A Phase II Prospective Pilot Study Evaluating Efficacy of Intravenous Zoledronic Acid Prophylaxis for Prevention of Aromatase Inhibitor Associated Musculoskeletal Symptoms: ZAP-AIMSS Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
研究概览
简要总结
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer.
PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.
详细描述
PRIMARY OBJECTIVES:
I. Percentage of women experiencing aromatase inhibitor associated musculoskeletal symptoms (AIMSS) at 1, 3, 6, and 12 months after bisphosphonate therapy, as compared to historical controls.
II. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score and 1, 3, 6 and 12 months, from baseline, among those receiving bisphosphonate, as compared to historical controls.
SECONDARY OBJECTIVES:
I. Change in pain scores on visual analog scale (VAS) at 1, 3, 6 and 12 months, from baseline, compared to historical controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I - IV Zoledronic Acid Prophylaxis
Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: letrozole (Drug)
Arm I - IV Zoledronic Acid Prophylaxis
Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Number of Participants With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
时间窗: 12 months
次要结局
- AIMSS as Determined by Health Assessment Questionnaire Disability Index (HAQ-DI) Score(Baseline, 1 month, 3 months, 6 months, 12 months)
- AIMSS as Determined by Visual Analog Scale (VAS) Score(Baseline, 1 month, 3 months, 6 months, 12 months)
- Number of Participants Who Discontinue or Change Aromatase Inhibitor (AI) Therapy(12 months)