Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00302484

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

MedlinePlus related topics: Liver Transplantation Osteoporosis

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study

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

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

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009