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An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain;, Bone Neoplasms;, Neoplasm Metastasis

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Trial Information

An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.


Inclusion Criteria:



- adult patients, >=18 years of age;

- breast cancer;

- bone metastases;

- mean worst pain score >=4 during 3 day baseline period;

- stable dose of analgesics over a 3 day baseline period;

- adequate renal function.

Exclusion Criteria:

- bisphosphonate treatment within 3 weeks of study enrollment;

- a change in antineoplastic treatment within 6 weeks of study enrollment;

- bone radiation within 2 weeks of study enrollment;

- active infection.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption

Outcome Time Frame:

Days 5 - 7

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Greece: E.O.F. (National drug organization)

Study ID:

ML20247

NCT ID:

NCT00478270

Start Date:

Completion Date:

January 2008

Related Keywords:

  • Pain;
  • Bone Neoplasms;
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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