A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 92
- 主要终点
- Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
研究概览
简要总结
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.
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
- Double (Participant, Investigator)
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
- •Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;
排除标准
- •Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
- •Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).
- •Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).
- •Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.
- •Other protocol-defined exclusion criteria may have applied.
研究组 & 干预措施
Zoledronic acid every (q) 4 weeks
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
干预措施: Zoledronic acid (Drug)
Zoledronic acid q 12 weeks
Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
干预措施: Zoledronic acid (Drug)
Zoledronic acid q 12 weeks
Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
干预措施: Placebo (Drug)
Placebo / zoledronic acid
Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
干预措施: Zoledronic acid (Drug)
Placebo / zoledronic acid
Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
时间窗: 52 weeks
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.
次要结局
- Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score(baseline, 52 weeks)
- Time to First Individual Type of SRE(52 weeks)
- Change From Baseline in Urinary N-telopeptide / Creatinine Ratio(baseline, 48 weeks)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase(baseline, 48 weeks)
- Skeletal Morbidity Rate(52 weeks)
- Change From Baseline in Mean Analgesic Score(baseline, 52 weeks)
- Time to First SRE(52 weeks)