Back to resultsA Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
Primary Purpose
Pain; Bone Neoplasms; Neoplasm Metastasis
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
ibandronate [Bondronat]
Sponsored by
About this trial
This is an interventional treatment trial for Pain; Bone Neoplasms; Neoplasm Metastasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Pain and analgesic consumption
Secondary Outcome Measures
AEs and laboratory parameters
Serum creatinine
Karnofsky index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00502736
Brief Title
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain; Bone Neoplasms; Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bondronat]
Intervention Description
6mg iv on days 1-3
Primary Outcome Measure Information:
Title
Pain and analgesic consumption
Time Frame
Days 1, 7 and 14
Secondary Outcome Measure Information:
Title
AEs and laboratory parameters
Time Frame
Days 1, 4 and 7
Title
Serum creatinine
Time Frame
Days 1, 4 and 7
Title
Karnofsky index
Time Frame
Day 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Shhiye, Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
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