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

Novartis

Status and phase: Completed; Phase 2

Conditions: Muscle Wasting (Atrophy) After Hip Fracture Surgery

Treatments: Other: placebo; Drug: bimagrumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02152761

CBYM338D2201

2013-003439-31 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 251 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Must not have history of any other lower limb fractures in the past 6 months; Must not have certain cardiovascular conditions; 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 4 patient groups, including a placebo group

bimagrumab 700 mg

Experimental group

Description:

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

Treatment:

Drug: bimagrumab

bimagrumab 210 mg

Experimental group

Description:

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

Treatment:

Drug: bimagrumab

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

Bimagrumab 70 mg

Experimental group

Description:

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

Treatment:

Drug: bimagrumab