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

Not Applicable

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

Registration Number: CTRI/2024/06/068307

Lead Sponsor: Diagno Intelligent Systems Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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% <br/ ><br>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 Outcome Measures

Name	Time	Method
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