Bone NeoplasmsBICAMNCT00909142
Bonefos and the Consumption of Analgesics
An observational study of Bone Neoplasms, run by Bayer at 1 site in Czechia.
Trial summary
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasms
- What is being tested?
- Bonefos (Clodronate, BAY94-8393)
- How many people
- 149 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2007to Feb 2009
- 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 sample of cancer patients visting oncologist or urologist ambulance who are suitable for standard clodronate treatment.
Who may be able to join
- Breast cancer or prostate cancer or multiple myeloma.
- Bone metastasis.
- Ability to use analgesics and clodronate 1600 mg/day.
Who cannot join
- Hypersensitivity to bisphosphonates.
- Clodronate in previous therapy.
- Concomitant use of other bisphosphonates.
- Serious renal insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.
- Conditions
- Bone Neoplasms
- Being tested
- Bonefos (Clodronate, BAY94-8393)
- Keywords
- Breast cancer, Prostate cancer, Multiple myeloma
- Medical subject headings
- Bone Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonefos (Clodronate, BAY94-8393)Drug
Patients in regular clinical practice receiving Bonefos according to local drug information
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Not described Receives: Drug: Bonefos (Clodronate, BAY94-8393) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma
Measured: 12 months
Secondary outcomes (1)
Decrease in pain measured by VAS (Visual Analogue Scale)
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 posted27 May 2009 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- 149 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
- NCT00909142
- Sponsor's protocol ID
- 14236
- Other IDs
- Bonefos
- Acronym
- BICAM
- Status last verified
- Apr 2012
- First submitted
- 25 May 2009
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis
- ClinicalTrials.gov ID
- NCT00909142
- Acronym / sponsor ID
- BICAM / 14236
- Conditions
- Bone Neoplasms
- Keywords
- Breast cancer, Prostate cancer, Multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 May 2009 (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.
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Drug: Bonefos (Clodronate, BAY94-8393) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample of cancer patients visting oncologist or urologist ambulance who are suitable for standard clodronate treatment.
Key inclusion criteria (3 listed)
- Breast cancer or prostate cancer or multiple myeloma.
- Bone metastasis.
- Ability to use analgesics and clodronate 1600 mg/day.
Key exclusion criteria (4 listed)
- Hypersensitivity to bisphosphonates.
- Clodronate in previous therapy.
- Concomitant use of other bisphosphonates.
- Serious renal insufficiency.
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 |
|---|---|---|
| Bonefos (Clodronate, BAY94-8393)Patients in regular clinical practice receiving Bonefos according to local drug information | Drug | Group1 |
Primary outcome
Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma
Time frame: 12 months
1 secondary outcome
Decrease in pain measured by VAS (Visual Analogue Scale)
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 6 Apr 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 Bone 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 3 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: finished, as of the sponsor's last update on 6 Apr 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?
Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma (time frame: 12 months). 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 6 Apr 2012.