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 |
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.
We found this trial at
159
sites
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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2279 45th Street
Sacramento, California 95817
Sacramento, California 95817
(916) 734-5800
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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Atlanta, Georgia 30322
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Cincinnati, Ohio 45238
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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