Fracture Risk Reduced by Romosozumab Treatment

Treatment with romosozumab for 1 year followed by alendronate reduced the risk of fracture among postmenopausal women with osteoporosis and a high fracture risk, according to a recent study.

The study included 4093 postmenopausal women with osteoporosis who had a fragility fracture. Women were randomly assigned to receive 210 mg dose of subcutaneous romosozumab (n=2046) monthly or 70 mg dose of oral alendronate (n=2047) weekly for 12 months, followed by open-label alendronate treatment in both groups. The cumulative incidence of new vertebral fracture at 24 months and the time to cumulative incidence of clinical fracture were assessed as the primary endpoints. Incidences of nonvertebral and hip fracture were assessed as the secondary endpoints. In addition, serious cardiovascular events, osteonecrosis of the jaw, and atypical femoral fractures were adjudicated.
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Overall, patients treated with romosozumab experienced a 48% lower risk for new vertebral fractures over a 24-month period compared with those treated with only alendronate (6.2% vs 11.9%, respectively). Clinical fractures occurred in 198 patients (9.7%) in the romosozumab group and in 266 patients (13%) in the alendronate group. This represented a 27% lower risk for fracture among those treated with romosozumab.

Additionally, romosozumab was found to lower the risk of nonvertebral fractures by 19%, with only 178 patients (8.7%) in the romosozumab group experiencing nonvertebral fractures compared with 217 patients (10.6%) in the alendronate group. Romosozumab was associated with a 38% lower risk for hip fracture, with hip fractures observed in only 41 patients (2%) compared with 66 patients (3.2%) treated with alendronate.

Adverse events and serious adverse events were balanced between groups. Within the first year, positively adjudicated serious cardiovascular events were observed among 50 patients (2.5%) treated with romosozumab compared with 38 patients (1.9%) treated with alendronate. Two events of osteonecrosis of the jaw, 1 in each group, and atypical femoral fracture events, 2 in the romosozumab group and 4 in the alendronate group, were observed during the open-label alendronate period.

“In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone,” the researchers concluded.

—Melissa Weiss

Reference:

Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis [published online October 12, 2017]. N Engl J Med. doi:10.1056/NEJMoa1708322.