NCT00051636

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Randomized, Double-blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observational Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Conditions

• Paget's Disease of Bone

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.
DRUG	Risedronate	Oral risedronate 30 mg capsules.
DRUG	Placebo to Risedronate	Oral placebo of risedronate capsules.
DRUG	Placebo to Zoledronic Acid	5 mL of sterile water one dose intravenous infusion.
DIETARY_SUPPLEMENT	Calcium and Vitamin D	Calcium and vitamin D supplements were supplied.

Timeline

• Start date: 2001-01-01
• Primary completion: 2004-03-01
• Completion: 2011-04-01
• First posted: 2003-01-15
• Last updated: 2012-05-15
• Results posted: 2012-05-07

Locations

34 sites across 6 countries: United States, Australia, Canada, New Zealand, Spain, United Kingdom