Assessing fracture risk in post-menopausal women using BBCT-hip
Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction
This study is testing a new method called BBCT-hip to see if it can accurately predict hip fracture risk in post-menopausal women based on their height, weight, and CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | Female |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06270758 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the accuracy of the BBCT-hip methodology, which predicts the risk of hip fractures based on individual height, weight, and CT scans of the femur. It involves enrolling 150 subjects who have experienced a fracture and 150 control subjects without fractures. Both groups will undergo CT scans, and the predictive accuracy of BBCT-hip will be assessed through a transversal study and a longitudinal follow-up of the control group. The goal is to determine how well BBCT-hip can differentiate between those at risk of fractures and those who are not.
Who should consider this trial
Good fit: Ideal candidates are Caucasian post-menopausal women aged 45 and older residing in Emilia-Romagna.
Not a fit: Patients with chronic diseases causing severe organ failure, previous femur fractures, or those on long-term corticosteroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fracture risk assessment and prevention strategies for post-menopausal women with osteoporosis.
How similar studies have performed: While the approach of using in silico methods for fracture prediction is innovative, similar studies have shown promise in fracture risk assessment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna and 1 other locations
- Rizzoli Orthopaedic Institute — Bologna, Italy (Recruiting)
- Rizzoli Orthopaedic Institute — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.