CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,456 enrolled
Drug / intervention
Zoledronic Acid +1 moredrug
Likely dose
Zoledronic acid 5 mg IV infusion (in 100 mL normal saline)AI-extracted
Key inclusion· 1
  • ✓Completed 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study
Key exclusion· 5
  • ✕Poor kidney function
  • ✕Poor liver function
  • ✕Poor eye health
  • ✕Use of osteoporosis therapies other than study medication during HORIZON-PFT

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

Search/NCT00145327
NCT00145327Phase 3Completed
CompareCT.gov

A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

Novartis·interventional·Posted Sep 5, 2005·Updated Jun 28, 2011

In Brief

A Phase 3 clinical trial evaluating Zoledronic Acid and Placebo for Osteoporosis. Completed, enrolled 2,456 participants across 31 sites in 2 countries.

Detailed Summary

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesGermany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartMay 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.8 years ago

Interventions

Zoledronic Aciddrug

Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.

Placebodrug

100 mL physiologic 0.9% normal saline for intravenous infusion.