The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 1
- 主要终点
- Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
研究概览
简要总结
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-IIIa breast cancer
- •Postmenopausal
- •Recent surgery for breast cancer
排除标准
- •Metastatic disease
- •Invasive bilateral disease
- •Clinical or radiological evidence of existing fracture in spine or hip
- •Other protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
Upfront Zoledronic Acid
Zoledronic 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
干预措施: Zoledronic acid (Drug)
Upfront Zoledronic Acid
Zoledronic 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
干预措施: Letrozole (Drug)
Delayed Zoledronic Acid
Zoledronic 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
干预措施: Zoledronic acid (Drug)
Delayed Zoledronic Acid
Zoledronic 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
干预措施: Letrozole (Drug)
结局指标
主要结局
Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
时间窗: From Baseline - 12 months
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100.
次要结局
- Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years(From Baseline to Year 2, Year 3, Year 4, Year 5)
- Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5(From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5)
- Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5(From baseline to Year 1, Year 2, Year 3, Year 4, Year 5)
- Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3(Year 3)