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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
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoporosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 31, 2023
Last Updated
July 7, 2023
Sponsor
National Defense Medical Center, Taiwan
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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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