Back to resultsAssessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates (VFA)
Primary Purpose
Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual x-ray absorptiometry
Vertebral Fracture Assessment
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Bone Disease focused on measuring transplant related disorders, liver transplant, transplant related bone disease
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vertebral fracture assessment
Arm Description
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..
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Changes in bone turnover markers in end stage liver disease
Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03811873
Brief Title
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
Acronym
VFA
Official Title
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
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis
Keywords
transplant related disorders, liver transplant, transplant related bone disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Testing a single group of participants who are first time liver transplant candidates.
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vertebral fracture assessment
Arm Type
Other
Arm Description
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..
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual x-ray absorptiometry
Other Intervention Name(s)
DEXA, Bone mineral density
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vertebral Fracture Assessment
Intervention Description
Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.
Primary Outcome Measure Information:
Title
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
Description
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging (VFA) as compared to standard of care ( Spine X-ray)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Changes in bone mineral density by dual x-ray absorptiometry
Description
Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months
Time Frame
24 months
Title
Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
Description
Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture
Time Frame
24 months
Title
Changes in bone turnover markers in end stage liver disease
Description
Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ejigayehu G Abate, M.D
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
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