Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

Novartis Pharmaceuticals0 个研究点目标入组 160 人开始时间: 2005年3月1日最近更新: 2011年11月2日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis Pharmaceuticals
入组人数: 160
主要终点: Change of lumbar spine(L1-L4)BMD at 12 months

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.

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

入排标准

年龄范围: 50 Years 至 75 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Low spine Bone Mineral Density
•0 to 1 prevalent fracture in non lumber spine

排除标准

•History or presence of any bone disease other than osteopenia /osteoporosis
•Previous treatment with other anti-osteoporosis agent(Wash out required)
•Evidence of vitamin D deficiency
•Other protocol-defined inclusion/exclusion criteria may apply.

结局指标

主要结局

Change of lumbar spine(L1-L4)BMD at 12 months

Safety of 12 month treatment

次要结局

Change of BMD of lumbar spine(L1-L4,L2-L4)、total hip, femoral neck, forearm and total body at 3, 6, 9 and 12 months
Change of Bone markers(Serum CTX,P1NP, OC, BSAP and urinary NTX, DPyr at 1,3,6,9 and 12 months
Plasma concentration of AAE581 and AEE325 at 1,3,6,9 and 12 months

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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