Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
Not Applicable
- Conditions
- OsteoporosisLiver Transplantation
- Registration Number
- NCT00302484
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method first bone fracture or death within 24 months after liver transplantation
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Medical University of Vienna, Department of Surgery, Division of Transplantation
🇦🇹Vienna, Austria