Bone health

Romosozumab included in new guideline recommendations for severe osteoporosis

The bone anabolic agent romosozumab is now recommended as first line treatment for postmenopausal women with severe osteoporosis in an update to Endocrine Society guidelines.

The drug “should be considered as a first-line therapy in patients with multiple vertebral fractures or hip fracture and BMD in the osteoporotic range,” according to the update published in the Journal of Clinical Endocrinology and Metabolism.

“This agent also could be considered in individuals who have failed antiresorptive treatments,” the new guideline recommends.

According to the guidelines Writing Committee the update to the 2019 Endocrine Society guidelines was done in response to the recent approval of romosozumab by regulatory agencies such as the US FDA and European Medicines Agency. Romosozumab is licensed in Australia as Evenity (Amgen).

The drug is a monoclonal antibody targeting sclerostin which the guidelines says has a more rapid effect on bone than alternatives such as teriparatide. The guidelines note the treatment course of monthly injections is usually 12 months for romosozumab, rather than the 18- to 24-month course for teriparatide, as the anabolic effect is more rapid.

However the guidelines also acknowledge the black box warning in the US for major adverse cardiovascular events with romosozumab. Therefore, women at high risk of cardiovascular disease and stroke should not be considered for romosozumab pending further studies on cardiovascular risk associated with this treatment. High risk includes prior myocardial infarction or stroke.

A second update recommends that after completing a course of romosozumab, women should receive treatment with antiresorptive osteoporosis therapies to maintain bone mineral density gains and reduce fracture risk.

At its March 2020 meeting the Pharmaceutical Benefits Advisory Committee (PBAC) is to re-consider an application for romosozumab to be PBS listed for treatment patients with severe osteoporosis, similar to teriparatide. A previous application for PBS listing was rejected in 2018 “due to uncertainties in the clinical claims and the financial estimates and concerns regarding the safety profile.”

The PBAC also expressed concern about potential ‘leakage’ of romosozumab use into the broader first-line setting.

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