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

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

Intervention: ibandronate [Bondronat] (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

Overall contact:
Please reference Study ID Number: RLI_ML20684, Phone: 973-235-5000

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.

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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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.

Criteria:

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.

Please reference Study ID Number: RLI_ML20684, Phone: 973-235-5000

ISTANBUL 34300, Turkey; Recruiting

IZMIR 35100, Turkey; Recruiting

ANKARA 06100, Turkey; Recruiting

ANKARA 06018, Turkey; Recruiting

ISTANBUL 34390, Turkey; Recruiting

Starting date: October 2007
Ending date: January 2009
Last updated: October 15, 2008