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Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

NCT00297830 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-08-16

Study results available
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Summary

The purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are expected to be very effective, but it is not known which one will work best.

Conditions

  • Heart Transplantation
  • Liver Transplantation
  • Bone Resorption

Interventions

DRUG

Zoledronic acid

Drug is administered through 5 mg intravenous infusion over 20 minutes

DRUG

Alendronate

Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal

OTHER

Placebo Zoledronic Acid

Infusion of placebo zoledronic acid during the first 5 weeks after transplantation

OTHER

Placebo Alendronate

Placebo alendronate 70 mg once weekly

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Shane, M.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-04-30
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00297830 on ClinicalTrials.gov