NCT00909142

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

May 25, 2009

Last Update Submit

April 5, 2012

Conditions

Bone Neoplasms

Keywords

Breast cancerProstate cancerMultiple myeloma

Outcome Measures

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

    12 months

Secondary Outcomes (1)

  • Decrease in pain measured by VAS (Visual Analogue Scale)

    12 months

Study Arms (1)

Group1

Drug: Bonefos (Clodronate, BAY94-8393)

Interventions

Bonefos (Clodronate, BAY94-8393)DRUG

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

Group1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random sample of cancer patients visting oncologist or urologist ambulance who are suitable for standard clodronate treatment.

You may qualify if:

  • Breast cancer or prostate cancer or multiple myeloma.
  • Bone metastasis.
  • Ability to use analgesics and clodronate 1600 mg/day.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Czechia

Location

MeSH Terms

Conditions

Bone NeoplasmsBreast NeoplasmsProstatic NeoplasmsMultiple Myeloma

Interventions

Clodronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2009

First Posted

May 27, 2009

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

CZ(1)