The effect of abaloparatide-SC on fracture risk is independent of baseline FRAX fracture probability : A post hoc analysis of the ACTIVE study
Journal article
McCloskey, Eugene V., Johansson, Helena, Oden, Anders, Harvey, Nicholas C., Jiang, Hai, Modin, Sara, Fitzpatrick, Lorraine and Kanis, John A.. (2017). The effect of abaloparatide-SC on fracture risk is independent of baseline FRAX fracture probability : A post hoc analysis of the ACTIVE study. Journal of Bone and Mineral Research. 32(8), pp. 1625-1631. https://doi.org/10.1002/jbmr.3163
Authors | McCloskey, Eugene V., Johansson, Helena, Oden, Anders, Harvey, Nicholas C., Jiang, Hai, Modin, Sara, Fitzpatrick, Lorraine and Kanis, John A. |
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Abstract | Daily subcutaneous (SC) injections of the investigational drug abaloparatide‐SC (80 mcg) for 18 months significantly decrease the risk of vertebral and nonvertebral fracture compared with placebo in postmenopausal women. We examined the efficacy of abaloparatide‐SC as a function of baseline fracture risk, assessed using the FRAX tool. Baseline clinical risk factors (age, body mass index [BMI], prior fracture, glucocorticoid use, rheumatoid arthritis, and smoking) were entered into country‐specific FRAX models to calculate the 10‐year probability of major osteoporotic fractures, with or without femoral neck bone mineral density (BMD). The interaction between probability of a major osteoporotic fracture and treatment efficacy was examined by a Poisson regression. A total of 821 women randomized to placebo and 824 women to abaloparatide‐SC, mean age 69 years in both groups, were followed for up to 2 years. At baseline, the 10‐year probability of major osteoporotic fractures (with BMD) ranged from 2.3% to 57.5% (mean 13.2%). Treatment with abaloparatide‐SC was associated with a 69% (95% confidence interval [CI] 38–85%) decrease in major osteoporotic fracture (MOF) and a 43% (95% CI 9–64%) decrease in any clinical fracture compared with placebo. For all outcomes, hazard ratios tended to decrease (ie, greater efficacy) with increasing fracture probability. Whereas the interaction approached significance for the outcome of any fracture (p = 0.11), there was no statistically significant interaction for any of the fracture outcomes. Similar results were noted when FRAX probability was computed without BMD. Efficacy of abaloparatide‐SC to decrease the risk of major osteoporotic fracture or any clinical fracture in postmenopausal women with low BMD and/or prior fracture appears independent of baseline fracture probability. |
Keywords | abaloparatide-SC; fracture risk; FRAX; osteoporosis |
Year | 2017 |
Journal | Journal of Bone and Mineral Research |
Journal citation | 32 (8), pp. 1625-1631 |
Publisher | Wiley-Blackwell Publishing, Inc. |
ISSN | 0884-0431 |
Digital Object Identifier (DOI) | https://doi.org/10.1002/jbmr.3163 |
PubMed ID | 28474780 |
Scopus EID | 2-s2.0-85021257024 |
PubMed Central ID | PMC5553106 |
Open access | Published as green open access |
Page range | 1625-1631 |
Funder | Radius Health, Inc. |
Research Group | Mary MacKillop Institute for Health Research |
Author's accepted manuscript | License All rights reserved File Access Level Open |
Publisher's version | License All rights reserved File Access Level Controlled |
Output status | Published |
Publication dates | |
Online | 26 Jun 2017 |
Publication process dates | |
Accepted | 01 May 2017 |
https://acuresearchbank.acu.edu.au/item/86zv2/the-effect-of-abaloparatide-sc-on-fracture-risk-is-independent-of-baseline-frax-fracture-probability-a-post-hoc-analysis-of-the-active-study
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AM_McCloskey_2017_The_effect_of_abaloparatide_SC_on.pdf | |
License: All rights reserved | |
File access level: Open |
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