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Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1
year with a standard zoledronic acid regimen. Looking at the continued effectiveness and
safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year.
This study is prospective, double-blind, stratified, multi-center, and two-arm.
Ages:18 and older
Inclusion Criteria: 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; Exclusion Criteria: 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 have applied.
Sponsor: Novartis Pharmaceuticals
Phase: Phase 3
Trial ID: NCT00320710
Not Accepting Healthy Volunteers