Back to resultsUse of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
Primary Purpose
Osteoporosis, Liver Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Zoledronate
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna, Department of Surgery, Division of Transplantation
Outcomes
Primary Outcome Measures
first bone fracture or death within 24 months after liver transplantation
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00302484
First Posted
March 13, 2006
Last Updated
July 25, 2006
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00302484
Brief Title
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
Official Title
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Liver Transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zoledronate
Primary Outcome Measure Information:
Title
first bone fracture or death within 24 months after liver transplantation
Secondary Outcome Measure Information:
Title
bone mineral density (pre-transplant, 6 and 12 months post-transplant)
Title
serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
Title
histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdinand Mühlbacher, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Surgery, Division of Transplantation
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
We'll reach out to this number within 24 hrs