A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporos… (NCT07421713) | Clinical Trial Compass
RecruitingNot Applicable
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
Netherlands, United Kingdom595 participantsStarted 2026-02-10
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Age ≥50 years at the time of chest X-ray
✓. Availability of
✓. Posteroanterior (PA) Chest X-ray and
✓. DXA scan with a valid T-score measurement where both the DXA scan and Chest x-ray examinations were performed within 6 months (182 days) of each other and
✓. Available X-ray and DXA scans performed on or after 01-Jan-2010.
✓. Complete metadata (sex and age) available on PACS or hospital records.
Exclusion criteria
✕. Non-diagnostic Quality or Incomplete Imaging of:
✕. DXA scan inadequacy: Missing T-score from a technically inadequate scan.
✕. PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata.
✕. Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis
What they're measuring
1
Two class bone status classification (osteoporosis/non osteoporosis)
Timeframe: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
✕. PA Chest X-ray \> ±6 months from the date of the DXA scan.
✕. Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.
✕. diagnosis of osteoporosis (T-score ≤-2.5), or current/recent anti- osteoporotic medications, within 12 months prior to the DXA scan used in the study.
✕. Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study.