Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
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.
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 September 23, 2021.
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ACR Meeting Abstracts - 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/