New Drug May Increase BMD, Reduce Fracture Risk

A multicenter, international phase 3 ACTIVE trial on the investigational drug abaloparatide-SC indicates that it may help increase bone mineral density (BMD) in postmenopausal women with osteoporosis and reduce their risk of vertebral and nonvertebral fractures. The study was funded by Radius Health, Inc. in Waltham, Massachusetts.

The lead study author, Felicia Cosman, M.D., is an osteoporosis specialist and medical director of the Clinical Research Center at Helen Hayes Hospital, senior clinical director of the National Osteoporosis Foundation and professor of Medicine at Columbia University. She is also a consultant to Radius Health, Inc. In the April 3, 2016 news release, Dr. Cosman noted, “Abaloparatide-SC increased bone mineral density in both the spine and hip and reduced the risk of vertebral and nonvertebral fractures consistently in postmenopausal women with osteoporosis regardless of their baseline patient characteristics, including age, bone mineral density, and whether or not they had prior fractures.”

As indicated in the news release, the randomized, double-blind, study found that “at 18 months, abaloparatide-SC significantly increased bone mineral density from baseline at the lumbar spine by 9.2%, the total hip by 3.4% and the femoral neck by 2.9%, compared with placebo. Abaloparatide-SC also reduced new vertebral fractures by 86%, nonvertebral fractures by 43%, clinical fractures by 43%, and major osteoporotic fractures by 70% compared with placebo after 18 months of treatment. The drug also reduced major osteoporotic fractures by 55% compared with teriparatide and increased bone density to a greater extent in the hip region compared with teriparatide.”

Dr. Cosman told OTW, “Abaloparatide is different than most medications currently marketed because it’s an anabolic (bone forming) drug. It has a unique ability to interact with the parathyroid hormone receptor 1 to optimize the anabolic profile so that it simulates bone formation, but doesn’t stimulate bone degradation as much as teriparatide or other parathyroid hormone-related peptides. So it looks like abaloparatide retains an optimal ability to build bone.

This is another potential medication for orthopedic surgeons to consider using in patients who have had osteoporosis-related fractures. This includes any fractures that occurs in adults in absence of major trauma that excludes only fingers, toes, face, and skull. So banging into furniture, falls, etc. should be thought of as osteoporosis-related fractures. One of the best medications to use in these patients is an anabolic therapy such as abaloparatide if it’s approved.”