The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT00114556
First received: June 15, 2005
Last updated: May 8, 2006
Last verified: December 2004
  Purpose

Following liver transplantation, rapid bone loss occurs, particularly within the first 6 months post-transplant. This may be associated with fractures, most notable vertebral. The ability to assess osteoporosis therapies in this system may provide useful information for osteoporosis management in general.

Hypotheses:

  1. That treatment with the bisphosphonate, zoledronate, at the time of liver transplantation and at 1 month post-transplantation will prevent the early transplant-related bone loss (measured by bone densitometry and biochemical bone markers at 3 months) seen in patients who are not treated with a bisphosphonate
  2. That continuing treatment with zoledronate at 3 monthly intervals for a total duration of 12 months will result in further improvements in bone density beyond that seen at 3 months
  3. That calcium and vitamin D (vit D) supplementation of liver transplant patients does not prevent marked bone loss following transplantation.

Condition Intervention Phase
Osteoporosis
Liver Transplantation
Fractures
Drug: zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect Of The Bisphosphonate, Zoledronic Acid, On Bone Density In Liver Transplant Patients – A Prospective, Randomised, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • bone density

Secondary Outcome Measures:
  • bone turnover markers

Estimated Enrollment: 100
Study Start Date: February 2000
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 17 years of age

Exclusion Criteria:

  • Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism
  • Hypocalcemia
  • Renal impairment (creatinine >1.5x ULN)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00114556

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Novartis
Investigators
Principal Investigator: Geoffrey McCaughan, PhD, MB BS Royal Prince Alfred Hospital, Sydney, Australia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00114556     History of Changes
Other Study ID Numbers: CZOL446 AU02
Study First Received: June 15, 2005
Last Updated: May 8, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Royal Prince Alfred Hospital, Sydney, Australia:
osteoporosis
liver transplantation

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 September 18, 2014