A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
研究概览
简要总结
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women defined as Postmenopausal
- •Histologically proven operable invasive breast cancer
- •Hormone-receptor-positive breast cancer
排除标准
- •Clinical evidence of metastatic disease
- •Bilateral hip fractures or bilateral hip prosthesis
- •Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
- •Malabsorption syndrome
研究组 & 干预措施
1
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
干预措施: Anastrozole (Drug)
1
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
干预措施: Risedronate Sodium (Drug)
2
Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
干预措施: Anastrozole (Drug)
2
Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
干预措施: Risedronate Sodium (Drug)
3
Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
干预措施: Anastrozole (Drug)
3
Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
干预措施: Risedronate Sodium (Drug)
结局指标
主要结局
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
时间窗: Assessed at 12 months
次要结局
- Change from baseline in total hip BMD(Assessed at 12 and 24 months)
- Change from baseline in lumbar spine (L1-L4) BMD(Assessed at 24 months)
- Change from baseline in bone formation markers(Assessed at 6 and12 months)
- Change from baseline in bone resorption and formation markers(Assessed at 6 and 12 months)
- Change from baseline in LDL-cholesterol(Assessed at 12 months)
- Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides(Assessed at 3, 6 and 12 months)