NCT03811873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

January 4, 2019

Last Update Submit

May 4, 2023

Conditions

Metabolic Bone DiseaseTransplant-Related DisorderSecondary Osteoporosis

Keywords

transplant related disordersliver transplanttransplant related bone disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in bone mineral density by dual x-ray absorptiometry

    24 months

  • Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis

    24 months

  • Changes in bone turnover markers in end stage liver disease

    24 months

Study Arms (1)

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..

Diagnostic Test: Dual x-ray absorptiometryOther: Vertebral Fracture Assessment

Interventions

Dual x-ray absorptiometryDIAGNOSTIC_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.

Also known as: DEXA, Bone mineral density
Vertebral fracture assessment
Vertebral Fracture AssessmentOTHER

Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.

Vertebral fracture assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First time liver transplant candidates deemed too early for liver transplant
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Absorptiometry, PhotonBone Density

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ejigayehu G Abate, M.D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Testing a single group of participants who are first time liver transplant candidates.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of medicine

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 22, 2019

Study Start

February 18, 2019

Primary Completion

July 27, 2022

Study Completion

August 30, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

US(1)