A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
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.
1 other identifier
interventional
N/A
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2007
Shorter than P25 for phase_2 pain
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedAugust 16, 2017
August 1, 2017
8 months
May 23, 2007
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Days 5 - 7
Secondary Outcomes (4)
Mean worst pain score over first 7 days
Day 7
Analgesic consumption
Day 7
Karnofsky index
Day 7
AEs, laboratory parameters
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Alexandroupoli, Greece
Unknown Facility
Athens, Greece
Unknown Facility
Haidari, Greece
Unknown Facility
Pátrai, Greece
Unknown Facility
Piraeus, Greece
Unknown Facility
Thessaloniki, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 24, 2007
Study Start
June 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
August 16, 2017
Record last verified: 2017-08