Denosumab, a new pharmacotherapy option for postmenopausal osteoporosis

Abstract

Background:

According to the 2010 Osteoporosis Canada Clinical Practice Guidelines, denosumab is a first-line option for the pharmacological management of postmenopausal osteoporosis (PMO), along with several therapeutics that may be more familiar to family practice doctors: bisphosphonates, raloxifene, teriparatide, and hormone therapy. Denosumab is indicated for postmenopausal patients at high risk for fracture or others who have failed, or are intolerant to, other osteoporosis therapies.

Scope:

We undertook a review of the efficacy and safety of denosumab in PMO, searching the English-language literature on this drug via PubMed queries as of July 2012.

Findings:

Although established treatments reduce fracture risk among osteoporotic postmenopausal women in trials, their effectiveness in clinical practice is limited by patient adherence. Twice-yearly denosumab treatment is associated with markedly improved bone mineral density (BMD) and cortical and trabecular bone strength, and significantly reduced osteoporotic fracture. Inhibition of bone resorption is fully reversible following discontinuation. Placebo-controlled and open-label extension studies showed similar adverse event (AE) and serious AE rates, relative to placebo, over up to 5 years. Data indicate a potential advantage of denosumab over the bisphosphonate alendronate for BMD and patient adherence and preference.

Conclusion:

Owing to its efficacy, safety, and potential to improve adherence rates, denosumab is an appropriate first-line pharmacologic option for PMO management.

Key words::

• Bisphosphonates
• Bone mineral density
• Denosumab
• Fracture
• Osteoporosis
• Postmenopausal

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Corrigendum

Transparency

Declaration of funding

Amgen Canada supported this project from its inception. The opinions and analysis presented here are solely those of the authors.

Declaration of financial/other relationships

R.J. is an Advisory board member for and has received speaker honoraria and/or clinical research grants from: Amgen, Eli Lilly, Novartis, Warner Chilcott, Merck, GSK, Astra Zeneca, Osteoporosis Canada, International Osteoporosis Foundation. A.K. has received consulting fees, honoraria or research grants from Amgen, Alliance, Merck, Novartis, Eli Lilly, and NPS. D.N. has participated in National Advisory Boards and Speakers Bureau for Amgen Canada, Merck and Novartis and is a member of the Executive Editorial Board for Guidelines and Advisory Board for Primary Care Research with Amgen/Osteoporosis Canada. M.S. has received speaker honoraria from and is an advisory board member for Amgen, Pfizer, Merck, NovoNordisk, Bayer, GSK, Warner Chilcott, Astra-Zeneca and Eli Lilly.

Acknowledgments

Writing assistance was provided by John Ashkenas PhD (SCRIPT, Toronto Ontario) and Peter Janiszewski PhD (SCRIPT, Toronto Ontario), funded by Amgen Canada.