56-week, Randomized, Multicenter, Double Blind, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

Novartis Pharma K.K.1 个研究点目标入组 210 人开始时间: 待定最近更新: 2020年2月12日

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis Pharma K.K.
入组人数: 210
试验地点: 1
主要终点: Change from baseline in total lean body mass measured by DXA at week 24

暂无简介。

研究类型: Interventional
干预模型: Randomized, Safety/Efficacy Study, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Treatment
主要目的: Treatment Purpose

•Must have X-ray confirmed successful hip fracture repair; must have completed surgical wound healing; ability to walk a specified distance with or without a walking aid; must weigh at least 35 kg.

•Must not have history of fracture of the same hip; Must not have history of any other lower limb fractures in the past 6 months; Must meet cardiovascular requirements; Must not have a chronic active infection (e.g. HIV, hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at least 3 months in the past year; Other protocol-defined inclusion and exclusion criteria may apply.

Change from baseline in total lean body mass measured by DXA at week 24

时间窗: Baseline, Week 24

Change from baseline to Week 24 in total lean body mass

Change from baseline in gait speed at week 24 and week 52(Baseline, Week 24 and Week 52)
Change from baseline in short physical performance battery at week 24 and week 52(Baseline, Week 24 and Week 52)
Safety and Tolerability of bimagrumab assessed by various measures such as adverse events(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56)
Change from baseline in total lean body mass measured by DXA at week 52(Baseline, Week 52)

发起方

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