Category: Clinical Studies and Observations

22 - Effects of Abaloparatide-SC on Fractures and Bone Mineral Density in Subgroups of Postmenopausal Women With Osteoporosis and Varying Baseline Risk Factors

Introduction: Abaloparatide-SC is an investigational, novel, selective activator of the parathyroid hormone type 1 receptor signaling pathway. In the global, phase 3 ACTIVE (Abaloparatide Comparator Trial in Vertebral Endpoints) trial of 2463 postmenopausal women with osteoporosis, abaloparatide-SC significantly reduced the risk of vertebral and nonvertebral fractures compared to placebo, and significantly reduced the risk of major osteoporotic fractures compared to teriparatide. Abaloparatide-SC also significantly increased bone mineral density (BMD) at the total hip, femoral neck, and lumbar spine at 18 months compared to placebo.


Methods:
We evaluated whether the effects of abaloparatide-SC on fracture risk reductions and BMD increases were consistent across multiple baseline risk factor subgroups, predefined categorically for BMD T-score of the lumbar spine, total hip, and femoral neck (≤-2.5 versus >-2.5 and ≤-3.0 versus >-3.0), history of nonvertebral fracture (yes versus no), prevalent vertebral fracture (yes versus no), and age ( < 65 versus 65 to < 75 versus ≥75 years) at baseline.


Results:
Forest plots show that there were no clinically meaningful interactions between any of the baseline risk factors and the treatment effects of abaloparatide-SC on new morphometric vertebral fractures, nonvertebral fractures, or BMD increases.


Conclusions:
The effects of abaloparatide-SC versus placebo appeared consistent across multiple baseline risk factor subgroups. Abaloparatide-SC may provide protection against fractures consistently across a variety of ages and baseline risks, including patients with and without prior fractures.

Lorraine Fitzpatrick

Chief Medical Officer
Radius Health, Inc.
Wayne, Pennsylvania

Gary Hattersley

Senior Vice President, Research and Development
Radius Health, Inc.
Waltham, Massachusetts

Ming-yi Hu

Executive Director, Statistics and Data Management
Radius Health, Inc.
Parsippany, New Jersey

Greg Williams

Chief Development Officer
Radius Health, Inc.
Waltham, Massachusetts

Felicia Cosman

Professor of Medicine at Columbia University College of Physicians and Surgeons
Helen Hayes Hospital Regional Bone Health
West Haverstraw, New York

Felicia Cosman, M.D. Professor of Medicine, Columbia University, NY and osteoporosis specialist/endocrinologist and medical director of the Clinical Research Center at Helen Hayes Hospital. A graduate of Cornell University and Stony Brook University School of Medical School; she received her internal medicine training and completed her endocrinology fellowship at Columbia Presbyterian Medical Center in NY. Dr. Cosman has studied the causes of osteoporosis and how estrogen, SERMS, and vitamin D work as treatments for osteoporosis. Her major research focus is teriparatide in the treatment of osteoporosis. She has received research grants from the NIH, the DOD, the National Multiple Sclerosis Society, and pharmaceutical companies. Dr. Cosman has served as clinical director or senior clinical director of the National Osteoporosis Foundation since 1996. Dr. Cosman has been featured in hundreds of media articles and broadcasts, including newspaper, magazine, radio, video and television. She has won multiple awards including the Generations Award from the NOF and the top abstract award from the ASBMR.