Effective Dual-acting Osteoporosis Drug

Apr 9, 2020 by Ameer Helles

Photo credit: monojussi on VisualHunt / CC BY-NC-SA

Approved by the FDA in April 2020, romosozumab is the first osteoporosis drug that has a simultaneous effect on bone formation and an inhibitory effect on bone resorption. In a clinical trial published in the New England Journal of Medicine, postmenopausal osteoporosis women who received romosozumab had a 50% reduced risk of spine fracture and a 38% reduced risk of hip fracture relative to those who received standard anti-resorption therapy!

Additionally, increased bone density is indicated in patients with osteoporosis receiving romosozumab in comparison to the second group receiving alendronate – the standard drug.

The recommendations are based on a study of the evidence from two major phases, three trials evaluating the efficacy of romosozumab in vertebral and non-vertebral fracture risk reduction in postmenopausal women. The frame trial revealed no imbalances in major adverse cardiovascular events (MACEs) or cardiovascular severe adverse events with romosozumab.

"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will decrease this risk," Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products, said in the release.
 

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