- Female patients ≥ 18 years of age
- Confirmed breast cancer with bone metastasis.
- Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses.
- Abnormal kidney function determined by serum creatinine levels.
- Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
- Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
- Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone)
- Known hypersensitivity to Zometa
- Treatment with other investigational drugs within 30 days prior to randomization.
Other protocol-defined exclusion criteria may apply.