Back to resultsA Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
Primary Purpose
Pain, Bone Neoplasm, Neoplasm Metastasis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ibandronate [Bondronat]
zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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 the 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pain, as measured by Brief Pain Inventory and analgesic use
Secondary Outcome Measures
Performance score and QoL measures
AEs and laboratory parameters
Opioid side effects
Skeletal-related events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00099203
Brief Title
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
Official Title
A Randomized, Placebo-controlled, 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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the efficacy of intravenous 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 and then every 3-4 weeks) 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.
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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bondronat]
Intervention Description
6mg iv on days 1-3, and every 3-4 weeks
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Description
4mg iv on day 1 and every 3-4 weeks
Primary Outcome Measure Information:
Title
Pain, as measured by Brief Pain Inventory and analgesic use
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Performance score and QoL measures
Time Frame
Week 24
Title
AEs and laboratory parameters
Time Frame
Throughout study
Title
Opioid side effects
Time Frame
Throughout study
Title
Skeletal-related events
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 the 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.
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-5208
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1449
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1406FWY
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1408INH
Country
Argentina
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
City
Lanus
ZIP/Postal Code
B1824DLR
Country
Argentina
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
City
Waratah
ZIP/Postal Code
2298
Country
Australia
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Santiago
Country
Chile
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Nice
ZIP/Postal Code
06189
Country
France
City
Paris
ZIP/Postal Code
75248
Country
France
City
Dessau
ZIP/Postal Code
06846
Country
Germany
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Trier
ZIP/Postal Code
54290
Country
Germany
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
City
Guatemala City
Country
Guatemala
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Gyor
ZIP/Postal Code
9002
Country
Hungary
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
City
Merida
ZIP/Postal Code
97500
Country
Mexico
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
City
Panama City
Country
Panama
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
City
Ponce
ZIP/Postal Code
00733-1324
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117837
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Obninsk
ZIP/Postal Code
249020
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
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