Clinical Validation of BBCT-hip

Recruiting

• Conditions: Osteoporosis
• Interventions: Diagnostic Test: CT scan at the femur

• Registration Number: NCT06270758
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-07
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2030-11-06
• Study Completion: 2030-11-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fractured subjects	CT scan at the femur	Post-menopausal women who have been hospitalised because of a femur fracture.
Control subjetcs	CT scan at the femur	Post-menopausal women without history of fracture

Primary Outcome Measures

Name	Time	Method
Femoral fracture event	5 years
BBCT-hip risk prediction	5 years

Secondary Outcome Measures

Name	Time	Method
T-score	5 years	gold standard parameter for osteoporosis diagnosis

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy