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

Phase 2 Completed 251 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2014-09-16
Primary completion: 2018-05-14
Completion: 2018-10-25

Outcome

Met primary endpoint

registry analysis (superiority test); Bimagrumab 700 mg vs Placebo; p <.0001; Treatment Group Ratio (BYM - Placebo) 1.057 (95% CI 1.037 to 1.076); Mixed Models Analysis NCT02152761 ↗

registry analysis (superiority test); Bimagrumab 210 mg vs Placebo; p <.0001; Treatment group rratio (BYM - Placebo) 1.043 (95% CI 1.024 to 1.064); Mixed Models Analysis NCT02152761 ↗

Publications

Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimagrumab	Monoclonal antibody	70 mg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	210 mg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	700 mg	Intravenous