Abaloparatide in Postmenopausal Women With Osteoporosis and Type 2 Diabetes: A Post Hoc Analysis of the ACTIVE Study.

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License: CC BY 4.0
Serval ID
serval:BIB_6D79B602D3A3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Abaloparatide in Postmenopausal Women With Osteoporosis and Type 2 Diabetes: A Post Hoc Analysis of the ACTIVE Study.
Journal
JBMR plus
Author(s)
Dhaliwal R., Hans D., Hattersley G., Mitlak B., Fitzpatrick L.A., Wang Y., Schwartz A.V., Miller P.D., Josse R.G.
ISSN
2473-4039 (Electronic)
ISSN-L
2473-4039
Publication state
Published
Issued date
04/2020
Peer-reviewed
Oui
Volume
4
Number
4
Pages
e10346
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
Type 2 diabetes mellitus (T2DM) increases fracture risk despite normal or increased BMD. Abaloparatide reduces fracture risk in patients with postmenopausal osteoporosis (PMO); however, its efficacy in women with T2DM is unknown. This post hoc analysis evaluated the efficacy and safety of abaloparatide in patients with T2DM. The analysis included patients with T2DM from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), a phase 3, double-blind, randomized, placebo- and active-controlled trial. In ACTIVE, participants were randomized 1:1:1 to daily s.c. injections of placebo, abaloparatide (80 μg), or open-label teriparatide (20 μg) for 18 months. A total of 198 women with PMO and T2DM from 21 centers in 10 countries were identified from ACTIVE through review of their medical records. The main outcomes measured included effect of abaloparatide versus placebo on BMD and trabecular bone score (TBS), with secondary outcomes of fracture risk and safety, in patients from ACTIVE with T2DM. Significant (p < 0.001) improvements in BMD at total hip (mean change 3.0% versus -0.4%), femoral neck (2.6% versus -0.2%), and lumbar spine (8.9% versus 1.3%) and TBS at lumbar spine (3.72% versus -0.56%) were observed with abaloparatide versus placebo at 18 months. Fracture events were fewer with abaloparatide treatment in patients with T2DM, and differences were not significant between groups except nonvertebral fractures in the abaloparatide versus placebo groups (p = 0.04). Safety was consistent with the ACTIVE population. In conclusion, in women with PMO and T2DM, abaloparatide treatment resulted in significant improvements in BMD and TBS versus placebo, consistent with the overall ACTIVE population © 2020 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
Keywords
ABALOPARATIDE, ANABOLICS, BONE MINERAL DENSITY, CLINICAL TRIALS, DXA, FRACTURE PREVENTION, OSTEOPOROSIS, TRABECULAR BONE SCORE, TYPE 2 DIABETES MELLITUS
Pubmed
Open Access
Yes
Create date
25/04/2020 22:19
Last modification date
12/01/2022 8:10
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