Breast NeoplasmsBONANCT01198457
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment
An observational study of Breast Neoplasms and Prostatic Neoplasms, run by Bayer at 1 site in Czechia.
Trial summary
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma
- What is being tested?
- Clodronate (Bonefos, BAY94-8393)
- How many people
- 147 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2009to Jun 2010
- Phase
- Observational
- 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
Study population: Random group of patients in oncology clinic
Who may be able to join
- Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors
- Bone metastases
- Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos.
- By agreeing to usage of patients diaries and goodwill with accounting of tablets
Who cannot join
- According to SmPC (Summary of Product Characteristics) Bonefos.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).
- Conditions
- Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis
- Being tested
- Clodronate (Bonefos, BAY94-8393)
- Keywords
- Clodronate, Compliance
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clodronate (Bonefos, BAY94-8393)Drug
Random group of patients in oncology clinic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Clodronate (Bonefos, BAY94-8393) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment with oral clodronate (PDC, proportion of days covered).
Measured: 12 months of therapy.
Secondary outcomes (2)
Efficacy evaluation of the therapy based on incidence of skeletal events
Measured: 12 months
Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198457
- Sponsor's protocol ID
- 14561
- Other IDs
- BO0910CZ
- Acronym
- BONA
- Status last verified
- Sep 2012
- First submitted
- 29 Jul 2010
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events
- ClinicalTrials.gov ID
- NCT01198457
- Acronym / sponsor ID
- BONA / 14561
- Conditions
- Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis
- Keywords
- Clodronate, Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Sep 2010 (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.
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Clodronate (Bonefos, BAY94-8393) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random group of patients in oncology clinic
Key inclusion criteria (4 listed)
- Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors
- Bone metastases
- Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos.
- By agreeing to usage of patients diaries and goodwill with accounting of tablets
Key exclusion criteria (1 listed)
- According to SmPC (Summary of Product Characteristics) Bonefos.
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 |
|---|---|---|
| Clodronate (Bonefos, BAY94-8393)Random group of patients in oncology clinic | Drug | Group 1 |
Primary outcome
Adherence to treatment with oral clodronate (PDC, proportion of days covered).
Time frame: 12 months of therapy.
2 secondary outcomes
Efficacy evaluation of the therapy based on incidence of skeletal events
Time frame: 12 months
Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire
Time frame: 12 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 7 Sep 2012.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Prostatic Neoplasms, run by Bayer at 1 site in Czechia.
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 1 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 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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.
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?
Adherence to treatment with oral clodronate (PDC, proportion of days covered). (time frame: 12 months of therapy.). 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 7 Sep 2012.