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

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 intertrocha...

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Autores principales: Schemitsch, Emil H., Miclau, Theodore, Karachalios, Theofilos, Nowak, Lauren L., Sancheti, Parag, Poolman, Rudolf W., Caminis, John, Daizadeh, Nadia, Dent-Acosta, Ricardo E., Egbuna, Ogo, Chines, Arkadi, Maddox, Judy, Grauer, Andreas, Bhandari, Mohit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Journal of Bone and Joint Surgery, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508283/
https://www.ncbi.nlm.nih.gov/pubmed/31977817
http://dx.doi.org/10.2106/JBJS.19.00790
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author Schemitsch, Emil H.
Miclau, Theodore
Karachalios, Theofilos
Nowak, Lauren L.
Sancheti, Parag
Poolman, Rudolf W.
Caminis, John
Daizadeh, Nadia
Dent-Acosta, Ricardo E.
Egbuna, Ogo
Chines, Arkadi
Maddox, Judy
Grauer, Andreas
Bhandari, Mohit
author_facet Schemitsch, Emil H.
Miclau, Theodore
Karachalios, Theofilos
Nowak, Lauren L.
Sancheti, Parag
Poolman, Rudolf W.
Caminis, John
Daizadeh, Nadia
Dent-Acosta, Ricardo E.
Egbuna, Ogo
Chines, Arkadi
Maddox, Judy
Grauer, Andreas
Bhandari, Mohit
author_sort Schemitsch, Emil H.
collection PubMed
description 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. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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spelling pubmed-75082832020-09-24 A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures Schemitsch, Emil H. Miclau, Theodore Karachalios, Theofilos Nowak, Lauren L. Sancheti, Parag Poolman, Rudolf W. Caminis, John Daizadeh, Nadia Dent-Acosta, Ricardo E. Egbuna, Ogo Chines, Arkadi Maddox, Judy Grauer, Andreas Bhandari, Mohit J Bone Joint Surg Am Scientific Articles 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. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Journal of Bone and Joint Surgery, Inc. 2020-04-15 2020-01-22 /pmc/articles/PMC7508283/ /pubmed/31977817 http://dx.doi.org/10.2106/JBJS.19.00790 Text en Copyright © 2020 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Scientific Articles
Schemitsch, Emil H.
Miclau, Theodore
Karachalios, Theofilos
Nowak, Lauren L.
Sancheti, Parag
Poolman, Rudolf W.
Caminis, John
Daizadeh, Nadia
Dent-Acosta, Ricardo E.
Egbuna, Ogo
Chines, Arkadi
Maddox, Judy
Grauer, Andreas
Bhandari, Mohit
A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title_full A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title_fullStr A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title_full_unstemmed A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title_short A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures
title_sort randomized, placebo-controlled study of romosozumab for the treatment of hip fractures
topic Scientific Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508283/
https://www.ncbi.nlm.nih.gov/pubmed/31977817
http://dx.doi.org/10.2106/JBJS.19.00790
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