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A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer

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

- Known hypersensitivity to Zometa

- Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who experience at least one Skeletal Related Event (SRE) during the study period (SRE rate)

Outcome Time Frame:

during the study period

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • zoledronic acid
  • bone metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



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