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

NCT00114556 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2006-05-09

No results posted yet for this study

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.

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.

Conditions

Interventions

DRUG

zoledronic acid

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Royal Prince Alfred Hospital, Sydney, Australia

    lead OTHER

Principal Investigators

  • Geoffrey McCaughan, PhD, MB BS · Royal Prince Alfred Hospital, Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Completion
2004-08-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114556 on ClinicalTrials.gov