An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,065
- 试验地点
- 2
- 主要终点
- Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Upfront 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.
干预措施: Zoledronic acid (Drug)
Upfront 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.
干预措施: Letrozole (Drug)
Delayed Zoledronic Acid
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.
干预措施: Zoledronic acid (Drug)
Delayed Zoledronic Acid
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.
干预措施: Letrozole (Drug)
结局指标
主要结局
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
时间窗: Baseline, 12 months
Bone Mineral Density (g/cm\^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
次要结局
- Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.(Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.)
- Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.(Baseline, 5 years.)
- Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.(Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.)
- Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline(Baseline,3 years)