Denosumab for the treatment of osteoporosis.

Journal Article (Journal Article;Review)

INTRODUCTION: Low trauma fractures due to osteoporosis are a major health concern worldwide. Despite the availability of many therapeutic compounds to reduce fracture risk, osteoporosis remains undertreated and the burden of osteoporotic fractures remains high. Denosumab is a novel agent that acts to reduce bone turnover, improve bone mineral density, and reduce fracture risk, offering a favorable efficacy and safety profile. AREAS COVERED: This review covers the pharmacology and major clinical trials with extension/post-marketing follow-up, including trials for all FDA-approved indications of denosumab to date. EXPERT OPINION: Denosumab is an efficacious and safe osteoporosis treatment option, with current data from up to 8 years of continued use showing continued improvement in bone density with sustained fracture risk reduction. Safety profiles overall are similar to placebo, with no new safety concerns in extension trials, though a theoretical increased risk of infection exists with RANKL inhibition. Future considerations include safety of prolonged treatment beyond 8 years, and efficacy/fracture risk after discontinuation or with non-adherence, given the characteristic pharmacodynamic profile of denosumab.

Full Text

Duke Authors

Cited Authors

  • Zaheer, S; LeBoff, M; Lewiecki, EM

Published Date

  • March 2015

Published In

Volume / Issue

  • 11 / 3

Start / End Page

  • 461 - 470

PubMed ID

  • 25614274

Pubmed Central ID

  • PMC4480604

Electronic International Standard Serial Number (EISSN)

  • 1744-7607

Digital Object Identifier (DOI)

  • 10.1517/17425255.2015.1000860


  • eng

Conference Location

  • England