Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
Primary Purpose
Osteoporosis, Osteoporotic Fractures
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AI-enabled Chest X-ray-based Screening Tool
Sponsored by
About this trial
This is an interventional screening trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria: Patients recieved at least 1 chest X-ray examination in 2022 More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR Exclusion Criteria: Patients with history of at least 1 dual energy x-ray absorptiometry (DXA) Patients with history of osteoporosis or osteoportic fracture Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium) Patients died before 01 Jan 2023
Sites / Locations
- Tri-service general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Patients randomized to intervention will have access to the screening tool.
Patients randomized to control will continue routine practice.
Outcomes
Primary Outcome Measures
newly diagnosed with osteoporosis
After performing an chest X-ray, the osteoporosis was followed.
Secondary Outcome Measures
initiation of DXA examination
After performing an chest X-ray, the osteoporosis was followed.
initiation of anti-osteoporotic treatment
After performing an chest X-ray, the osteoporosis was followed.
Full Information
NCT ID
NCT05721157
First Posted
January 31, 2023
Last Updated
July 7, 2023
Sponsor
National Defense Medical Center, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05721157
Brief Title
Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
Official Title
Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteoporotic Fractures
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have access to the screening tool.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to control will continue routine practice.
Intervention Type
Other
Intervention Name(s)
AI-enabled Chest X-ray-based Screening Tool
Intervention Description
Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-Chest X-ray result was positive or negative.The system will send a message to corresponding physicians if positive finding.
Primary Outcome Measure Information:
Title
newly diagnosed with osteoporosis
Description
After performing an chest X-ray, the osteoporosis was followed.
Time Frame
Within 180 days
Secondary Outcome Measure Information:
Title
initiation of DXA examination
Description
After performing an chest X-ray, the osteoporosis was followed.
Time Frame
Within 180 days
Title
initiation of anti-osteoporotic treatment
Description
After performing an chest X-ray, the osteoporosis was followed.
Time Frame
Within 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients recieved at least 1 chest X-ray examination in 2022
More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR
Exclusion Criteria:
Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)
Patients with history of osteoporosis or osteoportic fracture
Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)
Patients died before 01 Jan 2023
Facility Information:
Facility Name
Tri-service general hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
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