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The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertebral fracture assessment | Other | Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual x-ray absorptiometry | Diagnostic Test | DEXA is a means of measuring bone mineral density (BMD) using spectral imaging. Two X-ray beams, with different energy levels, are aimed at the bones. Soft tissue absorption is subtracted out, then the bone mineral density (BMD) can be determined from the absorption of each beam by bone. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA) | Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone mineral density by dual x-ray absorptiometry | Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months | 24 months |
| Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis |
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Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ejigayehu G Abate, M.D | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| D015519 | Bone Density |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Testing a single group of participants who are first time liver transplant candidates.
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|
|
| Vertebral Fracture Assessment | Other | Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers. |
|
Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture |
| 24 months |
| Changes in bone turnover markers in end stage liver disease | Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months | 24 months |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |