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Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis.
J Clin Endocrinol Metab. 2020 03 01; 105(3)JC

Abstract

CONTEXT

The ACTIVE study demonstrated the antifracture efficacy of abaloparatide in postmenopausal women with osteoporosis. ACTIVExtend demonstrated sustained fracture risk reduction with alendronate in abaloparatide-treated participants from ACTIVE. A direct comparison of the efficacy of abaloparatide and antiresorptive therapies has not been performed.

OBJECTIVE

The objective of this analysis is to compare the antifracture efficacy of abaloparatide in ACTIVE with that of alendronate in ACTIVExtend.

DESIGN

In this post hoc analysis, the rate of new vertebral fractures for women in ACTIVExtend (N = 1139) was calculated based on baseline and endpoint radiographs for placebo or abaloparatide in ACTIVE and alendronate in ACTIVExtend. Vertebral fracture rates between abaloparatide and alendronate were compared in a Poisson regression model. Fracture rates for nonvertebral and clinical fractures were compared based on a Poisson model during 18 months of abaloparatide or placebo treatment in ACTIVE and 18 months of alendronate treatment in ACTIVExtend.

RESULTS

The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction 71%; P = .027). Although the comparisons did not meet statistical significance, after switching from placebo (ACTIVE) to alendronate (ACTIVExtend), the rate of new vertebral fractures decreased from 2.49 to 1.66 fractures per 100 patient-years, and after switching from abaloparatide to alendronate from 0.47 to 0.19 fractures per 100 patient-years. The rates of nonvertebral fractures and clinical fractures were not significantly different.

CONCLUSION

Initial treatment with abaloparatide may result in greater vertebral fracture reduction compared with alendronate in postmenopausal women with osteoporosis.

Authors+Show Affiliations

Endocrinology Unit, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, USA.Radius Health, Inc, Waltham, MA, USA.Radius Health, Inc, Waltham, MA, USA.Radius Health, Inc, Waltham, MA, USA.Joan and Sanford Weill Medical College of Cornell University, Hospital for Special Surgery, New York, NY, USA.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31674644

Citation

Leder, Benjamin Z., et al. "Effect of Abaloparatide Vs Alendronate On Fracture Risk Reduction in Postmenopausal Women With Osteoporosis." The Journal of Clinical Endocrinology and Metabolism, vol. 105, no. 3, 2020.
Leder BZ, Mitlak B, Hu MY, et al. Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020;105(3).
Leder, B. Z., Mitlak, B., Hu, M. Y., Hattersley, G., & Bockman, R. S. (2020). Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. The Journal of Clinical Endocrinology and Metabolism, 105(3). https://doi.org/10.1210/clinem/dgz162
Leder BZ, et al. Effect of Abaloparatide Vs Alendronate On Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2020 03 1;105(3) PubMed PMID: 31674644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Abaloparatide vs Alendronate on Fracture Risk Reduction in Postmenopausal Women With Osteoporosis. AU - Leder,Benjamin Z, AU - Mitlak,Bruce, AU - Hu,Ming-Yi, AU - Hattersley,Gary, AU - Bockman,Richard S, PY - 2019/07/19/received PY - 2019/10/25/accepted PY - 2019/11/2/pubmed PY - 2020/11/11/medline PY - 2019/11/2/entrez KW - abaloparatide KW - alendronate KW - nonvertebral fractures KW - osteoporosis KW - vertebral fractures JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 105 IS - 3 N2 - CONTEXT: The ACTIVE study demonstrated the antifracture efficacy of abaloparatide in postmenopausal women with osteoporosis. ACTIVExtend demonstrated sustained fracture risk reduction with alendronate in abaloparatide-treated participants from ACTIVE. A direct comparison of the efficacy of abaloparatide and antiresorptive therapies has not been performed. OBJECTIVE: The objective of this analysis is to compare the antifracture efficacy of abaloparatide in ACTIVE with that of alendronate in ACTIVExtend. DESIGN: In this post hoc analysis, the rate of new vertebral fractures for women in ACTIVExtend (N = 1139) was calculated based on baseline and endpoint radiographs for placebo or abaloparatide in ACTIVE and alendronate in ACTIVExtend. Vertebral fracture rates between abaloparatide and alendronate were compared in a Poisson regression model. Fracture rates for nonvertebral and clinical fractures were compared based on a Poisson model during 18 months of abaloparatide or placebo treatment in ACTIVE and 18 months of alendronate treatment in ACTIVExtend. RESULTS: The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction 71%; P = .027). Although the comparisons did not meet statistical significance, after switching from placebo (ACTIVE) to alendronate (ACTIVExtend), the rate of new vertebral fractures decreased from 2.49 to 1.66 fractures per 100 patient-years, and after switching from abaloparatide to alendronate from 0.47 to 0.19 fractures per 100 patient-years. The rates of nonvertebral fractures and clinical fractures were not significantly different. CONCLUSION: Initial treatment with abaloparatide may result in greater vertebral fracture reduction compared with alendronate in postmenopausal women with osteoporosis. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/31674644/Effect_of_Abaloparatide_vs_Alendronate_on_Fracture_Risk_Reduction_in_Postmenopausal_Women_With_Osteoporosis_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/clinem/dgz162 DB - PRIME DP - Unbound Medicine ER -