NCT06270758

Clinical Validation of BBCT-hip

Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Istituto Ortopedico Rizzoli·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Osteoporosis
Drug/Device/Intervention
CT scan at the femur
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Istituto Ortopedico Rizzoli
Location
Bologna,Bologna, Italy
Timeline & enrollment
Phase
N/A
Start date
Nov 07, 2023
End date
Nov 06, 2030
Enrollment
300 participants
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
Osteoporosis, unspecifiedOther osteoporosisIdiopathic osteoporosisOsteoporosis in diseases classified elsewherePostmenopausal osteoporosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06270758
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.