NCT06270758Recruiting
Clinical Validation of BBCT-hip
Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 14 Feb 2024
- Start date
- 7 Nov 2023
- Primary completion date
- 6 Nov 2030
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Diseases
- Osteoporosis
- NCT number
- NCT06270758
What you commit to
- Study type: Observational
- Planned participants: 300
- From 7 Nov 2023 to the primary completion date, 6 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term continuous therapy (\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors
- Previous femur fractures
Other illness
- Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases
Other
- tumours
- not free living
- Presence of hip/knee prosthesis
- only for the fracturegroup:
- presence of fixation devices after the fracture
- femur fracture due to high energy trauma
Who the study is looking for
- caucasic post-menopausal women resident in Emilia-Romagna
- menopause (\>= 45 years)
Age in the registry: 65 years to 85 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rizzoli Orthopaedic Institute Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.