Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
This trial is active, not recruiting.
|Conditions||osteoporosis, liver transplantation|
|Sponsor||Medical University of Vienna|
|Start date||April 2002|
|Trial size||96 participants|
|Trial identifier||NCT00302484, LTX-BISPHO-01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
first bone fracture or death within 24 months after liver transplantation
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)
Male or female participants at least 18 years old.
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
|Official title||Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study|
|Principal investigator||Ferdinand Mühlbacher, M.D.|
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