Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates



Status:Not yet recruiting
Conditions:Osteoporosis, Gastrointestinal
Therapuetic Areas:Gastroenterology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:January 28, 2019
End Date:October 2021

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

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.


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
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