Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

Medical University of Vienna96 enrolled

Overview

Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis Liver Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * primary liver transplantation * retransplantation within two weeks * written informed consent * Age ≥ 18 years Exclusion Criteria: * chronic kidney disease: * Creatinine Clearance \< 35 ml/min or Serum Creatinine \> 2,5 mg/dl * known hypersensitivity to Zoledronate, or any of the recipients of the drug * bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation

Outcomes

Primary Outcomes

first bone fracture or death within 24 months after liver transplantation

Secondary Outcomes

bone mineral density (pre-transplant, 6 and 12 months post-transplant)

serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)

histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)