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

January 20, 2014 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

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

  • Turkey
      • Ankara, Turkey, 06230
      • Ankara, Turkey, 06018
      • Istanbul, Turkey, 34300
      • Istanbul, Turkey, 34390
      • Izmir, Turkey, 35100
      • Shhiye, Ankara, Turkey, 06100

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:

  • 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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ibandronate [Bondronat]
6mg iv on days 1-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and analgesic consumption
Time Frame: Days 1, 7 and 14
Days 1, 7 and 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Karnofsky index
Time Frame: Day 7
Day 7
AEs and laboratory parameters
Time Frame: Days 1, 4 and 7
Days 1, 4 and 7
Serum creatinine
Time Frame: Days 1, 4 and 7
Days 1, 4 and 7

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, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 18, 2007

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20684

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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