Efficacy and Safety of Zoledronic Acid ( Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Bone Cancer



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/30/-0001
Start Date:February 2006
End Date:September 2013
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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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


Clinical trial in breast cancer patients with bone metastases pretreated with zoledronic
acid. Looking at the effectiveness 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.


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 apply.
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7710 Wolf River Circle
Memphis, Tennessee 38138
901-685-5969
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5802 State Road 54
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305 1st Avenue # Dazian 7
New York, New York 10003
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107 Longwood Avenue
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