EUCTR2006-000849-19-IT进行中（未招募）不适用
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy from Alendronate to Denosumab AMG 162 in Postmenopausal Women with Low Bone Mineral Density - STAND
AMGEN S.P.A.0 个研究点目标入组 500 人开始时间: 2007年1月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Ambulatory postmenopausal women, with BMD g/cm2 values that correspond to a T-score 8804; -2.0 and 8805;-4.0 at the lumbar spine or total hip. Subjects must have received alendronate treatment of 70 mg/wk or equivalent for at least 6 months prior to screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •unstable hyper or hypothyroidism; hypo or hyperparathyroidism; epatic or renal impairment; hypo or hypercalcemia; acute gastric or duodenal ulcer or history of gastrointestinal bleed; reumatoid arthritis, Paget s disease, Cushing s disease, cirrhosis of the liver, hyperprolactinemia, positive test for HIV, hepatitis C or B, malignancies within the last 5 years, malabsorption syndrome.
研究者
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