Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)

Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteoporotic Fractures
• Intervention / Treatment: Other: AI-enabled Chest X-ray-based Screening Tool

• Study Type: Interventional
• Enrollment (Actual): 4912
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
newly diagnosed with osteoporosis	After performing an chest X-ray, the osteoporosis was followed.	Within 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
initiation of DXA examination	After performing an chest X-ray, the osteoporosis was followed.	Within 180 days
initiation of anti-osteoporotic treatment	After performing an chest X-ray, the osteoporosis was followed.	Within 180 days

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporotic Fractures
• Other Study ID Numbers: NDMC2023001

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