A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

Summary

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

Timeline

Start

2017-09-11

Primary completion

2019-10-01

Completion

2020-11-12

Outcome

Mixed primary results

paper There were no changes in radial trabecula vBMD (p>05). PMID 39012717 ↗

paper At 12 mo, there was a significant increase in mean (SE) failure load in the 20 mg/kg group (3.17% [1.26%]) PMID 39012717 ↗

registry analysis (superiority test); Setrusumab 20 mg/kg (Blinded); p = 0.006; ANCOVA; NCT03118570 ↗

registry analysis (superiority test); Setrusumab 20 mg/kg (Blinded); p = 0.011; ANCOVA; NCT03118570 ↗

registry analysis (superiority test); Setrusumab 8 mg/kg (Blinded); p = 0.047; ANCOVA; NCT03118570 ↗

Publications

• Glorieux FH, Langdahl B, Chapurlat R, De Beur SJ, Sutton VR, Poole KES, Dahir KM, Orwoll ES, Willie BM, Mikolajewicz N, Zimmermann E, Hosseinitabatabaei S, Ominsky MS, Saville C, Clancy J, MacKinnon A, Mistry A, Javaid MK. Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study. J Bone Miner Res. 2024 Sep 2;39(9):1215-1228. doi: 10.1093/jbmr/zjae112.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setrusumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Setrusumab	Monoclonal antibody	8 mg/kg	Intravenous
Subject	Setrusumab	Monoclonal antibody	20 mg/kg	Intravenous
Background	Zoledronic acid	Other / unclassified	—	—

Indications