Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Bone Loss, Breast Cancer
About this trial
This is an interventional treatment trial for Bone Loss focused on measuring Bone Loss, Osteopenia, Breast cancer, letrozole, zoledronic acid, postmenopausal
Eligibility Criteria
Inclusion Criteria: Stage I-IIIa breast cancer Postmenopausal or recently postmenopausal Recent surgery for breast cancer Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status No prior treatment with letrozole Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Metastatic disease Invasive bilateral disease Clinical or radiological evidence of existing fracture in spine or hip Prior treatment with IV bisphosphonates in the past 12 months Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation) Use of Tibolone within 6 months Prior use of parathyroid hormone for more than 1 week Previous or concomitant malignancy Abnormal renal function History of disease effecting bone metabolism Other protocol-defined exclusion criteria may apply.
Sites / Locations
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- Ratchathew
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Upfront Zoledronic Acid
Delayed Zoledronic Acid
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.