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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00050011 |
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start ( based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIa postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.
Condition | Intervention | Phase |
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Breast Neoplasms Osteoporosis |
Drug: Zoledronic Acid and Letrozole |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy |
Estimated Enrollment: | 602 |
Study Start Date: | July 2002 |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Postmenopausal status defined by one of the following :
Adequately diagnosed and treated breast cancer defined as:
Hormone receptor positive defined as:
The date of randomization must not be more than the following:
Exclusion criteria
Additional Exclusion Criteria for Spine DXA
Additional protocol-defined inclusion/exclusion criteria may apply.
Principal Investigator: | Steven Papish, MD | Morristown Memorial Hospital |
Study ID Numbers: | CZOL446EUS32 |
Study First Received: | November 18, 2002 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00050011 |
Health Authority: | United States: Food and Drug Administration |
cancer-treatment related bone loss postmenopausal women breast cancer hormone receptor positive breast cancer adjuvant therapy hormonal therapy |
bone loss bisphosphonates ZFAST Letrozole Zoledronic Acid US32 |
Diphosphonates Zoledronic acid Progesterone Musculoskeletal Diseases Skin Diseases Osteoporosis |
Breast Neoplasms Letrozole Bone Diseases, Metabolic Bone Diseases Breast Diseases |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Bone Density Conservation Agents Hormones |
Pharmacologic Actions Neoplasms Neoplasms by Site Progestins Therapeutic Uses Aromatase Inhibitors |