Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates (NCT03811873) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
United States52 participantsStarted 2019-02-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)