A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer

Conditions
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Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention / Treatment
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* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures Metastatic breast cancer with at least one bone metastasis Karnofsky index >/= 60 Life expectancy >/= 6 months Estimated creatinine clearance (Cockcroft and Gault formula) >/= 30 milliliters per minute (mL/min) Exclusion Criteria: Pregnancy or breast feeding participant Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments Uncontrolled brain metastasis Severe or concomitant infection Known medical history of systemic disease with renal lesion Rapidly progressing renal failure at inclusion Uncontrolled cardiac disorder Hypercalcaemia (> 2.7 millimoles per liter [mmol/L]), hypocalcaemia (< 2 mmol/L) Participant receiving nephrotoxic chemotherapy Participant eligible for haematopoietic stem cell transplantation at inclusion time Bisphosphonate therapy in the 3 weeks before randomization Known hypersensitivity to ibandronate or other bisphosphonates

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate 15-Minute Infusion<br>Participants will receive ibandronate IV infusions over a 15-minute interval. | Drug: Ibandronate<br>* 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).<br>* Other names: Bondronat;|
| Active Comparator: Ibandronate 60-Minute Infusion<br>Participants will receive ibandronate IV infusions over a 60-minute interval. | Drug: Ibandronate<br>* 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).<br>* Other names: Bondronat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula |  | 28 days after last infusion (approximately 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Bone Pain According to Visual Analog Scale (VAS) |  | 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) |  | Up to approximately 7 months | 
| Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder |  | Up to approximately 7 months | 
| Karnofsky Index score |  | Every 3 weeks up to approximately 6 months |