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

Phase 3

Completed

• Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
• Interventions: Drug: Ibandronate

• Registration Number: NCT02716792
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2016-03
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-18
• Last Update Submitted: 2016-03-18
• Study First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibandronate 15-Minute Infusion	Ibandronate	Participants will receive ibandronate IV infusions over a 15-minute interval.
Ibandronate 60-Minute Infusion	Ibandronate	Participants will receive ibandronate IV infusions over a 60-minute interval.

Primary Outcome Measures

Name	Time	Method
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula	28 days after last infusion (approximately 2 years)

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Bone Pain According to Visual Analog Scale (VAS)	Every 3 weeks up to approximately 6 months
Karnofsky Index score	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