ACTIVExtend: 24 Months of Alendronate after 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis

ACTIVExtend: 24 Months of Alendronate after 18 Months of Abaloparatide or Placebo for... Abstract Purpose In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO). Methods Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN. We evaluated the incidence of vertebral and nonvertebral fractures and changes in BMD over the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only. Results 558 women from ACTIVE’s ABL group and 581 from its PBO group (92% of ABL and PBO completers) were enrolled. Over the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture versus 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P<0.001). Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN versus PBO/ALN (all P<0.05). Gains in BMD achieved during ACTIVE were further increased during ACTIVExtend. For ACTIVExtend only, RRR for vertebral fractures was 87% with ABL/ALN versus PBO/ALN (P=0.001). Adverse events were similar between groups. A supplementary analysis for regulatory authorities found no hip fractures in the ABL/ALN group versus 5 in the PBO/ALN group. Conclusion 18 months of ABL followed by 24 months of ALN reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and increased BMD. Sequential ABL followed by ALN appears to be an effective treatment option for postmenopausal women at risk for osteoporosis-related fractures. Copyright © 2018 Endocrine Society http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Clinical Endocrinology and Metabolism Oxford University Press

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Publisher
Endocrine Society
Copyright
Copyright © 2018 Endocrine Society
ISSN
0021-972X
eISSN
1945-7197
D.O.I.
10.1210/jc.2018-00163
Publisher site
See Article on Publisher Site

Abstract

Abstract Purpose In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO). Methods Women who completed ABL or PBO treatment in ACTIVE were eligible to receive up to 24 months of ALN. We evaluated the incidence of vertebral and nonvertebral fractures and changes in BMD over the entire 43-month period from ACTIVE baseline to the end of ACTIVExtend and for the 24-month extension only. Results 558 women from ACTIVE’s ABL group and 581 from its PBO group (92% of ABL and PBO completers) were enrolled. Over the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture versus 5.6% of women in the PBO/ALN group, an 84% relative risk reduction (RRR, P<0.001). Kaplan-Meier incidence rates for other reported fracture types were significantly lower for ABL/ALN versus PBO/ALN (all P<0.05). Gains in BMD achieved during ACTIVE were further increased during ACTIVExtend. For ACTIVExtend only, RRR for vertebral fractures was 87% with ABL/ALN versus PBO/ALN (P=0.001). Adverse events were similar between groups. A supplementary analysis for regulatory authorities found no hip fractures in the ABL/ALN group versus 5 in the PBO/ALN group. Conclusion 18 months of ABL followed by 24 months of ALN reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and increased BMD. Sequential ABL followed by ALN appears to be an effective treatment option for postmenopausal women at risk for osteoporosis-related fractures. Copyright © 2018 Endocrine Society

Journal

Journal of Clinical Endocrinology and MetabolismOxford University Press

Published: May 24, 2018

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