Osteoporosis, Osteopenia
Conditions
Keywords
Osteoporosis, Bone Diseases, Metabolic
Brief 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.
Interventions
DEVICEOsteo Signal
Artificial Intelligence (AI) software
Sponsors
Promedius Inc
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥50 years at the time of chest X-ray 2. Availability of 1. Posteroanterior (PA) Chest X-ray and 2. 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 3. Available X-ray and DXA scans performed on or after 01-Jan-2010. 3. Complete metadata (sex and age) available on PACS or hospital records.
Exclusion criteria
1. Non-diagnostic Quality or Incomplete Imaging of: 1. DXA scan inadequacy: Missing T-score from a technically inadequate scan. 2. PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata. 3. Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis 4. PA Chest X-ray \> ±6 months from the date of the DXA scan. 2. Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study. 1. 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. 2. Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study. 3. Diagnosis of any metabolic bone disease prior to the DXA scan used in the study. 4. Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan. 5. Major Chest Wall or Spinal Deformities, including but not limited to: 1. Severe structural deformities: Thoracic scoliosis with Cobb angle \>40°, severe kyphosis, or chest wall deformities (pectus excavatum/carinatum) affecting \>30% of the thoracic cage. 2. Surgical hardware: Previous thoracic/spinal surgery with metallic implants obscuring anatomical landmarks required for AI analysis. 3. Pathological conditions: Extensive pulmonary consolidation, pleural effusion, lesions or masses obscuring \>30% of thoracic skeletal structures 6. Subject has opted out of confidential data being used for research purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two class bone status classification (osteoporosis/non osteoporosis) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Three class bone status classification (osteoporosis/osteopenia/normal) | 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 |
| Classification for osteoporosis and osteopenia | 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 |
Countries
Netherlands, United Kingdom
Contacts
CONTACTKim Bensalem
CONTACTJung Jinho
PRINCIPAL_INVESTIGATORJacob J Visser, Musculoskeletal Radiologist
Erasmus Medical Center
Outcome results
None listed