Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

Overview

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.

Full Title of Study: “Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 27, 2022

Interventions

  • Diagnostic Test: Dual x-ray absorptiometry
    • 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.
  • Other: Vertebral Fracture Assessment
    • Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

Arms, Groups and Cohorts

  • Other: Vertebral fracture assessment
    • 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..

Clinical Trial Outcome Measures

Primary Measures

  • Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
    • Time Frame: 24 months
    • Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray)

Secondary Measures

  • Changes in bone mineral density by dual x-ray absorptiometry
    • Time Frame: 24 months
    • Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months
  • Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
    • Time Frame: 24 months
    • Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture
  • Changes in bone turnover markers in end stage liver disease
    • Time Frame: 24 months
    • Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ejigayehu G. Abate, Assistant Professor of medicine – Mayo Clinic
  • Overall Official(s)
    • Ejigayehu G Abate, M.D, Principal Investigator, Mayo Clinic

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