Status:
TERMINATED
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Pain
Bone Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 randomiz...
Eligibility Criteria
Inclusion
- patients with malignant bone disease;
- patients with moderate to severe pain.
Exclusion
- patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;
- patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
- untreated esophagitis or gastric ulcers;
- recent or pre-scheduled radiotherapy to bone;
- patients who are pregnant or breast-feeding.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00099203
Start Date
July 1 2005
End Date
December 1 2007
Last Update
August 16 2017
Active Locations (72)
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1
Birmingham, Alabama, United States, 35205
2
Sedona, Arizona, United States, 86336
3
Ocoee, Florida, United States, 34761
4
Macon, Georgia, United States, 31201