A retrospective multi-centre study of Osteo Signal AI software
Research type
Research Study
Full title
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
IRAS ID
363270
Contact name
Anupama Nandagudi
Contact email
Sponsor organisation
Promedius Inc
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
Osteoporosis is a progressive skeletal disease marked by decreased bone density and often leads to a high risk of bone fractures. Despite how common it is and the impact, osteoporosis remains both underdiagnosed and undertreated. In recent years, there have been developments in computer software that can provide useful information to help doctors in the diagnosis of such conditions. Osteo Signal is a software that has been developed for that purpose. This software uses information from standard chest x-rays to help identify patients at risk of osteoporosis and osteopenia (the stage before osteoporosis). It is important that any software used for this purpose is first validated to check it performs appropriately before being used in a clinical setting.
The purpose of this study is to help validate the performance of the Osteo Signal software. To do this a comparison will be made between the output of the Osteo Signal software and the results from a bone density scan (DXA). DXA scans are typically used in the NHS as a means of determining if a patient’s bone density falls into a category of normal, osteopenic or osteoporotic.
This study will be conducted in sites in the UK and the Netherlands. There will be no requirement for this study for any patient to undergo a new chest x-ray or DXA scan or any additional tests. Existing information will be used from patients who already have had a chest x-ray and DXA scan taken in the past.
It is hoped that the results of this study will help the future population of patients who are at risk of low bone density and the injuries that might result from that.REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0917
Date of REC Opinion
15 Dec 2025
REC opinion
Favourable Opinion