ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 338

Abaloparatide-SC Significantly Reduces Vertebral and Nonvertebral Fractures and Increases Bone Mineral Density (BMD) Regardless of Age, BMD T-Score, or Prior Fracture at Baseline

F Cosman1, Gary Hattersley2, PD Miller3, Ming-Yu Hu4, Luis Augusto Tavares Russo5, Bente Riis6, Greg Williams7 and Lorraine Fitzpatrick8, 1Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY, 2Research, Radius Health, Inc., Waltham, MA, 3Colorado Center for Bone Research, Lakewood, CO, 4Biometrics, Radius Health, Inc., Waltham, MA, 5CCBR Brasil, Rua Mena Barreto, 33 Botofogo, 22271, Rio de Janeiro, Brazil, 6Nordic Biosciences A/S, 2730 Herlev, Denmark, 7Clinical Development, Radius Health, Inc., Waltham, MA, 8Chief Medical Officer, Radius Health, Inc., Waltham, MA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Sunday, November 13, 2016

Title: Osteoporosis and Metabolic Bone Disease – Clinical Aspects and Pathogenesis - Poster

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:  Abaloparatide is a novel 34 amino acid peptide created to be a potent and selective activator of the PTH 1 receptor signaling pathway and is under investigation for use in the treatment of postmenopausal women with osteoporosis.

Methods: 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. 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 by 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:  Abaloparatide-SC 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-SC reduced morphometric vertebral fractures 86% (p<0.0001), nonvertebral fractures 43% (p=0.049) and major osteoporotic fractures 70% (p=0.0004) compared to placebo and reduced major osteoporotic fractures compared to teriparatide by 55% (p=0.031). 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. In addition, there were no meaningful interactions among any of the baseline risk factors and magnitude of BMD accrual by abaloparatide-SC.

Conclusion:   These data suggest that abaloparatide-SC 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, and will likely be useful for a broad group of postmenopausal women with osteoporosis.

Disclosure: F. Cosman, Radius Health, Inc., 5,Amgen, 5,Amgen, 2,Merck Human Health, 9,Tarsa, 9,Sermonix, 9; G. Hattersley, Radius Health, Inc., 1,Radius Health, Inc., 3; P. Miller, Radius Health, Inc, 5,Radius Health, Inc, 9,AgNovos, 9,Amgen, 9,Eli Lilly and Company, 9,Merck Human Health, 9,Roche Pharmaceuticals, 9,Alexion Pharmaceuticals, Inc., 2,Amgen, 2,Boehringer Ingelheim, 2,Immunodiagnostics, 2,Eli Lilly and Company, 2,Merck Serrano, 2,NBHA, 2,Novartis Pharmaceutical Corporation, 2,Novo Nordisk, 2,Roche Diagnostics, 2,Takeda, 2; M. Y. Hu, Radius Health, Inc., 1,Radius Health, Inc., 3; L. A. T. Russo, None; B. Riis, Nordic Biosciences, 1,Radius Health, Inc, 1; G. Williams, Radius Health, Inc., 1,Radius Health, Inc., 3; L. Fitzpatrick, Radius Health, Inc., 1,Radius Health, Inc., 3.

To cite this abstract in AMA style:

Cosman F, Hattersley G, Miller P, Hu MY, Russo LAT, Riis B, Williams G, Fitzpatrick L. Abaloparatide-SC Significantly Reduces Vertebral and Nonvertebral Fractures and Increases Bone Mineral Density (BMD) Regardless of Age, BMD T-Score, or Prior Fracture at Baseline [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/abaloparatide-sc-significantly-reduces-vertebral-and-nonvertebral-fractures-and-increases-bone-mineral-density-bmd-regardless-of-age-bmd-t-score-or-prior-fracture-at-baseline/. Accessed .

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