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Validation of the AI-enabled software tool for utilizing a traditional chest X-ray to screen for osteoporosis and related fracture risk

A clinical validation study to test and compare the accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Solutions Tool), a fully automated AI enabled digital health tech solutions system for screening Osteoporosis & Osteopenia and its associated high future risk for fracture at hip and spine using a conventional chest X-ray, acquired during a general health checkup in post-menopausal women and geriatric patients with BMD DXA Scans of bilateral hips and spine and the calculated future risks for fractures using the online FRAX Tool for the Indian population as the standards respectively - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068307
Enrollment
400
Registered
2024-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M800- Age-related osteoporosis with current pathological fracture

Interventions

Sponsors

Diagno Intelligent Systems Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i).Post-menopausal Women ii).Geriatric patients, both female and male, aged 45 years and above iii).Known cases of osteoporosis, with and without a previous fracture

Exclusion criteria

Exclusion criteria: i).Patient, who will be suffering from the following chronic diseases will be excluded: Thyroid disease (Hypothyroidism and Hyperthyroidism), Cancer, Chronic Liver Diseases, Chronic Kidney Diseases, Chronic Heart Diseases, Organ Transplantation (Kidney, Liver, etc), Severe accident-induced fractures ii).Patient with the following: pacemaker, defibrillator, internal fixations for vertebra and clavicle fracture, bone cement, other foreign metal object iii).Patient with abnormal chest imaging, pneumonia, abnormal lung lesions iv).Patient with artifact in chest image, low-quality image

Design outcomes

Primary

MeasureTime frame
i).The accuracy of iOsteoporos Screen (an intelligent Osteoporosis Screening Software Tool) will be evaluated , when compared to BMD by DXA and the computed FRAS Score as the Standards. Its accuracy would be more than 95% ii).iOsteoporos Screen Tool can be used as an opportunistic screening tool for Osteoporosis & its risk for fracture using a chest X-ray.Timepoint: 12 weeks

Secondary

MeasureTime frame
i). Total umber of patients, aged above 45 years who are in the risk for osteoporosis & its future high risk for fracture will be predicted.Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Mrs V S Felix Enigo

Diagno Intelligent Systems Private Limited

felix.enigo@gmail.com9444662464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026