Randomized Trial of AI-Guided Diagnosis Using VeriOsteo OP for High-Risk Adults Aged 40 to 80 With Osteoporosis

What this Trial Is About

This research focuses on adults aged 40 to 80 years who are at high risk for osteoporosis. It aims to evaluate the clinical effectiveness and economic impact of an artificial intelligence AI-guided diagnosis system called VeriOsteo OP. The goal is to support reimbursement decisions within the national health insurance system by providing scientific evidence on the value of AI-based smart medical devices for early osteoporosis screening and management. Participants are randomly assigned in a 21 ratio to either receive the AI-guided diagnosis using VeriOsteo OP or the standard routine diagnosis for osteoporosis. Those in the AI group undergo the AI assessment followed by confirmation with a DXA scan, which is the gold standard for bone mineral density BMD evaluation. The study is conducted across multiple medical centers and includes a follow-up period averaging 18 months to assess diagnostic consistency and clinical outcomes. During the study, participants will have regular follow-up visits every six months up to 18 months to monitor bone mineral density improvements, incidence of bone fractures, and all-cause mortality. Data collection includes diagnostic reports, clinical evaluations, and economic assessments to measure healthcare cost reduction and clinical benefits. The study also ensures data privacy and security throughout the research process, with the ultimate aim of guiding national healthcare policy and advancing AI-driven medical technology adoption.

Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial