check_circleStudy Completed

Bone Neoplasms

Bayer Identifier:

14236

ClinicalTrials.gov Identifier:

NCT00909142

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bonefos and the consumption of analgesics

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Breast cancer or prostate cancer or multiple myeloma.
    - Bone metastasis.
    - Ability to use analgesics and clodronate 1600 mg/day.
  • - Hypersensitivity to bisphosphonates.
    - Clodronate in previous therapy.
    - Concomitant use of other bisphosphonates.
    - Serious renal insufficiency.

Trial summary

Enrollment Goal
149
Trial Dates
April 2007 - February 2009
Phase
N/A
Could I Receive a placebo
No
Products
Bonefos (Clodronate, BAY94-8393)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Czech Republic

Primary Outcome

  • Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No

Secondary Outcome

  • Decrease in pain measured by VAS (Visual Analogue Scale)
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    no

Trial design

Bonefos and the consumption of analgesics. Influence of clodronate on analgesics consumption among patients with bone metastasis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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