NCT06110442

Opportunistic Fragility Fracture Risk Estimates From Radiographs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 497 (actual)
• Sponsor: University of Exeter · Academic / Other
• Sex: All
• Age: 20 Years – 120 Years
• Healthy volunteers: Accepted

Summary

The proposed study will predict a patients' risk of having osteoporosis by using a combination of the IBEX BH (Bone Health) software outputs and other clinical risk factors such as age, gender, medical history and lifestyle. A comparison will be made between the IBEX BH prediction and the one calculated in current clinical practice using a tool called FRAX (Fracture Risk Assessment Tool) which combines clinical risk factors with results from a Dual Energy X-ray Absorptiometry (DXA) assessment. The study involves conducting these assessments on several new anatomies including Knee, Ankle and Pelvis, to extend the market reach and clinical utility of IBEX BH. The expected outcome of the study is that the IBEX BH will offer better decision support to clinicians in terms of referral on for a DXA scan or osteoporosis investigations than available today.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DEVICE	IbexBH Software	A software application applied to radiographs

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-10-31
• Last updated: 2025-01-20

Locations

1 site across 1 country: United Kingdom