Clinical Validation of BBCT-hip
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT scan at the femur.
- Who it may be relevant to
- Registry conditions: Osteoporosis. Basic parameters: 65 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Overview
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.
Interventions
- Diagnostic test CT scan at the femur
Additional CT scan which is not part of the standard clinical path
Primary outcome measures
- Femoral fracture event [Time frame: 5 years]
- BBCT-hip risk prediction [Time frame: 5 years]
Secondary outcome measures (1)
- T-score [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- caucasic post-menopausal women resident in Emilia-Romagna
- menopause (>= 45 years)
Exclusion criteria
- tumours
- not free living
- Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
- Long-term continuous therapy (>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
- Previous femur fractures
- Presence of hip/knee prosthesis
only for the fracturegroup:
- presence of fixation devices after the fracture
- femur fracture due to high energy trauma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 2 centers
- Rizzoli Orthopaedic Institute — Bologna
- Rizzoli Orthopaedic Institute — Bologna
Identifiers
NCT: NCT06270758 · 453/2023/Sper/IOR