Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716792
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain; Bone Neoplasms; Neoplasm Metastasis Drug: Ibandronate Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

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 Name: 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 Name: Bondronat




Primary Outcome Measures :
  1. Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula [ Time Frame: 28 days after last infusion (approximately 2 years) ]

Secondary Outcome Measures :
  1. Number of Participants with Bone Pain According to Visual Analog Scale (VAS) [ Time Frame: Every 3 weeks up to approximately 6 months ]
  2. 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 ]
  3. Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder [ Time Frame: Up to approximately 7 months ]
  4. Karnofsky Index score [ Time Frame: Every 3 weeks up to approximately 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716792


Locations
Layout table for location information
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, 75475
Paris, France, 75674
Paris, France, 75970
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Chair: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02716792    
Other Study ID Numbers: ML19188
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Bone Neoplasms
Bone Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Neoplasms by Site
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs