Bone Neoplasms Clinical Trial
— BICAMOfficial title:
Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis
Verified date | April 2012 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: State Institute for Drug Control |
Study type | Observational |
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.
Status | Completed |
Enrollment | 149 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Breast cancer or prostate cancer or multiple myeloma. - Bone metastasis. - Ability to use analgesics and clodronate 1600 mg/day. Exclusion Criteria: - Hypersensitivity to bisphosphonates. - Clodronate in previous therapy. - Concomitant use of other bisphosphonates. - Serious renal insufficiency. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Czech Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma | 12 months | No | |
Secondary | Decrease in pain measured by VAS (Visual Analogue Scale) | 12 months | No |
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