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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00099203




Registration number
NCT00099203
Ethics application status
Date submitted
10/12/2004
Date registered
10/12/2004
Date last updated
16/08/2017

Titles & IDs
Public title
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
Scientific 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
Secondary ID [1] 0 0
BO18040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Bone Neoplasm 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ibandronate [Bondronat]
Treatment: Drugs - zoledronic acid

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: ibandronate [Bondronat]
6mg iv on days 1-3, and every 3-4 weeks

Treatment: Drugs: zoledronic acid
4mg iv on day 1 and every 3-4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain, as measured by Brief Pain Inventory and analgesic use
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Performance score and QoL measures
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
AEs and laboratory parameters
Timepoint [2] 0 0
Throughout study
Secondary outcome [3] 0 0
Opioid side effects
Timepoint [3] 0 0
Throughout study
Secondary outcome [4] 0 0
Skeletal-related events
Timepoint [4] 0 0
Throughout study

Eligibility
Key inclusion criteria
* patients with malignant bone disease;
* patients with moderate to severe pain.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Waratah
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
La Plata
Country [18] 0 0
Argentina
State/province [18] 0 0
Lanus
Country [19] 0 0
Argentina
State/province [19] 0 0
Mendoza
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Turnhout
Country [22] 0 0
Belgium
State/province [22] 0 0
Wilrijk
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Chile
State/province [24] 0 0
Santiago
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
Germany
State/province [28] 0 0
Dessau
Country [29] 0 0
Germany
State/province [29] 0 0
Duisburg
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Germany
State/province [31] 0 0
Trier
Country [32] 0 0
Guatemala
State/province [32] 0 0
Guatemala City
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyor
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Mexico
State/province [36] 0 0
Chihuahua
Country [37] 0 0
Mexico
State/province [37] 0 0
Merida
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico City
Country [39] 0 0
Panama
State/province [39] 0 0
Panama City
Country [40] 0 0
Poland
State/province [40] 0 0
Lodz
Country [41] 0 0
Poland
State/province [41] 0 0
Olsztyn
Country [42] 0 0
Poland
State/province [42] 0 0
Otwock
Country [43] 0 0
Puerto Rico
State/province [43] 0 0
Ponce
Country [44] 0 0
Puerto Rico
State/province [44] 0 0
San Juan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Kazan
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Obninsk
Country [48] 0 0
Russian Federation
State/province [48] 0 0
St Petersburg
Country [49] 0 0
Switzerland
State/province [49] 0 0
Baden
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Exeter
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00099203