Status:

COMPLETED

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

Lead Sponsor:

Royal Prince Alfred Hospital, Sydney, Australia

Collaborating Sponsors:

Novartis

Conditions:

Osteoporosis

Liver Transplantation

Eligibility:

All Genders

17-70 years

Phase:

PHASE4

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 os...

Detailed Description

This study is a prospective, randomised, double-blind, placebo-controlled clinical trial in liver transplant patients comparing therapy with the bisphosphonate, zoledronate, to patients who do not rec...

Eligibility Criteria

Inclusion

  • Greater than 17 years of age

Exclusion

  • Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism
  • Hypocalcemia
  • Renal impairment (creatinine \>1.5x ULN)

Key Trial Info

Start Date :

February 1 2000

Trial Type :

INTERVENTIONAL

End Date :

August 1 2004

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00114556

Start Date

February 1 2000

End Date

August 1 2004

Last Update

May 9 2006

Active Locations (1)

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1

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia, 2050