Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period

Conditions
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Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis

Intervention / Treatment
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* Diagnostic Test: Dual x-ray absorptiometry
* Other: Vertebral Fracture Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria First time liver transplant candidates deemed too early for liver transplant 24 hour urine Creatinine clearance of > 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance >60mg/dl Exclusion criteria Patients with prior solid organ transplantation Liver/kidney combination will be excluded Patients with 24 hr. urine creatinine clearance < 40mL/minute Patients who have been on osteoporosis medications - Bisphosphonates [Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Testing a single group of participants who are first time liver transplant candidates.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vertebral fracture assessment<br>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.. | Diagnostic Test: Dual x-ray absorptiometry<br>* 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.<br>* Other names: Bone mineral density;Other: Vertebral Fracture Assessment<br>* Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant related disorders, liver transplant, transplant related bone disease