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Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00302484
Recruitment Status : Unknown
Verified January 2006 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : March 14, 2006
Last Update Posted : July 26, 2006
Sponsor:
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment
Osteoporosis Liver Transplantation Drug: Zoledronate

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
Study Start Date : April 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. first bone fracture or death within 24 months after liver transplantation

Secondary Outcome Measures :
  1. bone mineral density (pre-transplant, 6 and 12 months post-transplant)
  2. serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
  3. histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00302484     History of Changes
Other Study ID Numbers: LTX-BISPHO-01
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: July 26, 2006
Last Verified: January 2006

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