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

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ClinicalTrials.gov Identifier: NCT03811873
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ejigayehu G. Abate, Mayo Clinic

Brief Summary:
The Investigators hypothesize that VFA+ DXA is as effective in evaluation of asymptotic vertebral fractures compared to the current gold standard of spine x-ray. In addition, bone turnover markers in transplant patients are unknown. The investigators want to investigate bone turnover markers (Beta CTX and P1NP) as markers of bone health in patients listed for liver transplant.

Condition or disease Intervention/treatment Phase
Metabolic Bone Disease Transplant-Related Disorder Secondary Osteoporosis Radiation: Thoracic spine X-Ray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Testing a single group of participants who are first time liver transplant candidates.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Intervention
Single-Arm trial
Radiation: Thoracic spine X-Ray
All participants will receive above interventions, in addition to their standard of care. Additionally, 15 patients will undergo CT scan of the lumbar spine at baseline and 1 year follow.
Other Names:
  • Lumbar Spine X-Ray
  • Bone Mineral Density
  • Vertebral Fracture Assessment
  • Beta CTx
  • P1NP




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811873


Contacts
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Contact: Satya Dhandapani, B.Tech, M.H.A 9049533421 dhandapani.satya@mayo.edu
Contact: Kendra J Brown, MPH, CCRP (904) 953 36131 Brown.Kendra@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: satya dhandapani, B Tech, MHA    904-953-3421    dhandapani.satya@mayo.edu   
Contact: Kendra J Brown, MPH, CCRP    9049536131    Brown.Kendra@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ejigayehu G Abate Mayo Clinic

Additional Information:
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Responsible Party: Ejigayehu G. Abate, Assistant Professor of medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03811873     History of Changes
Other Study ID Numbers: 18-004899
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Ejigayehu G. Abate, Mayo Clinic:
transplant related disorders
liver transplant
transplant related bone disease

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases
Spinal Fractures
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone