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

Conditions

• Muscle Wasting (Atrophy) After Hip Fracture Surgery

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bimagrumab — DRUG
  Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
• placebo — OTHER
  Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.

Study Details

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

Key Dates

Start date

Sep 16, 2014

Status verified

Aug 2020

Primary completion

May 14, 2018

Completion

Oct 25, 2018

Study Design

Enrollment

251 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: bimagrumab 700 mg
  Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20
• Experimental: bimagrumab 210 mg
  Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20
• Placebo Comparator: placebo
  Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20
• Experimental: Bimagrumab 70 mg
  Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20

Primary Outcome Measure

Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 [ Time Frame: baseline, weeks 12 and 24 ]

Locations (6)

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