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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 website
https://clinicaltrials.gov/show/NCT00099177
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00099177