Osteo Signal
DeviceArtificial Intelligence (AI) software
NCT Number: NCT07421713
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.
Interested in participating?
Request Info50 year and older
All sexes
Observational
Erasmus University Medical Center Rotterdam,, Rotterdam, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Artificial Intelligence (AI) software
Time frame: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other
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
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
Positive predictive value (PPV) and negative predictive value (NPV) for osteoporosis and osteopenia classifications
Contact information is provided by the study sponsor or research team.
Jung Jinho
CONTACT
Kim Bensalem
CONTACT
Promedius Inc
Industry
A Retrospective Multi-centre Paired Accuracy Study to Evaluate the Performance of Osteo Signal Against the Dual-energy X-ray Absorptiometry (DXA) for Opportunistic Osteoporosis Screening.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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