29 of 165 for:    Recruiting, Not yet recruiting, Available Studies | Osteoporosis

A Tiered Management System of Osteoporosis in China

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ClinicalTrials.gov Identifier: NCT03916289
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Osteoporosis Osteopenia Other: No intervention would be taken

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Establishing A National Tiered Diagnosis and Treatment System of Osteoporosis in China: A Pilot Study
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis


Intervention Details:
  • Other: No intervention would be taken
    No intervention would be taken. Patients enrolled would be managed by this tiered diagnosis and treatment system and receive standard treatment according to clinical guidelines of osteoporosis.


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community population and outpatients in each clincal centre
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916289


Contacts
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Contact: Weibo Xia, MD +86 69151552 xiaweibo8301@163.com

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

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03916289     History of Changes
Other Study ID Numbers: JS-1894
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases