Assessment of Vertebral Fracture Risk using VFA and Vertebral Strength Assessment with DXA-Finite Element Analysis in Liver Transplant Recipients in Pre-transplant Period
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-004899
NCT ID: NCT03811873
Sponsor Protocol Number: 18-004899
About this study
The purpose of this study is to evaluate the effectiveness of vertebral fracture assessment (VFA) in evaluation of asymptomatic fracture in pre-liver transplant patients as compared to the current standard of care using spine x-ray
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years old.
- First time liver transplant candidates deemed too early for liver transplant.
- 24 hour urine Creatinine clearance of > 40 mg/dl and/or eGFR > 60; 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 disase of bone, fibrous dyplasia, or malignancies with skeletal metastases.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Ejigayehu Abate, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available