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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00375505 |
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
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss |
Estimated Enrollment: | 70 |
Study Start Date: | September 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CZOL446GDE21 |
Study First Received: | September 11, 2006 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00375505 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Breast Cancer Premenopausal Bone mineral density Cancer therapy induced bone loss zoledronic acid |
Diphosphonates Zoledronic acid Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |