A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 195
- 主要终点
- Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry
研究概览
简要总结
RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss.
PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
详细描述
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years.
Patients are followed for 1 year. A summary of study goals is listed below.
Goals:
- To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
- To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins.
- To evaluate the relationship of current climacteric symptoms, menstrual and reproductive history, and chemotherapy regimen with ovarian failure (permanent cessation of menses) in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
- To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
calcium carbonate, vitamin D and risedronate
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
干预措施: calcium carbonate (Dietary Supplement)
calcium carbonate, vitamin D and risedronate
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
干预措施: vitamin D (Dietary Supplement)
calcium carbonate, vitamin D and risedronate
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
干预措施: risedronate sodium (Drug)
calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.
干预措施: calcium carbonate (Dietary Supplement)
calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.
干预措施: vitamin D (Dietary Supplement)
calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.
干预措施: placebo (Other)
结局指标
主要结局
Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry
时间窗: 1 year post study entry
次要结局
- Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry(1 year post study entry)
- Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry(1 year post study entry)
- Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry(1 year post study entry)
- Incidence of a 5% difference in intra-patient BMD scores at baseline(Baseline)
- Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months(Up to 6 months)
- Frequency and severity of toxicity as measured by NCI CTC version 2.0(Up to 1 year post study treatment)
- Menopausal symptoms as measured by the Greene Climacteric Scale (GCS) at baseline, monthly during chemotherapy, at 6 months, 1 year, and 2 years after study entry(Up to 2 years post study entry)
- Association of baseline serum estradiol levels with permanent cessation of menses(Baseline)
- Relationship between the subscales of the GCS (psychological, vasomotor, somatic and sexual) with type of chemotherapy, duration of chemotherapy, and menstrual cycle changes(Up to 2 years post study entry)