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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
6mg iv on days 1-3, and 50mg po from day 22 to week 24
4mg iv on day 1, and every 3-4 weeks
Unnamed facility
Miami, Florida, United States
Unnamed facility
Macon, Georgia, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Bahía Blanca, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Rosario, Argentina
Unnamed facility
Santa Fe, Argentina
Unnamed facility
Adelaide, Australia
Unnamed facility
Brisbane, Australia
...and 31 more locations
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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