Metabolic Bone Disease, Transplant-Related Disorder, Secondary Osteoporosis
Conditions
Keywords
transplant related disorders, liver transplant, transplant related bone disease
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.
Interventions
DIAGNOSTIC_TESTDual x-ray absorptiometry
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.
Lumbar/thoracic spine x-ray and labs assessed for bone turnover markers.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Testing a single group of participants who are first time liver transplant candidates.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone mineral density by dual x-ray absorptiometry | 24 months | Bone mineral density changes seen in end stage liver disease in (grams/cm2) at baseline and 12 months |
| Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis | 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 |
| Changes in bone turnover markers in end stage liver disease | 24 months | Bone turnover markers (Beta CTX, P1NP) percent changes from baseline to 12 months |
Countries
United States
Outcome results
None listed