Overview

This trial is active, not recruiting.

Conditions osteoporosis, liver transplantation
Treatment zoledronate
Sponsor Medical University of Vienna
Start date April 2002
Trial size 96 participants
Trial identifier NCT00302484, LTX-BISPHO-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
first bone fracture or death within 24 months after liver transplantation
time frame:

Secondary Outcomes

Measure
bone mineral density (pre-transplant, 6 and 12 months post-transplant)
time frame:
serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
time frame:
histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
time frame:

Eligibility Criteria

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

Additional Information

Official title Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
Principal investigator Ferdinand Mühlbacher, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2006.
Information provided to ClinicalTrials.gov by Medical University of Vienna.