Pain; Bone Neoplasms; Neoplasm MetastasisPhase 4NCT02564107
A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
A Phase 4 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 8 sites in Bulgaria.
Trial summary
This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain; Bone Neoplasms; Neoplasm Metastasis
- What is being tested?
- Ibandronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesBulgaria
- Study dates
- Nov 2004to Apr 2006
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females at least 18 years of age
- Breast cancer
- Bone metastases
Who cannot join
- Use of bisphosphonates within the last 3 months
- Prior use of gallium nitrate or metastron
- Severely impaired renal function
- Hypocalcemia or primary hyperparathyroidism
- Central nervous system (CNS) metastases
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Bulgaria8 sites
Study site
Plovdiv, 4004
Study site
Shumen
Study site
Sofia, 1527
Study site
Sofia, 1756
Study site
Sofia, 1784
Study site
Stara Zagora, 8000
Study site
Varna, 9010
Study site
Veliko Tarnovo, 5000
About this study
Official title: An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 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, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate | Experimental | Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks. Receives: Drug: Ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
Measured: Up to 25 weeks
Secondary outcomes (5)
Incidence of bone pain according to participant questionnaire
Measured: Up to 25 weeks
Analgesic consumption according to participant questionnaire
Measured: Up to 25 weeks
Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
Measured: Up to 25 weeks
Short Form 36 (SF-36) score
Measured: Up to 25 weeks
Incidence of adverse events (AEs)
Measured: Up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2004
- Primary completionApr 2006
- Study completionApr 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT02564107
- Sponsor's protocol ID
- ML18044
- Status last verified
- Nov 2016
- First submitted
- 28 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
- An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
- ClinicalTrials.gov ID
- NCT02564107
- Acronym / sponsor ID
- ML18044
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 30 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 evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | Experimental | Drug: IbandronateFemale participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females at least 18 years of age
- Breast cancer
- Bone metastases
Key exclusion criteria (5 listed)
- Use of bisphosphonates within the last 3 months
- Prior use of gallium nitrate or metastron
- Severely impaired renal function
- Hypocalcemia or primary hyperparathyroidism
- Central nervous system (CNS) 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, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks. | Drug | Ibandronate |
Primary outcome
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
Time frame: Up to 25 weeks
5 secondary outcomes
Incidence of bone pain according to participant questionnaire
Time frame: Up to 25 weeks
Analgesic consumption according to participant questionnaire
Time frame: Up to 25 weeks
Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
Time frame: Up to 25 weeks
Short Form 36 (SF-36) score
Time frame: Up to 25 weeks
Incidence of adverse events (AEs)
Time frame: Up to approximately 7 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 8 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 3 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: 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 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR) (time frame: Up to 25 weeks). 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.