Clinical Validation of BBCT-hip (ValidaBBCT-hip)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Osteoporosis

Treatments: Diagnostic Test: CT scan at the femur

Study type: Observational

Funder types: Other

Identifiers

NCT06270758

453/2023/Sper/IOR

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Fractured subjects

Description:

Post-menopausal women who have been hospitalised because of a femur fracture.

Treatment:

Diagnostic Test: CT scan at the femur

Control subjetcs

Description:

Post-menopausal women without history of fracture

Treatment:

Diagnostic Test: CT scan at the femur