Overview

A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
Female
Summary
This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Diphosphonates
Ibandronic Acid
Criteria
Inclusion Criteria:

- Females at least 18 years of age

- Breast cancer

- Bone metastases

Exclusion Criteria:

- Use of bisphosphonates within the last 3 months

- Prior use of gallium nitrate or metastron

- Severely impaired renal function

- Hypocalcemia or primary hyperparathyroidism

- Central nervous system (CNS) metastases