Actively Recruiting

Age: 50Years +
All Genders
Healthy Volunteers
NCT07421713

A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older

Led by Promedius Inc · Updated on 2026-02-19

595

Participants Needed

3

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to assess the performance of an artificial intelligence software (Osteo Signal) in detecting osteoporosis risk in adults 50 years and older. The main question it aims to answer is: What is the accuracy of the software in detecting osteoporosis risk on chest x-ray images as compared to the standard technique of dual-energy x-ray absorptiometry (DXA)? There is no direct involvement of participants in this study as it will use data from individuals who have already had a chest x-ray and a DXA scan taken in the past.

CONDITIONS

Official Title

A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older at the time of chest x-ray
  • Availability of posteroanterior (PA) chest x-ray and DXA scan with a valid T-score measurement
  • Both DXA scan and chest x-ray performed within 6 months (182 days) of each other
  • X-ray and DXA scans performed on or after January 1, 2010
  • Complete metadata (sex and age) available on PACS or hospital records
Not Eligible

You will not qualify if you...

  • Non-diagnostic quality or incomplete imaging of DXA or chest x-ray
  • DXA scans missing T-score or technically inadequate
  • Chest x-rays that are non-PA projection, have motion artifacts, inadequate thoracic visualization, or missing metadata
  • Image format incompatibility such as non-DICOM or corrupted files
  • Chest x-ray more than 6 months from the date of the DXA scan
  • Previous diagnosis or treatment of osteoporosis within 12 months before the DXA scan
  • Use of anti-osteoporotic medications for 3 months continuously before the chest x-ray
  • Diagnosis of any metabolic bone disease prior to the DXA scan
  • Diagnosis of metabolic bone disease other than osteoporosis or osteopenia up to 3 months after DXA scan
  • Major chest wall or spinal deformities including severe scoliosis with Cobb angle over 40°, severe kyphosis, chest wall deformities affecting more than 30% of thoracic cage
  • Previous thoracic or spinal surgery with metallic implants obscuring landmarks
  • Extensive pulmonary consolidation, pleural effusion, lesions, or masses obscuring more than 30% of thoracic skeletal structures
  • Subject has opted out of confidential data use for research purposes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Erasmus University Medical Center Rotterdam,

Rotterdam, Netherlands, 3015 GD

Not Yet Recruiting

2

Mid and South Essex NHS Foundation Trust

Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY

Not Yet Recruiting

3

Barts Health NHS Trust

London, United Kingdom, E1 4DG

Actively Recruiting

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Research Team

K

Kim Bensalem

CONTACT

J

Jung Jinho

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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