A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures

Authors

Emil H. Schemitsch, Western University
Theodore Miclau, University of California, San Francisco
Theofilos Karachalios, Panepistimio Thesalias
Lauren L. Nowak, Western University
Parag Sancheti, Sancheti Institute of Orthopaedics and Rehabilitation
Rudolf W. Poolman, Our Lady Hospital - Amsterdam
John Caminis, Sanofi S.A.
Nadia Daizadeh, Amgen Incorporated
Ricardo E. Dent-Acosta, Amgen Incorporated
Ogo Egbuna, Amgen Incorporated
Arkadi Chines, Amgen Incorporated
Judy Maddox, Amgen Incorporated
Andreas Grauer, Amgen Incorporated
Mohit Bhandari, McMaster University

Document Type

Article

Publication Date

4-15-2020

Journal

Journal of Bone and Joint Surgery - American Volume

Volume

102

Issue

8

First Page

693

Last Page

702

URL with Digital Object Identifier

10.2106/JBJS.19.00790

Abstract

© 2020 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved. Background:Romosozumab is a bone-forming antibody that increases bone formation and decreases bone resorption. We conducted a double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on the clinical outcomes of open reduction and internal fixation of intertrochanteric or femoral neck hip fractures.Methods:Patients (55 to 94 years old) were randomized 2:3:3:3 to receive 3 subcutaneous injections of romosozumab (70, 140, or 210 mg) or a placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary end point was the difference in the mean timed "Up & Go" (TUG) score over weeks 6 to 20 for romosozumab versus placebo. Additional end points included the time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH).Results:A total of 332 patients were randomized: 243 to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 to receive a placebo. Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198). The median time to radiographic evidence of healing was 16.4 to 16.9 weeks across treatment groups. The RUSH scores improved over time across treatment groups but did not differ significantly between the romosozumab and placebo groups. The overall safety and tolerability profile of romosozumab was comparable with that of the placebo.Conclusions:Romosozumab did not improve the fracture-healing-related clinical and radiographic outcomes in the study population.

Notes

Article is freely available from the journal