PainPhase 3NCT00099177
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
A Phase 3 study testing ibandronate [Bondronat] and zoledronic acid in people with Pain and Bone Neoplasm, run by Hoffmann-La Roche at 41 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Bone Neoplasm, Neoplasm Metastasis
- What is being tested?
- ibandronate [Bondronat] and zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 41 sitesin 16 countries
- Study dates
- Aug 2005to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with malignant bone disease;
- patients with moderate to severe pain.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 16 countries.
41 sites in 16 countries
Russia8 sites
Study site
Kazan', 420029
Study site
Moscow, 115478
Study site
Moscow, 117837
Study site
Moscow, 125284
Study site
Moscow
Study site
Obninsk, 249020
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197758
Argentina5 sites
Study site
Bahía Blanca, B8001HXM
Study site
Buenos Aires, 1426
Study site
Buenos Aires, C1426BOR
Study site
Rosario, 2000
Study site
Santa Fe, 03000
Hungary4 sites
Study site
Budapest, 1122
Study site
Budapest, 1529
Study site
Deszk, 6772
Study site
Szeged, 6720
Mexico4 sites
Study site
La Paz, 23040
Study site
Mexicali, 21100
Study site
Mexico City, 14050
Study site
Monterrey, 64320
United States3 sites
Study site
Houston, Texas, 77030
Study site
Macon, Georgia, 31201
Study site
Miami, Florida, 33136
United Kingdom2 sites
Study site
Manchester, M20 4BX
Study site
Sutton, SM2 5PT
About this study
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
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.
- Conditions
- Pain, Bone Neoplasm, Neoplasm Metastasis
- Being tested
- ibandronate [Bondronat], zoledronic acid
- Medical subject headings
- Pain, Bone Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronate [Bondronat]Drug
6mg iv on days 1-3, and 50mg po from day 22 to week 24
zoledronic acidDrug
4mg iv on day 1, and every 3-4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bondronat] |
| 2 | Active comparator | Not described Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, as measured by Brief Pain Inventory and analgesic use
Measured: Week 24
Secondary outcomes (4)
Performance score and QoL measures
Measured: Week 24
AEs and laboratory parameters
Measured: Throughout study
Opioid side effects
Measured: Throughout study
Skeletal-related events
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2004 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099177
- Sponsor's protocol ID
- BO18039
- Status last verified
- Aug 2017
- First submitted
- 10 Dec 2004
- Last updated
- 16 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00099177
- Acronym / sponsor ID
- BO18039
- Conditions
- Pain, Bone Neoplasm, Neoplasm Metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bondronat] |
| 2 | Active comparator | Drug: zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with malignant bone disease;
- patients with moderate to severe pain.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibandronate [Bondronat]6mg iv on days 1-3, and 50mg po from day 22 to week 24 | Drug | 1 |
| zoledronic acid4mg iv on day 1, and every 3-4 weeks | Drug | 2 |
Primary outcome
Pain, as measured by Brief Pain Inventory and analgesic use
Time frame: Week 24
4 secondary outcomes
Performance score and QoL measures
Time frame: Week 24
AEs and laboratory parameters
Time frame: Throughout study
Opioid side effects
Time frame: Throughout study
Skeletal-related events
Time frame: Throughout study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
41 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibandronate [Bondronat] and zoledronic acid in people with Pain and Bone Neoplasm, run by Hoffmann-La Roche at 41 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Russia, Argentina, Hungary, Mexico, United States and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, as measured by Brief Pain Inventory and analgesic use (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.