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A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain;; Bone Neoplasms;; Neoplasm Metastasis

Intervention: ibandronate [Bondronat] (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Clinical Details

Official title: 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.

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

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

Secondary outcome:

Mean worst pain score over first 7 days

Analgesic consumption

Karnofsky index

AEs, laboratory parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Alexandroupolis, Greece

Athens, Greece

Haidari, Greece

Patras, Greece

Piraeus, Greece

Thessaloniki, Greece

Additional Information


Last updated: March 19, 2008

Page last updated: August 23, 2015

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