We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bonefos and the Consumption of Analgesics (BICAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909142
First Posted: May 27, 2009
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909142


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

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00909142     History of Changes
Other Study ID Numbers: 14236
Bonefos
First Submitted: May 25, 2009
First Posted: May 27, 2009
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Bayer:
Breast cancer
Prostate cancer
Multiple myeloma

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Analgesics
Clodronic Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bone Density Conservation Agents