This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
6mg iv on days 1-3
Unnamed facility
Alexandroupoli, Greece
Unnamed facility
Athens, Greece
Unnamed facility
Haidari, Greece
Unnamed facility
Pátrai, Greece
Unnamed facility
Piraeus, Greece
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Time frame: Days 5 - 7
Mean worst pain score over first 7 days
Time frame: Day 7
Analgesic consumption
Time frame: Day 7
Karnofsky index
Time frame: Day 7
AEs, laboratory parameters
Time frame: Throughout study
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Unnamed facility
Thessaloniki, Greece