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临床试验/NCT00809484
NCT00809484已完成不适用

A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.

Hellenic Breast Surgeons Society1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
1

研究概览

简要总结

To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women
  • ER and or PgR positive breast cancer
  • Completed Surgery and =/- chemotherapy

排除标准

  • metastases
  • history of fractures
  • HRT or SERMs
  • Liver or kidney disfunction

研究者

发起方
Hellenic Breast Surgeons Society
申办方类型
Other

研究点 (1)

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