Back to resultsA Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
Primary Purpose
Pain; Bone Neoplasms; Neoplasm Metastasis
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
About this trial
This is an interventional treatment trial for Pain; Bone Neoplasms; Neoplasm Metastasis
Eligibility Criteria
Inclusion Criteria:
- Female participants greater than or equal to (>=) 18 years of age
- Breast cancer with bone metastases
- Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
- Stable analgesic regimen.
Exclusion Criteria:
- Participants who have received a bisphosphonate within 3 weeks of start of trial
- Radiotherapy to bone within 4 weeks of enrolment
- Hypersensitivity to ibandronate
- Central nervous system (CNS) or meningeal metastases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ibandronate
Arm Description
Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
Outcomes
Primary Outcome Measures
Percentage of participants with >=25% reduction in mean pain
Percentage of participants with =<35% increase in mean analgesic consumption
Secondary Outcome Measures
Change from Baseline in average pain score
Analgesic consumption
Pain response
Time to pain response
Full Information
NCT ID
NCT02553707
First Posted
September 16, 2015
Last Updated
September 16, 2015
Sponsor
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT02553707
Brief Title
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
Official Title
Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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 study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibandronate
Arm Type
Experimental
Arm Description
Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bondronat
Intervention Description
Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
Primary Outcome Measure Information:
Title
Percentage of participants with >=25% reduction in mean pain
Time Frame
up to Day 6
Title
Percentage of participants with =<35% increase in mean analgesic consumption
Time Frame
up to Days 7
Secondary Outcome Measure Information:
Title
Change from Baseline in average pain score
Time Frame
Baseline (Days 0), 5, and 7
Title
Analgesic consumption
Time Frame
up to Day 7
Title
Pain response
Time Frame
up to Day 7
Title
Time to pain response
Time Frame
up to Day 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female participants greater than or equal to (>=) 18 years of age
Breast cancer with bone metastases
Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
Stable analgesic regimen.
Exclusion Criteria:
Participants who have received a bisphosphonate within 3 weeks of start of trial
Radiotherapy to bone within 4 weeks of enrolment
Hypersensitivity to ibandronate
Central nervous system (CNS) or meningeal metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Budapest
ZIP/Postal Code
1031
Country
Hungary
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Gyor
ZIP/Postal Code
9002
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
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