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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
6mg iv on days 1-3, and every 3-4 weeks
4mg iv on day 1 and every 3-4 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Sedona, Arizona, United States
Unnamed facility
Ocoee, Florida, United States
Unnamed facility
Macon, Georgia, United States
Unnamed facility
Galesburg, Illinois, United States
Unnamed facility
Pain, as measured by Brief Pain Inventory and analgesic use
Time frame: Week 24
Performance score and QoL measures
Time frame: Week 24
AEs and laboratory parameters
Time frame: Throughout study
Opioid side effects
Time frame: Throughout study
Skeletal-related events
Time frame: Throughout study
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Indianapolis, Indiana, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
Henderson, Nevada, United States
Unnamed facility
Reno, Nevada, United States
Unnamed facility
Albany, New York, United States
...and 62 more locations