The results of a study presented at the Annual European Congress of Rheumatology (EULAR) 2017 press conference showed that, in postmenopausal women with osteoporosis, 12 months treatment with romosozumab was associated with rapid and large reductions in their risk of a vertebral fracture compared to placebo.
In those women receiving romosozumab, all clinical vertebral fractures occurred in the first two months of treatment; overall, the risk of a vertebral fracture was more than five times greater in the group of women given placebo.
“These results support this new class of drug as a highly effective treatment for postmenopausal women with osteoporosis with established bone mineral density (BMD) deficit who are at increased risk of fracture,” said Professor Piet Geusens lead author from Maastricht University, The Netherlands. “The rapid and large reduction in clinical vertebral fracture risk is an important and highly relevant clinical outcome,” he added.
Romosozumab is a monoclonal antibody that binds and inhibits sclerostin (a glycoprotein produced by bone cells). This action has the dual effect of increasing bone formation and decreasing bone resorption, resulting in significant increases in BMD. Previous studies have shown that romosozumab, administered subcutaneously at monthly intervals over a period of 12 months, resulted in gains in both the trabecular and cortical compartments of the spine and hip regions.
The Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) is an international, randomised, double-blind, placebo-controlled, parallel-group trial. FRAME enrolled 7,180 postmenopausal women, 55-85 years old, with evidence of osteoporosis confirmed b