Bonefos and the Consumption of Analgesics (BICAM)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00909142
First received: May 25, 2009
Last updated: April 5, 2012
Last verified: April 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in pain measured by VAS (Visual Analogue Scale) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909142

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

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00909142     History of Changes
Other Study ID Numbers: 14236, Bonefos
Study First Received: May 25, 2009
Last Updated: April 5, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Bayer:
Breast cancer
Prostate cancer
Multiple myeloma

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

ClinicalTrials.gov processed this record on August 28, 2014