This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Participants will receive ibandronate, 6 mg via IV infusion, every 3 weeks for up to 9 cycles. The infusion interval will be either 15 or 60 minutes depending upon treatment group assignment every 3 weeks (9 treatment cycles in total).
Unnamed facility
Amboise, France
Unnamed facility
Angers, France
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
Time frame: 28 days after last infusion (approximately 2 years)
Number of Participants with Bone Pain According to Visual Analog Scale (VAS)
Time frame: Every 3 weeks up to approximately 6 months
Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)
Time frame: Up to approximately 7 months
Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder
Time frame: Up to approximately 7 months
Karnofsky Index score
Time frame: Every 3 weeks up to approximately 6 months
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Unnamed facility
Bayonne, France
Unnamed facility
Besançon, France
Unnamed facility
Boulogne-Billancourt, France
Unnamed facility
Brest, France
Unnamed facility
Chambéry, France
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Évreux, France
Unnamed facility
Gap, France
...and 20 more locations