Clinical Validation of BBCT-hip - Trial NCT06270758
Access comprehensive clinical trial information for NCT06270758 through Pure Global AI's free database. This phase not specified trial is sponsored by Istituto Ortopedico Rizzoli and is currently Recruiting. The study focuses on Osteoporosis. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Istituto Ortopedico Rizzoli
Timeline & Enrollment
N/A
Nov 07, 2023
Nov 06, 2030
Primary Outcome
Femoral fracture event,BBCT-hip risk prediction
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06270758
Non-Device Trial