<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811873</url>
  </required_header>
  <id_info>
    <org_study_id>18-004899</org_study_id>
    <nct_id>NCT03811873</nct_id>
  </id_info>
  <brief_title>Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates</brief_title>
  <acronym>VFA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment&#xD;
      (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver&#xD;
      transplant patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 27, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Testing a single group of participants who are first time liver transplant candidates.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)</measure>
    <time_frame>24 months</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in bone mineral density by dual x-ray absorptiometry</measure>
    <time_frame>24 months</time_frame>
    <description>Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis</measure>
    <time_frame>24 months</time_frame>
    <description>Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bone turnover markers in end stage liver disease</measure>
    <time_frame>24 months</time_frame>
    <description>Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Metabolic Bone Disease</condition>
  <condition>Transplant-Related Disorder</condition>
  <condition>Secondary Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Vertebral fracture assessment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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..</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dual x-ray absorptiometry</intervention_name>
    <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.</description>
    <arm_group_label>Vertebral fracture assessment</arm_group_label>
    <other_name>DEXA</other_name>
    <other_name>Bone mineral density</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vertebral Fracture Assessment</intervention_name>
    <description>Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.</description>
    <arm_group_label>Vertebral fracture assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  First time liver transplant candidates deemed too early for liver transplant&#xD;
&#xD;
          -  24 hour urine Creatinine clearance of &gt; 40 mg/dl. However bone turnover markers (beta&#xD;
             CTx and P1NP) will be measured only in those with creatinine clearance &gt;60mg/dl&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patients with prior solid organ transplantation&#xD;
&#xD;
          -  Liver/kidney combination will be excluded&#xD;
&#xD;
          -  Patients with 24 hr. urine creatinine clearance &lt; 40mL/minute&#xD;
&#xD;
          -  Patients who have been on osteoporosis medications - Bisphosphonates [Fosamax&#xD;
             (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic&#xD;
             acid)] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the&#xD;
             past 5 years&#xD;
&#xD;
          -  Use of other systemic medications that can effect bone remodeling including sex&#xD;
             hormone replacement therapy (estrogen or testosterone), calcitonin, androgen&#xD;
             deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months&#xD;
&#xD;
          -  Underlying disease that significantly impacts bone metabolism such as primary&#xD;
             hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or&#xD;
             malignancies with skeletal metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ejigayehu G Abate, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Ejigayehu G. Abate</investigator_full_name>
    <investigator_title>Assistant Professor of medicine</investigator_title>
  </responsible_party>
  <keyword>transplant related disorders</keyword>
  <keyword>liver transplant</keyword>
  <keyword>transplant related bone disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811873
org study id: 18-004899
nct id: NCT03811873
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Testing a single group of participants who are first time liver transplant candidates.
primary purpose: Prevention
masking: None (Open Label)
measure: Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
time frame: 24 months
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)
measure: Changes in bone mineral density by dual x-ray absorptiometry
time frame: 24 months
description: Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months
measure: Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
time frame: 24 months
description: Bone strength measurements derived from finite element assessment changes from baseline to 12 months and correlation with clinical and radiographic risk of fracture
measure: Changes in bone turnover markers in end stage liver disease
time frame: 24 months
description: Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months
arm group label: Vertebral fracture assessment
arm group type: Other
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: Dual x-ray absorptiometry
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.
arm group label: Vertebral fracture assessment
other name: DEXA
other name: Bone mineral density
intervention type: Other
intervention name: Vertebral Fracture Assessment
description: Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.
arm group label: Vertebral fracture assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ejigayehu G Abate, M.D
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Ejigayehu G. Abate
investigator title: Assistant Professor of medicine
mesh term: Osteoporosis
mesh term: Bone Diseases
mesh term: Bone Diseases, Metabolic
mesh term: Spinal Fractures