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.
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 bisphosphonatealendronate 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.