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

March 18, 2016 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amboise, France, 37403
      • Angers, France, 49933
      • Bayonne, France, 64100
      • Besancon, France, 25030
      • Boulogne-billancourt, France, 92100
      • Brest, France, 29609
      • Chambery, France, 73011
      • Clermont Ferrand, France, 63011
      • Evreux, France, 27000
      • GAP, France, 05007
      • Hyeres, France, 83400
      • Le Chesnay, France, 78157
      • Metz Tessy, France, 74370
      • Nantes, France, 44202
      • Neuilly-sur-seine, France, 92200
      • Paris, France, 75970
      • Paris, France, 75475
      • Paris, France, 75674
      • Rennes, France, 35042
      • Rouen, France, 76000
      • Saint Brieuc, France, 22015
      • Saint Gregoire, France, 35768
      • Saint Jean, France, 31240
      • Saint-cloud, France, 92210
      • Salouel, France, 80480
      • Strasbourg, France, 67010
      • Trappes, France, 78190
      • Valenciennes, France, 59322
      • Vandoeuvre Les Nancy, France, 54511
      • Villejuif, France, 94804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate 15-Minute Infusion
Participants will receive ibandronate IV infusions over a 15-minute interval.
Drug: Ibandronate
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).
Other Names:
  • Bondronat
Active Comparator: Ibandronate 60-Minute Infusion
Participants will receive ibandronate IV infusions over a 60-minute interval.
Drug: Ibandronate
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).
Other Names:
  • Bondronat

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Bone Pain According to Visual Analog Scale (VAS)
Time Frame: Every 3 weeks up to approximately 6 months
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
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
Up to approximately 7 months
Karnofsky Index score
Time Frame: Every 3 weeks up to approximately 6 months
Every 3 weeks up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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