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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
History of Changes
  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:

U.S. FDA Resources

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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 23, 2016