Bonefos and the Consumption of Analgesics

Bone Neoplasms Clinical Trial

— BICAM  

Official title:

Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909142
• Other study ID #: 14236
• Secondary ID: Bonefos
• Status: Completed
• Phase: N/A
• First received: May 25, 2009
• Last updated: April 5, 2012
• Start date: April 2007
• Est. completion date: February 2009

Study information

• 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

Clinical Trial Summary

The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Neoplasms

Intervention

Drug:
• Bonefos (Clodronate, BAY94-8393)
Patients in regular clinical practice receiving Bonefos according to local drug information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Czech Republic, 

Outcome

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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