Birmingham, AL—An alternative treatment for osteoporosis better protects older women against fractures than the current standard treatment, according to a new study.
The report in the New England Journal of Medicine notes that romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone in postmenopausal women with osteoporosis who were at high risk of fracture.
The international, industry-funded study, which was led by University of Alabama Birmingham researchers, is the first to compare the effect of two osteoporosis medicines on fractures.
“With the new treatment, we could offer significantly better protection against fractures and could thereby help many patients with severe osteoporosis,” explained co-author Mattias Lorentzon, MD, PhD, professor of geriatrics at the Institute of Medicine, Sahlgrenska Academy, and senior physician at Sahlgrenska University Hospital in Sweden.
The study enrolled 4,093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups.
Researchers were looking for primary end points that included cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture— nonvertebral and symptomatic vertebral fracture—at the time of the primary analysis after clinical fractures had been confirmed in 330 or more patients.
Secondary end points included the incidences of nonvertebral and hip fracture at the time of the primary analysis.
Results indicate that, over 2 years, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group than in the alendronate-to-alendronate group. Clinical fractures occurred in 9.7% of the romosozumab-to-alendronate group; those outcomes occurred in 13% of the alendronate-to-alendronate group, researchers noted, which represented a 27% lower risk with romosozumab.
At the same time, the risk of nonvertebral fractures was found to be reduced by 19% and the risk of hip fracture lowered by 38% in the romosozumab-to-alendronate group versus the alendronate-to-alendronate group.
Serious cardiovascular adverse events were observed more often with romosozumab than with alendronate, however, 2.5% versus 1.9%. Earlier research involving larger studies did not show that effect, the researchers point out.
Background information in the articles notes that alendronate increases bone density by slowing the breakdown of bone and, decreasing the risk of fractures by 20% to 50%. Romosozumab is an antibody that blocks the substance sclerostin, which slows the new formation of bone, thereby leading to rapid new bone formation.
“With romosozumab in the treatment arsenal, we could prevent many fractures among the high-risk patients,” Lorentzon concluded.
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