Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates (VFA)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Bone Disease; Transplant-Related Disorder; Secondary Osteoporosis
• Intervention / Treatment: Diagnostic test: Dual x-ray absorptiometry; Other: Vertebral Fracture Assessment

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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..

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 Names: DEXA; Bone mineral density; Other: Vertebral Fracture Assessment; Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: liver transplant; transplant related disorders; transplant related bone disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Injuries; Back Injuries; Osteoporosis; Bone Diseases; Bone Diseases, Metabolic; Spinal Fractures
• Other Study ID Numbers: 18-004899

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No