December 01, 2019

New osteoporosis drug for women at risk of fractures

Postmenopausal women who have bone-thinning osteoporosis may be at lower risk of fracture if they take a newly approved drug. The Food and Drug Administration (FDA) approved romosozumab (Evenity) in April 2019 based on results of two large studies of women with postmenopausal osteoporosis.

The studies found that women who recieved romosozumab for a year had a dramatically reduced risk of breaking a bone in the spine and hip during the two years of the study period. Romosozumab was given for a year in monthly injections under the skin. To maintain bone gain from romosozumab, women continued osteoporosis treatment with different osteoporosis medications.

One study found the drug lowered the risk of fracture by 73%, the other study by 50%. The studies also showed that romosozumab, unlike other drugs commonly used to treat osteoporosis, helps regrow bone. Women in both studies had improved bone strength as measured by bone mineral density.

One concern with romosozumab is that in one study it was found to increase the risk of heart attack and stroke compared with alendronate (Fosamax), another medication commonly used to treat osteoporosis. Therefore, the FDA warns that women who have had a heart attack or stroke within the past year should not take romosozumab until further research can clarify risks.

Mayo Clinic doctors say that romosozumab represents a welcome new treatment option for women at high risk of fracture. This is despite potential cardiovascular side effects and potential high cost and insurance coverage difficulty. For women with a high osteoporosis fracture risk, romosozumab...