OR01-2 Abaloparatide Significantly Reduces Vertebral and Nonvertebral Fractures and Increases BMD Regardless of Baseline Risk

Program: Abstracts - Orals, Poster Previews, and Posters
Session: OR01-Osteoporosis: What You Had, What You Lost, and What You Gain
Friday, April 1, 2016: 11:45 AM-1:15 PM
Presentation Start Time: 12:00 PM
Room 157 (BCEC)
Felicia Cosman*1, Gary Hattersley2, Paul D Miller3, Ming-yi Hu4, Luis Augusto Russo5, Bente Juel Riis6, Gregory C Williams4 and Lorraine A Fitzpatrick7
1Helen Hayes Hospital, West Haverstraw, NY, 2Radius Health, Inc, Waltham, MA, 3Colorado Center for Bone Research, Lakewood, CO, 4Radius Health Inc, Waltham, MA, 5CCBR Rio De Janeiro, Rio de Janiero, Brazil, 6Nordic Biosciences, Copenhagen, Denmark, 7Radius Health, Inc, Radnor, PA
The investigational drug abaloparatide is an osteoanabolic analogue of PTHrP (1-34) that is being studied for potential use in the treatment of postmenopausal osteoporosis. ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) was a trial of 2463 postmenopausal women with osteoporosis (aged 49-86 years; mean=69 years old) who were randomized to double-blinded abaloparatide-SC 80 µg or placebo, or open-label teriparatide 20 µg SC for 18 months. At 18 months, the data show that abaloparatide increased BMD from baseline at the lumbar spine 9.2%, total hip 3.4% and femoral neck 2.9% (all p<0.0001 vs placebo).  Abaloparatide reduced morphometric vertebral fractures 86% (p<0.0001), nonvertebral fractures 43% (p=0.0489) and major osteoporotic fractures 70% (p=0.0004) compared to placebo and reduced major osteoporotic fractures compared to teriparatide by 55% (p=0.0309).  Prespecified subgroup analyses were performed to evaluate if fracture risk reduction was consistent across different levels of baseline risk.  Risk factor subgroups were defined categorically for BMD T-score of the lumbar spine, total hip and femoral neck (≤-2.5 vs >-2.5 and ≤-3.0 vs >-3.0), fracture history (yes vs no), prevalent vertebral fracture (yes vs no) and age (<65 vs 65 to <75 vs ≥75 years old) at baseline.  Results of forest plots show consistent fracture reduction in the abaloparatide arm for new morphometric vertebral or nonvertebral fractures without any interactions caused by baseline risk factors. Furthermore, there were no interactions between any of the baseline risk factors and magnitude of BMD accrual by abaloparatide.  In conclusion, these data suggest that abaloparatide may have potential to provide protection against fractures consistently across a wide variety of ages and baseline risks, including those with and without prior fractures, as well as utility for a broad group of patients with osteoporosis.

Disclosure: FC: Consultant, Amgen, Consultant, Eli Lilly & Company, Consultant, Merck & Co., Consultant, Radius Health, Inc. GH: Chief Scientific Officer, Radius Health, Inc. MYH: Coinvestigator, Radius Health, Inc. LAR: Clinical Researcher, Center for Clinical and Basic Research. BJR: Consultant, Nordic Biosciences. GCW: Chief Operating Officer, Radius Health, Inc. LAF: Chief Medical Officer, Radius Health, Inc. Nothing to Disclose: PDM

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting/pr-resources-for-endo

Sources of Research Support: Radius Health, Inc.