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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


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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