Treatment with romosozumab for 12 months in postmenopausal women with osteoporosis led to significant reductions in the risk of vertebral fracture vs. placebo. Findings from the study were presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
Romosozumab, a monoclonal antibody, binds and inhibits sclerostin. It works by increasing bone formation and reducing bone resorption, which results in an increase in bone mineral density (BMD).
FRAME (Fracture Study in Postmenopausal Women with Osteoporosis) was an international, randomized, double-blind, placebo-controlled, parallel-group study that evaluated 7,180 postmenopausal women (aged 55–85 years) with osteoporosis as confirmed by low BMD in their spine, hip, and femoral neck but with no severe vertebral fracture. Study patients were randomized to either romosozumab or placebo for 12 months.
Preliminary findings showed romosozumab was associated with a lower risk of new vertebral fractures vs. placebo at 12 months. Romosozumab also demonstrated a “rapid” effect on the risk of vertebral fracture, with only two new fractures reported during Months 6–12.
New data from the FRAME trial addressed clinical vertebral fracture in the women who developed back pain consistent with the diagnosis. X-rays were used to confirm any suspected incidence of clinical vertebral fracture. The data found that 20 of the 119 women were diagnosed with new or worsening vertebral fracture—3 cases in the romosozumab group vs. 17 cases in the placebo group.
The risk of clinical vertebral fracture was calculated to be 83% less in the romosozumab group vs. placebo at 12 months. BMD was indicative of more severe osteoporosis among women with clinical vertebral fracture vs. no fracture but other baseline parameters were similar among all women who reported back pain in both treatment groups.
Lead author, Professor Piet Geusens Maastricht University, The Netherlands, concluded that the study’s findings support this new drug class to be very effective in treating postmenopausal women with osteoporosis with established bone mineral density deficit with increased fracture risk. “The rapid and large reduction in clinical vertebral fracture risk is an important and highly relevant clinical outcome.”
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