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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractured subjects | Post-menopausal women who have been hospitalised because of a femur fracture. |
| |
| Control subjetcs | Post-menopausal women without history of fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan at the femur | Diagnostic Test | Additional CT scan which is not part of the standard clinical path |
|
| Measure | Description | Time Frame |
|---|---|---|
| Femoral fracture event | 5 years | |
| BBCT-hip risk prediction | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| T-score | gold standard parameter for osteoporosis diagnosis | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
only for the fracturegroup:
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Resident in Emilia Romagna, Italy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Recruiting | Bologna | 40136 | Italy |
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| Label | URL |
|---|---|
| Publication about BBCT-hip methodology | View source |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D006620 | Hip Fractures |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Rizzoli Orthopaedic Institute | Recruiting | Bologna | 40136 | Italy |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |