Romosozumab for the treatment of osteoporosis

ABSTRACT

Introduction: Sclerostin, a glycoprotein produced primarily by osteocytes, blocks the canonical Wnt signaling bone formation pathway. Romosozumab is a humanized monoclonal antibody to sclerostin that binds to sclerostin, permitting the engagement of Wnt ligands with their co-receptors, resulting in an increase in bone formation and bone mineral density (BMD). Clinical studies with romosozumab have shown dramatic improvements in BMD at the spine and hip. Romosozumab is associated with improvement in bone strength through mechanisms that include increases in bone formation and, different from classical osteoanabolic agents, suppression of bone resorption.

Areas covered: Herein, the authors highlight the available data on romosozumab for the treatment of osteoporosis. This includes the latest data on the efficacy, pharmacokinetics and pharmacodynamics as well as safety and tolerability data.

Expert opinion: Monthly subcutaneous dosing of romosozumab reduces the risk of vertebral and clinical fractures in women with postmenopausal osteoporosis, with a favorable balance of benefits and risks. Romosozumab is a promising emerging anabolic agent with a novel mechanism of action that may expand the options for treating osteoporotic patients at high risk of fracture.

KEYWORDS:

• Anabolic
• bone mineral density
• fracture
• monoclonal antibody
• osteoporosis
• romosozumab
• sclerostin

Declaration of interest

EM Lewiecki has received institutional grant/research support from Amgen, Merck, and Eli Lilly and Company; he has served on scientific advisory boards for Amgen, Merck, Lilly, Radius, AgNovos Healthcare, Alexion, Shire, and AbbVie; he serves on the speakers’ bureau for Shire. JP Bilezikian is a consultant for Amgen, Radius, Lilly, and Merck and receives research support from Shire. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This manuscript has not been funded.