Clinical Validation of BBCT-hip

Osteoporosis Clinical Trial

— ValidaBBCT-hip  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270758
• Other study ID #: 453/2023/Sper/IOR
• Status: Recruiting
• Start date: November 7, 2023
• Est. completion date: November 6, 2030

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 6, 2030
• Est. primary completion date: November 6, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Diagnostic Test:
• CT scan at the femur
Additional CT scan which is not part of the standard clinical path

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral fracture event		5 years
Primary	BBCT-hip risk prediction		5 years
Secondary	T-score	gold standard parameter for osteoporosis diagnosis	5 years

External Links

•   Publication about BBCT-hip methodology