Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00099177




Registration number
NCT00099177
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/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Scientific 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
Secondary ID [1] 0 0
BO18039
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 50mg po from day 22 to week 24

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 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
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Argentina
State/province [4] 0 0
Bahia Blanca
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Rosario
Country [7] 0 0
Argentina
State/province [7] 0 0
Santa Fe
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago
Country [9] 0 0
Chile
State/province [9] 0 0
Vina Del Mar
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Greece
State/province [11] 0 0
Kalyftaki Kifissia
Country [12] 0 0
Greece
State/province [12] 0 0
Thessaloniki
Country [13] 0 0
Guatemala
State/province [13] 0 0
Guatemala City
Country [14] 0 0
Hungary
State/province [14] 0 0
Budapest
Country [15] 0 0
Hungary
State/province [15] 0 0
Deszk
Country [16] 0 0
Hungary
State/province [16] 0 0
Szeged
Country [17] 0 0
Italy
State/province [17] 0 0
Rozzano
Country [18] 0 0
Italy
State/province [18] 0 0
Torino
Country [19] 0 0
Mexico
State/province [19] 0 0
La Paz
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexicali
Country [21] 0 0
Mexico
State/province [21] 0 0
Mexico City
Country [22] 0 0
Mexico
State/province [22] 0 0
Monterrey
Country [23] 0 0
Panama
State/province [23] 0 0
Panama City
Country [24] 0 0
Poland
State/province [24] 0 0
Poznan
Country [25] 0 0
Puerto Rico
State/province [25] 0 0
San Juan
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kazan
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Obninsk
Country [29] 0 0
Russian Federation
State/province [29] 0 0
St Petersburg
Country [30] 0 0
Switzerland
State/province [30] 0 0
St Gallen
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Manchester
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Sutton

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/NCT00099177