臨床研究等提出・公開システム

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

Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Undecided

Novartis Pharma K. K.

Novartis Pharma K. K.

+81-120-003-293

completed

Sept. 16, 2015

Interventional

Randomized, Safety/Efficacy Study, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Treatment

treatment purpose

2

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.

Both

Muscle Wasting (Atrophy) After Hip Fracture Surgery

investigational material(s)
Generic name etc : BYM338
INN of investigational material : Bimagrumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Bimagrumab(high dose or low dose) will be administered as intravenous infusion starting on Day 1 until week 52.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Change from baseline in total lean body mass measured by DXA at week 24 [ Time Frame: Baseline, Week 24 ]
Change from baseline to Week 24 in total lean body mass

efficacy
Change from baseline in gait speed at week 24 and week 52[ Time Frame: Baseline, Week 24 and Week 52 ]
Change from baseline to Week 24 and from baseline to Week 52 in gait speed (meters/sec)
efficacy
Change from baseline in short physical performance battery at week 24 and week 52 [ Time Frame: Baseline, Week 24 and Week 52 ]
Change from baseline to Week 24 and from baseline to Week 52 in physical performance as measured by the Short Physical Performance Battery
safety
Safety and Tolerability of bimagrumab assessed by various measures such as adverse events [ Time Frame: 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 ]
Safety and Tolerability assessed by various measures such as adverse events
efficacy
Change from baseline in total lean body mass measured by DXA at week 52 [ Time Frame: Baseline, Week 52 ]
Change from baseline to Week 52 in total lean body mass

-

July. 14, 2014