NCT00049452已完成3 期
A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer
Herbert Irving Comprehensive Cancer Center5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2001年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Changes in lumbar spine bone mineral density (BMD) at 6 months
研究概览
简要总结
RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer.
详细描述
OBJECTIVES:
- Compare the changes in bone mineral density (BMD) and bone turnover that occur in premenopausal women with resected early stage breast cancer during and after 6 months of adjuvant chemotherapy.
- Determine the factors that predict bone loss during chemotherapy, particularly induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline BMD, in these patients.
- Determine whether zoledronate prevents bone loss in these patients when given during and after adjuvant chemotherapy.
- Determine the effect of zoledronate on markers of bone turnover in these patients during and after adjuvant chemotherapy.
- Determine whether the effect on markers of bone turnover predicts response to zoledronate in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative), progesterone receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1.
- Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment repeats every 3 months for up to 4 courses in the absence of disease progression. Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.
Quality of life is assessed at baseline and at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of localized breast cancer
- •Stage I or II (T1-3, N0-2, M0)
- •Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration
- •Hormone receptor status:
- •Estrogen receptor and progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Premenopausal or perimenopausal
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Creatinine less than 2 mg/dL
- •No T score of less than 2.0 on bone mineral density (BMD)
- •No fragility fracture
- •No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 1 month since prior calcitonin
- •At least 12 months since prior bisphosphonates given for more than 1 month duration
- •No concurrent fluoride therapy (10 mg/day or more)
- •No concurrent enrollment in another experimental drug study
排除标准
- 未提供
结局指标
主要结局
Changes in lumbar spine bone mineral density (BMD) at 6 months
次要结局
- Changes in lumbar spine BMD at 12 and 24 months
- Total hip and femoral neck BMD at 6, 12, and 24 months
- Serum markers of bone turnover (osteocalcin, bone-specific alkaline phosphatase, and cross-linked C-telopeptide of type 1 collagen levels) measured every 6 weeks for 6 months, and at 9 and 12 months
- Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months
- Treatment costs
研究者
研究点 (5)
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