Clinical Validation of BBCT-hip

NCT06270758 | Recruiting

• 1 other identifier: 453/2023/Sper/IOR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Femoral fracture event

  5 years

• BBCT-hip risk prediction

  5 years

Secondary Outcomes (1)

• T-score

  5 years

Study Arms (2)

Fractured subjects

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

Diagnostic Test: CT scan at the femur

Control subjetcs

Post-menopausal women without history of fracture

Diagnostic Test: CT scan at the femur

Interventions

CT scan at the femur DIAGNOSTIC_TEST

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

Control subjetcs; Fractured subjects

Eligibility Criteria

• Age: 65 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Resident in Emilia Romagna, Italy

You may qualify if:

• caucasic post-menopausal women resident in Emilia-Romagna
• menopause (\>= 45 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (2)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

RECRUITING

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

RECRUITING

Related Links

• Publication about BBCT-hip methodology

MeSH Terms

Conditions

Osteoporosis; Hip Fractures; Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: November 7, 2023
• Primary Completion (Estimated): November 6, 2030
• Study Completion (Estimated): November 6, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (2)