Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

Inclusion Criteria: Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreatedwith Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;

Exclusion Criteria: Abnormal kidney function determined by serum creatinine levels. Current active dentalproblems including: ongoing infection of the teeth or jawbone; current exposed bone in themouth; 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 ofbone). Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 daysprior to randomization. Other protocol-defined exclusion criteria may have applied.