A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
A Randomized, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain
1 other identifier
interventional
96
16 countries
41
Brief Summary
This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pain
Started Aug 2005
Typical duration for phase_3 pain
41 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
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedAugust 16, 2017
August 1, 2017
2.3 years
December 10, 2004
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain, as measured by Brief Pain Inventory and analgesic use
Week 24
Secondary Outcomes (4)
Performance score and QoL measures
Week 24
AEs and laboratory parameters
Throughout study
Opioid side effects
Throughout study
Skeletal-related events
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- patients with malignant bone disease;
- patients with moderate to severe pain.
You may not qualify if:
- patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
- patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
- untreated esophagitis or gastric ulcers;
- recent or pre-scheduled radiotherapy to bone;
- patients who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Bahía Blanca, B8001HXM, Argentina
Unknown Facility
Buenos Aires, 1426, Argentina
Unknown Facility
Buenos Aires, C1426BOR, Argentina
Unknown Facility
Rosario, 2000, Argentina
Unknown Facility
Santa Fe, 03000, Argentina
Unknown Facility
Adelaide, 5011, Australia
Unknown Facility
Brisbane, 4101, Australia
Unknown Facility
Santiago, Chile
Unknown Facility
Viña del Mar, Chile
Unknown Facility
Hamburg, 22143, Germany
Unknown Facility
Kalyftaki Kifissia, Greece
Unknown Facility
Thessaloniki, 57010, Greece
Unknown Facility
Guatemala City, Guatemala
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Budapest, 1529, Hungary
Unknown Facility
Deszk, 6772, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Rozzano, 20089, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
La Paz, 23040, Mexico
Unknown Facility
Mexicali, 21100, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Monterrey, 64320, Mexico
Unknown Facility
Panama City, 83-0669, Panama
Unknown Facility
Poznan, 60-569, Poland
Unknown Facility
Poznan, 61-878, Poland
Unknown Facility
San Juan, 00935, Puerto Rico
Unknown Facility
Kazan', 420029, Russia
Unknown Facility
Moscow, 115478, Russia
Unknown Facility
Moscow, 117837, Russia
Unknown Facility
Moscow, 125284, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Obninsk, 249020, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Saint Petersburg, 197758, Russia
Unknown Facility
Sankt Gallen, 9007, Switzerland
Unknown Facility
Manchester, M20 4BX, United Kingdom
Unknown Facility
Sutton, SM2 5PT, United Kingdom
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
August 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
August 16, 2017
Record last verified: 2017-08