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

Roche

Status and phase: Completed; Phase 2

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Treatments: Drug: ibandronate [Bondronat]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502736

ML20684

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ibandronate [Bondronat]