| NCT ID | NCT06270758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteoporosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2030-11-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-11-07 with a primary completion date of 2030-11-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06270758 clinical trial?
This trial is open to female participants only, aged 65 Years or older, up to 85 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06270758 currently recruiting?
Yes, NCT06270758 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT06270758 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy.
Who is sponsoring the NCT06270758 clinical trial?
NCT06270758 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 300 participants.