NCT00099177

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

A Randomized, 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: 96 (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 a regimen of intravenous (iv) and oral 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 followed by Bondronat 5Omg po daily from day 22 to week 24) 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 50mg po from day 22 to week 24
DRUG	zoledronic acid	4mg iv on day 1, and every 3-4 weeks

Timeline

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

Locations

41 sites across 16 countries: United States, Argentina, Australia, Chile, Germany, Greece, Guatemala, Hungary, Italy, Mexico, Panama, Poland, Puerto Rico, Russia, Switzerland, United Kingdom