Clinical Validation of BBCT-hip
Recruiting · NCT06270758 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- nly for the fracturegroup:
- presence of fixation devices after the fracture
- femur fracture due to high energy trauma
Where it is running
2 locations listed.
- Rizzoli Orthopaedic Institute - Bologna, Italy
- Rizzoli Orthopaedic Institute - Bologna, Italy