Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

Phase 2 Completed 402 enrolled Amgen UCB Pharma · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Timeline

Start: 2009-09-02
Primary completion: 2012-03-06
Completion: 2013-05-10

Publications

Background Bhandari M, Schemitsch EH, Karachalios T, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Miclau T. Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study. J Bone Joint Surg Am. 2020 Aug 19;102(16):1416-1426. doi: 10.2106/JBJS.19.01008.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Romosozumab	Monoclonal antibody	70 mg	Subcutaneous
Subject	Romosozumab	Monoclonal antibody	140 mg	Subcutaneous
Subject	Romosozumab	Monoclonal antibody	210 mg	Subcutaneous

Indications

No indication recorded.