This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant 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
Enrollment
13
6mg iv on days 1-3
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Pain and analgesic consumption
Time frame: Days 1, 7 and 14
AEs and laboratory parameters
Time frame: Days 1, 4 and 7
Serum creatinine
Time frame: Days 1, 4 and 7
Karnofsky index
Time frame: Day 7
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Izmir, Turkey (Türkiye)
Unnamed facility
Shhiye, Ankara, Turkey (Türkiye)