PainPhase 2NCT00478270
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
A Phase 2 study testing ibandronate [Bondronat] in people with Pain and Bone Neoplasm, run by Hoffmann-La Roche at 6 sites in Greece.
Trial summary
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. 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]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesGreece
- Study dates
- Jun 2007to Feb 2008
- Phase
- Phase 2
- 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
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean worst pain score >=4 during 3 day baseline period;
- stable dose of analgesics over a 3 day baseline period;
- adequate renal function.
Who cannot join
- bisphosphonate treatment within 3 weeks of study enrollment;
- a change in antineoplastic treatment within 6 weeks of study enrollment;
- bone radiation within 2 weeks of study enrollment;
- active infection.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
Study site
Alexandroupoli
Study site
Athens
Study site
Haidari
Study site
Pátrai
Study site
Piraeus
Study site
Thessaloniki
About this study
Official title: An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
- Conditions
- Pain, Bone Neoplasm, Neoplasm Metastasis
- Being tested
- ibandronate [Bondronat]
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ibandronate [Bondronat] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Measured: Days 5 - 7
Secondary outcomes (4)
Mean worst pain score over first 7 days
Measured: Day 7
Analgesic consumption
Measured: Day 7
Karnofsky index
Measured: Day 7
AEs, laboratory parameters
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 posted24 May 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00478270
- Sponsor's protocol ID
- ML20247
- Status last verified
- Aug 2017
- First submitted
- 23 May 2007
- 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
- An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.
- ClinicalTrials.gov ID
- NCT00478270
- Acronym / sponsor ID
- ML20247
- Conditions
- Pain, Bone Neoplasm, Neoplasm Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 May 2007 (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 single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibandronate [Bondronat] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean worst pain score >=4 during 3 day baseline period;
- stable dose of analgesics over a 3 day baseline period;
Key exclusion criteria (4 listed)
- bisphosphonate treatment within 3 weeks of study enrollment;
- a change in antineoplastic treatment within 6 weeks of study enrollment;
- bone radiation within 2 weeks of study enrollment;
- active infection.
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 | Drug | 1 |
Primary outcome
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Time frame: Days 5 - 7
4 secondary outcomes
Mean worst pain score over first 7 days
Time frame: Day 7
Analgesic consumption
Time frame: Day 7
Karnofsky index
Time frame: Day 7
AEs, laboratory parameters
Time frame: Throughout study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ibandronate [Bondronat] in people with Pain and Bone Neoplasm, run by Hoffmann-La Roche at 6 sites in Greece.
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 6 inclusion and 4 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: withdrawn, 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 6 sites in Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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 response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption (time frame: Days 5 - 7). 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.