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Bonefos and the Consumption of Analgesics (BICAM)

This study has been completed.
Information provided by:
Bayer Identifier:
First received: May 25, 2009
Last updated: April 5, 2012
Last verified: April 2012
The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.

Condition Intervention
Bone Neoplasms Drug: Bonefos (Clodronate, BAY94-8393)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Decrease in pain measured by VAS (Visual Analogue Scale) [ Time Frame: 12 months ]

Enrollment: 149
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group1 Drug: Bonefos (Clodronate, BAY94-8393)
Patients in regular clinical practice receiving Bonefos according to local drug information


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Random sample of cancer patients visting oncologist or urologist ambulance who are suitable for standard clodronate treatment.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00909142

Czech Republic
Many locations, Czech Republic
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG Identifier: NCT00909142     History of Changes
Other Study ID Numbers: 14236
Study First Received: May 25, 2009
Last Updated: April 5, 2012

Keywords provided by Bayer:
Breast cancer
Prostate cancer
Multiple myeloma

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Clodronic Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on July 21, 2017