The University of Southampton
University of Southampton Institutional Repository

Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis

Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis
Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis
Objective:Advanced age is an important risk factor for fracture. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial showed that subcutaneous abaloparatide increased bone mineral density (BMD) and reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. This study describes the effects of abaloparatide in the subgroup of women aged 80 or more years in ACTIVE. Methods:Post hoc analyses of BMD and fracture incidence in this subgroup of women who received abaloparatide or placebo in the 18-month, phase 3, double-blind, randomized controlled ACTIVE trial. Results:The mean ages of the women ≥80 years were 81.9 and 81.7 years in the placebo (n = 43) and abaloparatide (n = 51) groups, respectively. The increases in BMD from baseline to 18 months with abaloparatide treatment were 3.9% at the total hip (P < 0.001), 3.6% at the femoral neck (P < 0.01), and 12.1% at the lumbar spine (P < 0.001), and were similar to those observed in the overall population. Abaloparatide therapy was associated with numerical, but not statistically significant, reductions in the risk of vertebral and nonvertebral fractures in this subpopulation, compared with placebo. The proportion of participants reporting adverse events was similar between treatment groups and between the older subgroup and the overall population. Conclusion:Abaloparatide was effective in increasing BMD in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population.
1072-3714
McClung, Michael R.
906c38b0-c914-4ff3-a31e-74bd6d895c54
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Fitzpatrick, Lorraine A.
a91178be-96df-4054-97ae-b595f58281cd
Miller, Paul D.
f62a34a2-4bd2-413f-bd3b-a9357e2ea13e
Hattersley, Gary
43a2ec0d-9239-455a-81dd-5873c2018787
Wang, Yamei
adc6c787-e577-46bf-bda7-740d56e7d554
Cosman, Felicia
5247c9a0-d4f0-407b-b678-d290f0885562
McClung, Michael R.
906c38b0-c914-4ff3-a31e-74bd6d895c54
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Fitzpatrick, Lorraine A.
a91178be-96df-4054-97ae-b595f58281cd
Miller, Paul D.
f62a34a2-4bd2-413f-bd3b-a9357e2ea13e
Hattersley, Gary
43a2ec0d-9239-455a-81dd-5873c2018787
Wang, Yamei
adc6c787-e577-46bf-bda7-740d56e7d554
Cosman, Felicia
5247c9a0-d4f0-407b-b678-d290f0885562

McClung, Michael R., Harvey, Nicholas, Fitzpatrick, Lorraine A., Miller, Paul D., Hattersley, Gary, Wang, Yamei and Cosman, Felicia (2018) Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis. Menopause.

Record type: Article

Abstract

Objective:Advanced age is an important risk factor for fracture. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial showed that subcutaneous abaloparatide increased bone mineral density (BMD) and reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. This study describes the effects of abaloparatide in the subgroup of women aged 80 or more years in ACTIVE. Methods:Post hoc analyses of BMD and fracture incidence in this subgroup of women who received abaloparatide or placebo in the 18-month, phase 3, double-blind, randomized controlled ACTIVE trial. Results:The mean ages of the women ≥80 years were 81.9 and 81.7 years in the placebo (n = 43) and abaloparatide (n = 51) groups, respectively. The increases in BMD from baseline to 18 months with abaloparatide treatment were 3.9% at the total hip (P < 0.001), 3.6% at the femoral neck (P < 0.01), and 12.1% at the lumbar spine (P < 0.001), and were similar to those observed in the overall population. Abaloparatide therapy was associated with numerical, but not statistically significant, reductions in the risk of vertebral and nonvertebral fractures in this subpopulation, compared with placebo. The proportion of participants reporting adverse events was similar between treatment groups and between the older subgroup and the overall population. Conclusion:Abaloparatide was effective in increasing BMD in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population.

Text
ACTIVE Elderly Submitted - Accepted Manuscript
Download (232kB)

More information

Accepted/In Press date: 16 January 2018
e-pub ahead of print date: 16 February 2018

Identifiers

Local EPrints ID: 418524
URI: https://eprints.soton.ac.uk/id/eprint/418524
ISSN: 1072-3714
PURE UUID: 6aec422e-08ed-45dc-a41e-5e89f08685f3
ORCID for Nicholas Harvey: ORCID iD orcid.org/0000-0002-8194-2512

Catalogue record

Date deposited: 09 Mar 2018 17:31
Last modified: 03 Dec 2019 05:32

Export record

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×