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A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478270
First Posted: May 24, 2007
Last Update Posted: August 16, 2017
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.
Information provided by:
Hoffmann-La Roche
  Purpose
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Condition Intervention Phase
Pain Bone Neoplasm Neoplasm Metastasis Drug: ibandronate [Bondronat] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption [ Time Frame: Days 5 - 7 ]

Secondary Outcome Measures:
  • Mean worst pain score over first 7 days [ Time Frame: Day 7 ]
  • Analgesic consumption [ Time Frame: Day 7 ]
  • Karnofsky index [ Time Frame: Day 7 ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bondronat]
6mg iv on days 1-3

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • breast cancer;
  • bone metastases;
  • mean worst pain score >=4 during 3 day baseline period;
  • stable dose of analgesics over a 3 day baseline period;
  • adequate renal function.

Exclusion Criteria:

  • bisphosphonate treatment within 3 weeks of study enrollment;
  • a change in antineoplastic treatment within 6 weeks of study enrollment;
  • bone radiation within 2 weeks of study enrollment;
  • active infection.
  Contacts and Locations
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): NCT00478270


Locations
Greece
Alexandroupolis, Greece
Athens, Greece
Haidari, Greece
Patras, Greece
Piraeus, Greece
Thessaloniki, Greece
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00478270     History of Changes
Other Study ID Numbers: ML20247
First Submitted: May 23, 2007
First Posted: May 24, 2007
Last Update Posted: August 16, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs