CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Zometa (zoledronic acid)drug
Likely dose
Zometa (zoledronic acid) 4 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/NCT00697619
NCT00697619Phase 2Completed

A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

Sun Yat-sen University·interventional·Posted Jun 16, 2008·Updated Mar 7, 2012

In Brief

A Phase 2 clinical trial evaluating Zometa (zoledronic acid) for Nasopharyngeal Cancer. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2008
Enrollment StartSep 1, 2005
Primary CompletionJan 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.0 years ago

Interventions

Zometa (zoledronic acid)drug

Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily