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The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Supportive care | Active | 18 and over | CZOL446GDE21 NCT00375505 |
Trial Description
Summary This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment Eligibility Criteria Inclusion Criteria - Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
- Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
- Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)
- Patient receives adjuvant standard chemoendocrine or endocrine therapy
- Bone density at study entry > -2.5 T-Score
Exclusion Criteria - History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
Other protocol-defined inclusion/exclusion criteria may apply
Trial Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation Novartis | ![](https://webarchive.library.unt.edu/web/20090513100353im_/http://www.cancer.gov/images/spacer.gif) | Study Chair |
Novartis | ![](https://webarchive.library.unt.edu/web/20090513100353im_/http://www.cancer.gov/images/spacer.gif) | Ph: 41 61 324 1111 |
Trial Sites
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Germany |
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Marburg |
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| | Novartis |
Ph: 41 61 324 1111 |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00375505 Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
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