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Romosozumab Followed by Alendronate Lowered Risk for Fracture in Women With Osteoporosis
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There was a significantly lower risk for fracture seen among postmenopausal women with osteoporosis who received romosozumab followed by alendronate compared with women who received alendronate alone, according to recently published results.
In a press release from the University of Alabama, Kenneth G. Saag, MD, professor in the division of clinical immunology and rheumatology, said, “Our findings indicate that treatment with romosozumab [Evenity, Amgen/UCB Pharma] for 12 months before alendronate was superior to alendronate alone with respect to the risks of a new vertebral, clinical, nonvertebral and hip fracture. It is worth noting that romosozumab outperformed an effective drug. Alendronate has consistently been shown to reduce vertebral, nonvertebral and hip fractures by up to 50% among patients with osteoporosis.”
Saag and colleagues enrolled 4,093 postmenopausal women with osteoporosis and fragility fracture and randomized them to either receive monthly subcutaneous romosozumab 210 mg or weekly oral alendronate 70 mg in a blinded study for 12 months. After the 12-month period, all women received open-label alendronate. The cumulative, new vertebral fracture incidence at 12 months and cumulative clinical fracture incidence during primary analysis were primary endpoints. Other endpoints were the nonvertebral fracture incidences and hip fracture incidence during the primary analysis.
Results showed a 48% lower risk of sustaining a new vertebral fracture with treatment of romosozumab to alendronate compared with alendronate treatment alone. Investigators noted clinical fractures in 198 patients out of 2,046 patients who received romosozumab first and then alendronate compared with 266 patients out of 2,047 patients who received alendronate alone. Patients who received romosozumab first then alendronate had a 19% lower risk of nonvertebral fractures, with a 38% lower risk of hip fractures.
According to researchers, both groups had similar adverse events and serious adverse events. Within the first 12 months, investigators found serious cardiovascular adverse events occurred more frequently in patients who received romosozumab. – by Monica Jaramillo
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Disclosure: The study was funded by Amgen. Saag reports he receives grants and personal fees from Amgen, grants and personal fees from Merck and personal fees from Radius, outside the submitted work. Please see the full study for a list of all other author’s relevant financial disclosures.
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Saag KG, et al. N Engl J Med. 2017;doi: 10.1056/NEJMoa1708322.
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