- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00302484
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
July 25, 2006 updated by: Medical University of Vienna
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, A-1090
- Medical University of Vienna, Department of Surgery, Division of Transplantation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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first bone fracture or death within 24 months after liver transplantation
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Secondary Outcome Measures
Outcome Measure |
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bone mineral density (pre-transplant, 6 and 12 months post-transplant)
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serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
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histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ferdinand Mühlbacher, M.D., Medical University of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Registration Dates
First Submitted
March 13, 2006
First Submitted That Met QC Criteria
March 13, 2006
First Posted (ESTIMATE)
March 14, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
July 26, 2006
Last Update Submitted That Met QC Criteria
July 25, 2006
Last Verified
January 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTX-BISPHO-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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