CClinicalTrials.gg
CompletedNCT00909142BICAMUpdated Apr 6, 2012

Bonefos and the Consumption of Analgesics

An observational study in Bone Neoplasms, sponsored by Bayer. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
149
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Bone Neoplasms

Browse trials for

Keywords

  • Breast cancer
  • Prostate cancer
  • Multiple myeloma
03

In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 149 is above the median of 75 across 93 observational studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Hypersensitivity to bisphosphonates.
  • Clodronate in previous therapy.
  • Concomitant use of other bisphosphonates.
  • Serious renal insufficiency.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
149 participants (actual)

Groups and cohorts

  • Group1

    Drug: Bonefos (Clodronate, BAY94-8393)

Interventions

  • DrugBonefos (Clodronate, BAY94-8393)

    Patients in regular clinical practice receiving Bonefos according to local drug information

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Decrease in pain measured by VAS (Visual Analogue Scale)

    Time frame: 12 months

07

Study locations

1 site
  • Many locations, Czech Republic
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909142
Lead sponsor
Bayer
First posted
May 27, 2009
Start date
Apr 2007
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Apr 6, 2012

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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