RecruitingNCT06270758

Clinical Validation of BBCT-hip

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

300 participants

Start Date

Nov 7, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying CT scan at the femur for people with osteoporosis. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 65 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCT scan at the femur

Additional CT scan which is not part of the standard clinical path


Locations(2)

Rizzoli Orthopaedic Institute

Bologna, Italy

Rizzoli Orthopaedic Institute

Bologna, Italy

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NCT06270758


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