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Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Medical University of Vienna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00302484
First received: March 13, 2006
Last updated: July 25, 2006
Last verified: January 2006
History of Changes
  Purpose

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.


Condition Intervention
Osteoporosis
Liver Transplantation
 Drug: Zoledronate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

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)

Estimated Enrollment: 96
Study Start Date: April 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302484

Locations
Austria
Medical University of Vienna, Department of Surgery, Division of Transplantation
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ferdinand Mühlbacher, M.D. Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00302484     History of Changes
Other Study ID Numbers: LTX-BISPHO-01
Study First Received: March 13, 2006
Last Updated: July 25, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
 Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013