Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates (VFA)

Mayo Clinic

Status: Completed

Conditions: Metabolic Bone Disease; Transplant-Related Disorder; Secondary Osteoporosis

Treatments: Other: Vertebral Fracture Assessment; Diagnostic Test: Dual x-ray absorptiometry

Study type: Interventional

Funder types: Other

Identifiers

NCT03811873

18-004899

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Vertebral fracture assessment

Other group

Description:

Study participants undergoing evaluation for liver transplant and deemed to early for transplant will receive standard of care bone mineral density and vertebral fracture assessment..

Treatment:

Other: Vertebral Fracture Assessment

Diagnostic Test: Dual x-ray absorptiometry