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Trial record 35 of 4293 for:    bone tumors AND NOT metastatic

Bonefos and the Consumption of Analgesics (BICAM)

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ClinicalTrials.gov Identifier: NCT00909142
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : April 6, 2012
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment
Bone Neoplasms Drug: Bonefos (Clodronate, BAY94-8393)

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Study Type : Observational
Actual Enrollment : 149 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Group/Cohort Intervention/treatment
Group1 Drug: Bonefos (Clodronate, BAY94-8393)
Patients in regular clinical practice receiving Bonefos according to local drug information




Primary Outcome Measures :
  1. 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 :
  1. Decrease in pain measured by VAS (Visual Analogue Scale) [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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

Keywords provided by Bayer:
Breast cancer
Prostate cancer
Multiple myeloma

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