Clinical Validation of BBCT-hip

Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06270758

Acronym

ValidaBBCT-hip

Enrollment

300

Registered

2024-02-21

Start date

2023-11-07

Completion date

2030-11-06

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

hip fracture, fracture prediction, finite element, in silico, osteoporotic fracture

Brief 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.

Interventions

DIAGNOSTIC_TESTCT scan at the femur

Additional CT scan which is not part of the standard clinical path

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Femoral fracture event	5 years
BBCT-hip risk prediction	5 years

Secondary

Measure	Time frame	Description
T-score	5 years	gold standard parameter for osteoporosis diagnosis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026