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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 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%
研究概览
简要总结
1) 1. “iOsteoporos Screen†is a novel Artificial Intelligence (AI) enabled Screening Software Tool that assess the conventional chest X-ray (in DICOM/ JEPG format) of a patient and gives an automated computerised test report whether the patient is osteoporotic or normal.
2. It is a retrospective type of Observational Study that uses the already taken chest X-ray for screening Osteoporosis. Also, it is non-invasive and there is no intervention involved in this study.
3. We have obtained Institutional Ethical Committee Approval for this study.
4. This study uses OLD DATA from the medical records.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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%
时间窗: 12 weeks
ii).iOsteoporos Screen Tool can be used as an opportunistic screening tool for Osteoporosis & its risk for fracture using a chest X-ray.
时间窗: 12 weeks
次要结局
- 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.(12 weeks)
研究者
Dr Roshini Maria Abraham
Chettinad Hospital and Research Institute