Romosozumab Plus Alendronate Reduces Fracture Risk in Postmenopausal Osteoporosis
Twelve months of romosozumab followed by alendronate resulted in "significantly lower" fracture risk.
HealthDay News — Romosozumab treatment followed by alendronate is linked to reduced risk of fractures vs alendronate alone for postmenopausal women with osteoporosis, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the 2017 American Society for Bone and Mineral Research (ASBMR) annual meeting, held September 8-11 in Denver, Colorado.
Kenneth G. Saag, MD, from the University of Alabama in Birmingham, and colleagues randomized 4093 postmenopausal women with osteoporosis and a fragility fracture to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months, followed by open-label alendronate in both groups.
The researchers found that the risk of new vertebral fracture was 48% lower in the romosozumab-to-alendronate vs the alendronate-to-alendronate group (6.2% vs 11.9%; P <.001), over a period of 24 months. Clinical fractures occurred in 9.7% and 13% of patients in the romosozumab-to-alendronate and the alendronate-to-alendronate groups, respectively (27% lower risk with romosozumab; P <.001). The risk of nonvertebral fractures was 19% percent lower in the romosozumab-to-alendronate vs the alendronate-to-alendronate group (8.7% vs 10.6% percent; P =.04) and the risk of hip fracture was 38% lower (2% vs 3.2%; P =.02).
"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 authors write.
Disclosures: The study was partially funded by Amgen, the manufacturer of romosozumab.
- Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis [published online September 11, 2017]. N Engl J Med. doi:10.1056/NEJMoa1708322
- Rosen CJ. Romosozumab — promising or practice changing? [published online September 11, 2017]. N Engl J Med. doi:10.1056/NEJMe1711298