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OpenTrials
Completed

NCT Number: NCT03811873

Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates

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.

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Key information

Conditions

Metabolic Bone Disease Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Secondary Osteoporosis Transplant-Related Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual x-ray absorptiometry

Diagnostic 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.

Other names: DEXA, Bone mineral density

Vertebral Fracture Assessment

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: VFA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2019
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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