NCT06270758

Clinical Validation of BBCT-hip

Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: Female
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT scan at the femur	Additional CT scan which is not part of the standard clinical path

Timeline

• Start date: 2023-11-07
• Primary completion: 2030-11-06
• Completion: 2030-11-06
• First posted: 2024-02-21
• Last updated: 2025-02-17

Locations

2 sites across 1 country: Italy