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

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ClinicalTrials.gov Identifier: NCT00114556
Recruitment Status : Completed
First Posted : June 16, 2005
Last Update Posted : May 9, 2006
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia

Brief Summary:

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.


  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 or disease Intervention/treatment Phase
Osteoporosis Liver Transplantation Fractures Drug: zoledronic acid Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : February 2000
Estimated Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. bone density

Secondary Outcome Measures :
  1. bone turnover markers

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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): NCT00114556

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

ClinicalTrials.gov Identifier: NCT00114556     History of Changes
Other Study ID Numbers: CZOL446 AU02
First Posted: June 16, 2005    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: December 2004

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

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