Liver Transplantation, Osteoporosis
Conditions
Brief summary
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.
Interventions
DRUGZoledronate
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| first bone fracture or death within 24 months after liver transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria
Outcome results
None listed