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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorPromedius Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

PA Chest X-ray > ±6 months from the date of the DXA scan.

Trial population

Patients selected hospitals in the Netherlands and UK that have previously had chest x-rays and DXA scans

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Osteo Signal

    Device

    Artificial Intelligence (AI) software

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Two class bone status classification (osteoporosis/non osteoporosis)

Device output against the lowest DXA as measured by sensitivity, specificity, and area under the ROC curve (AUC)

Time frame
At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other

Secondary outcomes

1

Three class bone status classification (osteoporosis/osteopenia/normal)

Device output against the lowest DXA as measured by area under the ROC curve (AUC), overall per cent agreement, and weighted Cohen's kappa

Time frame
At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
2

Classification for osteoporosis and osteopenia

Positive predictive value (PPV) and negative predictive value (NPV) for osteoporosis and osteopenia classifications

Time frame
At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other

Other outcomes

Sponsors and contacts

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