Pain; Bone Neoplasms; Neoplasm MetastasisPhase 3NCT02561039
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
A Phase 3 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 9 sites in Bulgaria.
Trial summary
This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and 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 Neoplasms; Neoplasm Metastasis
- What is being tested?
- Ibandronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 9 sitesBulgaria
- Study dates
- Dec 2006to Mar 2008
- 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
- Adults at least 18 years of age
- Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
- Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
- Radiologically confirmed bone disease disease
Who cannot join
- Previous treatment with ibandronate (Bondronat) within previous 2 months
- Severely impaired renal function
- Known brain metastases
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Bulgaria9 sites
Study site
Burgas, 8000
Study site
Haskovo, 6300
Study site
Pleven, 5800
Study site
Plovdiv, 4004
Study site
Sofia, 1757
Study site
Sofia, 1784
Study site
Varna, 9002
Study site
Varna, 9010
Study site
Vratsa, 3000
About this study
Official title: Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies
This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.
- Being tested
- Ibandronate
- 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.
IbandronateDrug
Also called Bondronat
Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate IV Infusion | Experimental | Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months. Receives: Drug: Ibandronate |
| Ibandronate PO Tablet | Experimental | Participants will receive ibandronate, 50 mg PO daily, for 4 months. Receives: Drug: Ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to reduction in BPI most acute pain score from Baseline
Measured: Month 4
Change in KPI
Measured: Baseline to Month 4
Secondary outcomes (3)
Time to onset of decrease in most acute pain score
Measured: Up to 4 months
Analgesic consumption according to participant diary
Measured: Up to 5 months
Incidence of adverse events
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain; Bone Neoplasms; Neoplasm MetastasisStudies 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561039
- Sponsor's protocol ID
- ML20713
- Status last verified
- Nov 2016
- First submitted
- 24 Sep 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02561039
- Acronym / sponsor ID
- ML20713
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Sep 2015 (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 study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate IV Infusion | Experimental | Drug: IbandronateParticipants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months. |
| Ibandronate PO Tablet | Experimental | Drug: IbandronateParticipants will receive ibandronate, 50 mg PO daily, for 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults at least 18 years of age
- Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
- Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
- Radiologically confirmed bone disease disease
Key exclusion criteria (3 listed)
- Previous treatment with ibandronate (Bondronat) within previous 2 months
- Severely impaired renal function
- Known brain metastases
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 |
|---|---|---|
| IbandronateAlso: BondronatParticipants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months. | Drug | Ibandronate IV Infusion, Ibandronate PO Tablet |
Primary outcome
Response rate according to reduction in BPI most acute pain score from Baseline
Time frame: Month 4
Change in KPI
Time frame: Baseline to Month 4
3 secondary outcomes
Time to onset of decrease in most acute pain score
Time frame: Up to 4 months
Analgesic consumption according to participant diary
Time frame: Up to 5 months
Incidence of adverse events
Time frame: Up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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 chair
Hoffmann-La Roche
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 9 sites in Bulgaria.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Bulgaria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate according to reduction in BPI most acute pain score from Baseline (time frame: Month 4). The study lists 2 primary outcomes in all. 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 2 Nov 2016.