Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray

Sponsor

National Defense Medical Center, Taiwan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721157

Collaborator

(none)

1,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray

Condition or Disease	Intervention/Treatment	Phase
Chest X-ray Osteoporosis	Other: AI-enabled Chest X-ray-based Screening Tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients randomized to intervention will have access to the screening tool.	Other: AI-enabled Chest X-ray-based Screening Tool 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.
No Intervention: Control Patients randomized to control will continue routine practice.

Arm

Intervention/Treatment

Experimental: Intervention

Patients randomized to intervention will have access to the screening tool.

Other: AI-enabled Chest X-ray-based Screening Tool

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.

No Intervention: Control

Patients randomized to control will continue routine practice.

Outcome Measures

Primary Outcome Measures

New-diagnoitic event [Within 7days]
After performing an chest X-ray, the osteoporosis was followed.
All cause mortality (death) [Within 365 days]
After performing an chest X-ray, the patient's survival is tracked.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients recieved at least 1 Chest X-ray examination in 2022.

Exclusion Criteria:

Patients recieved at least 1 dual energy x-ray absorptiometry(DXA) examination in 2021~2022.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Defense Medical Center, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chin Lin, Associate Professor, National Defense Medical Center, Taiwan

ClinicalTrials.gov Identifier:

NCT05721157

Other Study ID Numbers:

NDMC2023001

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Study Results

No Results Posted as of Feb 9, 2023