Anti-Sclerostin Drug Prevents Vertebral Fractures in Post-Menopausal Osteoporosis Save

Romosozumab is being developed as a novel therapy for osteoporosis. It is a monoclonal antibody that binds sclerostin, and has been shown to increase bone formation while decreasing bone resorption.

The NEJM reports a randomized trial wherein 7180 postmenopausal women with osteoporosis and a T score of –2.5 to –3.5 at the total hip or femoral neck were treated with monthly placebo or subcutaneous romosozumab for 12 months. Thereafter, each group received denosumab 60 mg subcutaneously every 6 months for 12 months.

At 12 months, new vertebral fractures were fewer (0.5%) in the romosozumab group, compared with the placebo group (1.8%) (a 73% lower risk with romosozumab, P0.001).

Clinical fractures had occurred in 58 of 3589 patients (1.6%) in the romosozumab group, as compared with 90 of 3591 (2.5%) in the placebo group (a 36% lower risk with romosozumab, P=0.008).

Interestingly, there were no significant differences in nonvertebral fractures - 1.6% in the romosozumab group and 2.1% in the placebo group (P=0.10).

At 24 months, after the transition to denosumab, the rates of vertebral fractures remained significantly lower in the romosozumab group 0.6% compared with the placebo group (2.5%).

One atypical femoral fracture and two cases of osteonecrosis of the jaw were observed in the romosozumab group.

In postmenopausal women with osteoporosis, romosozumab was associated with a lower risk of vertebral fracture but nonvertebral fractures at 12 months.