A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain;; Bone Neoplasms;; Neoplasm Metastasis
Intervention: ibandronate [Bondronat] (Drug); zoledronic acid (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain, as measured by Brief Pain Inventory and analgesic use
Secondary outcome: Performance score and QoL measuresAEs and laboratory parameters Opioid side effects Skeletal-related events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with malignant bone disease;
- patients with moderate to severe pain.
Exclusion Criteria:
- 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.
Locations and Contacts
ROSARIO 2000, Argentina
SANTA FE 03000, Argentina
BUENOS AIRES 1426, Argentina
BUENOS AIRES C1426BOR, Argentina
BAHIA BLANCA B8001HXM, Argentina
BRISBANE 4101, Australia
ADELAIDE 5011, Australia
VINA DEL MAR, Chile
SANTIAGO, Chile
HAMBURG 22143, Germany
THESSALONIKI 57010, Greece
KALYFTAKI KIFISSIA, Greece
GUATEMALA CITY, Guatemala
DESZK 6772, Hungary
SZEGED 6720, Hungary
BUDAPEST 1122, Hungary
BUDAPEST 1529, Hungary
ROZZANO 20089, Italy
TORINO 10126, Italy
MEXICO CITY 14050, Mexico
MEXICALI 21100, Mexico
LA PAZ 23040, Mexico
MONTERREY 64320, Mexico
PANAMA CITY 83-0669, Panama
POZNAN 60-569, Poland
POZNAN 61-878, Poland
SAN JUAN 00935, Puerto Rico
MOSCOW 115478, Russian Federation
MOSCOW 117837, Russian Federation
KAZAN 420029, Russian Federation
ST PETERSBURG 197758, Russian Federation
ST PETERSBURG 197022, Russian Federation
OBNINSK 249020, Russian Federation
MOSCOW, Russian Federation
MOSCOW 125284, Russian Federation
ST GALLEN 9007, Switzerland
SUTTON SM2 5PT, United Kingdom
MANCHESTER M20 4BX, United Kingdom
MIAMI, Florida 33136, United States
MACON, Georgia 31201, United States
HOUSTON, Texas 77030, United States
Additional Information
Starting date: August 2005
Ending date: January 2007
Last updated: May 20, 2008
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