Back to resultsA Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
Primary Purpose
Pain, Bone Neoplasm, Neoplasm Metastasis
Status
Withdrawn
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
ibandronate [Bondronat]
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Secondary Outcome Measures
Mean worst pain score over first 7 days
Analgesic consumption
Karnofsky index
AEs, laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478270
Brief Title
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Bone Neoplasm, 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
0 (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 response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Time Frame
Days 5 - 7
Secondary Outcome Measure Information:
Title
Mean worst pain score over first 7 days
Time Frame
Day 7
Title
Analgesic consumption
Time Frame
Day 7
Title
Karnofsky index
Time Frame
Day 7
Title
AEs, laboratory parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
Alexandroupolis
Country
Greece
City
Athens
Country
Greece
City
Haidari
Country
Greece
City
Patras
Country
Greece
City
Piraeus
Country
Greece
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
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