NCT05721157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,912

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

January 31, 2023

Last Update Submit

July 7, 2023

Conditions

OsteoporosisOsteoporotic Fractures

Outcome Measures

Primary Outcomes (1)

  • newly diagnosed with osteoporosis

    After performing an chest X-ray, the osteoporosis was followed.

    Within 180 days

Secondary Outcomes (2)

  • initiation of DXA examination

    Within 180 days

  • initiation of anti-osteoporotic treatment

    Within 180 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control

NO INTERVENTION

Patients randomized to control will continue routine practice.

Interventions

AI-enabled Chest X-ray-based Screening ToolOTHER

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.

Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service general hospital

Taipei, 11490, Taiwan

Location

MeSH Terms

Conditions

OsteoporosisOsteoporotic Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)