Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

Phase 2 Completed 332 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

Timeline

Start: 2010-06-20
Primary completion: 2012-06-30
Completion: 2013-05-10

Publications

Background Schemitsch EH, Miclau T, Karachalios T, Nowak LL, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Maddox J, Grauer A, Bhandari M. A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures. J Bone Joint Surg Am. 2020 Apr 15;102(8):693-702. doi: 10.2106/JBJS.19.00790.

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.