A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer
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
1 other identifier
interventional
334
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2006
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedMarch 23, 2016
March 1, 2016
2.4 years
March 18, 2016
March 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
28 days after last infusion (approximately 2 years)
Secondary Outcomes (4)
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
Study Arms (2)
Ibandronate 15-Minute Infusion
EXPERIMENTALParticipants will receive ibandronate IV infusions over a 15-minute interval.
Ibandronate 60-Minute Infusion
ACTIVE COMPARATORParticipants will receive ibandronate IV infusions over a 60-minute interval.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- Uncontrolled cardiac disorder
- Hypercalcaemia (\> 2.7 millimoles per liter \[mmol/L\]), hypocalcaemia (\< 2 mmol/L)
- Participant receiving nephrotoxic chemotherapy
- Bisphosphonate therapy in the 3 weeks before randomization
- Known hypersensitivity to ibandronate or other bisphosphonates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Amboise, 37403, France
Unknown Facility
Angers, 49933, France
Unknown Facility
Bayonne, 64100, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Boulogne-Billancourt, 92100, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Chambéry, 73011, France
Unknown Facility
Clermont-Ferrand, 63011, France
Unknown Facility
Évreux, 27000, France
Unknown Facility
Gap, 05007, France
Unknown Facility
Hyères, 83400, France
Unknown Facility
Le Chesnay, 78157, France
Unknown Facility
Metz-Tessy, 74370, France
Unknown Facility
Nantes, 44202, France
Unknown Facility
Neuilly-sur-Seine, 92200, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Rennes, 35042, France
Unknown Facility
Rouen, 76000, France
Unknown Facility
Saint-Brieuc, 22015, France
Unknown Facility
Saint-Cloud, 92210, France
Unknown Facility
Saint-Grégoire, 35768, France
Unknown Facility
Saint-Jean, 31240, France
Unknown Facility
Salouël, 80480, France
Unknown Facility
Strasbourg, 67010, France
Unknown Facility
Trappes, 78190, France
Unknown Facility
Valenciennes, 59322, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Villejuif, 94804, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2016
First Posted
March 23, 2016
Study Start
January 1, 2006
Primary Completion
June 1, 2008
Study Completion
August 1, 2008
Last Updated
March 23, 2016
Record last verified: 2016-03