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A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant 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: Completed

Sponsored by: Hoffmann-La Roche

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


This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant 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 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 and analgesic consumption

Secondary outcome:

AEs and laboratory parameters

Serum creatinine

Karnofsky index


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


Inclusion Criteria:

- female patients, >=18 years of age;

- breast cancer;

- bone metastases;

- moderate to severe pain;

- adequate renal function.

Exclusion Criteria:

- bisphosphonate treatment within 3 weeks of study enrollment.

Locations and Contacts

Ankara 06018, Turkey

Ankara 06230, Turkey

Istanbul 34300, Turkey

Istanbul 34390, Turkey

Izmir 35100, Turkey

Shhiye, Ankara 06100, Turkey

Additional Information

Starting date: January 2008
Last updated: January 20, 2014

Page last updated: August 23, 2015

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