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Menopausal hormone therapy reduces the risk of fracture regardless of falls risk or baseline FRAX probability — Results from the Women’s Health Initiative hormone therapy trials
Lorentzon, Mattias Johansson, Helena Harvey, Nicholas C. Liu, Enwu Vandenput, Liesbeth Crandall, Carolyn J. Cauley, Jane A. LeBoff, Meryl S. McCloskey, Eugene V. Kanis, John A.
Lorentzon, Mattias
Johansson, Helena
Harvey, Nicholas C.
Liu, Enwu
Vandenput, Liesbeth
Crandall, Carolyn J.
Cauley, Jane A.
LeBoff, Meryl S.
McCloskey, Eugene V.
Kanis, John A.
Abstract
Summary
In a combined analysis of 25,389 postmenopausal women aged 50–79 years, enrolled in the two Women’s Health Initiative hormone therapy trials, menopausal hormone therapy vs. placebo reduced the risk of fracture regardless of baseline FRAX fracture probability and falls history.
Introduction
The aim of this study was to determine if the anti-fracture efficacy of menopausal hormone therapy (MHT) differed by baseline falls history or fracture risk probability as estimated by FRAX, in a combined analysis of the two Women’s Health Initiative (WHI) hormone therapy trials.
Methods
A total of 25,389 postmenopausal women aged 50–79 years were randomized to receive MHT (n = 12,739) or matching placebo (n = 12,650). At baseline, questionnaires were used to collect information on falls history, within the last 12 months, and clinical risk factors. FRAX 10-year probability of major osteoporotic fracture (MOF) was calculated without BMD. Incident clinical fractures were verified using medical records. An extension of Poisson regression was used to investigate the relationship between treatment and fractures in (1) the whole cohort; (2) those with prior falls; and (3) those without prior falls. The effect of baseline FRAX probability on efficacy was investigated in the whole cohort.
Results
Over 4.3 ± 2.1 years (mean ± SD), MHT (vs. placebo) significantly reduced the risk of any clinical fracture (hazard ratio [HR] 0.72 [95% CI, 0.65–0.78]), MOF (HR 0.60 [95% CI, 0.53–0.69]), and hip fracture (0.66 [95% CI, 0.45–0.96]). Treatment was effective in reducing the risk of any clinical fracture, MOF, and hip fracture in women regardless of baseline FRAX MOF probability, with no evidence of an interaction between MHT and FRAX (p > 0.30). Similarly, there was no interaction (p > 0.30) between MHT and prior falls.
Conclusion
In the combined WHI trials, compared to placebo, MHT reduces fracture risk regardless of FRAX probability and falls history in postmenopausal women.
Keywords
epidemiology, falls, fracture risk, FRAX, menopausal hormone therapy, postmenopausal women, osteoporosis
Date
2022
Type
Journal article
Journal
Osteoporosis International
Book
Volume
33
Issue
11
Page Range
2297-2305
Article Number
ACU Department
Mary MacKillop Institute for Health Research
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
CC BY-NC 4.0
File Access
Open