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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: t
View:

• caucasic post-menopausal women resident in Emilia-Romagna

• menopause (\>= 45 years)

Locations
Other Locations
Italy
Rizzoli Orthopaedic Institute
RECRUITING
Bologna
Rizzoli Orthopaedic Institute
RECRUITING
Bologna
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2030-11-06
Participants
Target number of participants: 300
Treatments
Fractured subjects
Post-menopausal women who have been hospitalised because of a femur fracture.
Control subjetcs
Post-menopausal women without history of fracture
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov