NCT00145327

Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,456 (actual)
• Sponsor: Novartis · Industry
• Sex: Female
• Age: 68 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
DRUG	Placebo	100 mL physiologic 0.9% normal saline for intravenous infusion.

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2005-09-05
• Last updated: 2011-06-28
• Results posted: 2011-04-20

Locations

31 sites across 2 countries: United States, Germany