Status:
COMPLETED
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
Lead Sponsor:
Mayo Clinic
Conditions:
Metabolic Bone Disease
Transplant-Related Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03811873
Start Date
February 18 2019
End Date
August 30 2022
Last Update
May 6 2023
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224