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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502736
First Posted: July 18, 2007
Last Update Posted: January 22, 2014
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 (Responsible Party):
Hoffmann-La Roche
  Purpose
This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant 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 Neoplasms; 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 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 and analgesic consumption [ Time Frame: Days 1, 7 and 14 ]

Secondary Outcome Measures:
  • AEs and laboratory parameters [ Time Frame: Days 1, 4 and 7 ]
  • Serum creatinine [ Time Frame: Days 1, 4 and 7 ]
  • Karnofsky index [ Time Frame: Day 7 ]

Enrollment: 13
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=18 years of age;
  • breast cancer;
  • bone metastases;
  • moderate to severe pain;
  • adequate renal function.

Exclusion Criteria:

  • bisphosphonate treatment within 3 weeks of study enrollment.
  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): NCT00502736


Locations
Turkey
Ankara, Turkey, 06018
Ankara, Turkey, 06230
Istanbul, Turkey, 34300
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Shhiye, Ankara, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502736     History of Changes
Other Study ID Numbers: ML20684
First Submitted: July 17, 2007
First Posted: July 18, 2007
Last Update Posted: January 22, 2014
Last Verified: January 2014

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