CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Zoledronic acid +3 moredrug
Likely dose
Zoledronic acid 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00297830
NCT00297830Phase 3Completed
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Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

Columbia University·interventional·Posted Mar 1, 2006·Updated Aug 16, 2018

In Brief

A Phase 3 clinical trial evaluating Zoledronic acid, Alendronate, and 2 other interventions for Heart Transplantation and 2 related conditions. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplantation, Liver Transplantation, Bone Resorption
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2006
Enrollment StartNov 1, 2005
Primary CompletionApr 1, 2010
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.3 years ago

Interventions

Zoledronic aciddrug

Drug is administered through 5 mg intravenous infusion over 20 minutes

Alendronatedrug

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

Placebo Zoledronic Acidother

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

Placebo Alendronateother

Placebo alendronate 70 mg once weekly