Skip to main content
OpenTrials
Completed

NCT Number: NCT02716792

A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Amboise, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibandronate

Drug

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

Primary outcomes

  1. Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula

    Time frame: 28 days after last infusion (approximately 2 years)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2016
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.