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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 in the 2nd Year of Treatmen

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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.

Gender: Female
Steward Physician(s)
  • Novartis Pharmaceuticals
Facilities
  • Holy Family Hospital - Completed
Trial Interventions
Drug
  • Zoledronic acid
  • Placebo
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis Pharmaceuticals
Phase: Phase 3
Trial ID: NCT00320710
Volunteers:  Not Accepting Healthy Volunteers

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