NCT00099203

A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Conditions

• Pain
• Bone Neoplasm
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	ibandronate [Bondronat]	6mg iv on days 1-3, and every 3-4 weeks
DRUG	zoledronic acid	4mg iv on day 1 and every 3-4 weeks

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2004-12-10
• Last updated: 2017-08-16

Locations

72 sites across 18 countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany, Guatemala, Hungary, Italy, Mexico, Panama, Poland, Puerto Rico, Russia, Switzerland, United Kingdom