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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

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
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

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.

Epidemiology, FRAX, Falls, Fracture risk, Menopausal hormone therapy, Osteoporosis, Postmenopausal women
0937-941X
2297-2305
Lorentzen, Mattias
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Johansson, Helena
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Harvey, Nicholas
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Liu, Enwu
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Vandenput, Liesbeth
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Crandall, Carolyn J.
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Cauley, Jane A.
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LaBoff, Meryl S.
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McCloskey, E.V.
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Kanis, John A.
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Lorentzen, Mattias
72997ee0-d7ba-42b1-912e-f60414366449
Johansson, Helena
04f12338-4dd1-437b-b9bc-e0884130c215
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Liu, Enwu
08027c15-9e71-44bb-9623-3081f5f6492d
Vandenput, Liesbeth
0910d143-4b58-4579-82b0-3810272f1814
Crandall, Carolyn J.
e768154e-60be-4e70-8398-d080f87d0fff
Cauley, Jane A.
fbc60b0d-09fd-445d-83df-b61521bcf775
LaBoff, Meryl S.
66b7a02d-6a8b-4d20-bf97-f9d6cfe6a9d1
McCloskey, E.V.
38518227-db8f-4a53-88a6-462f469151de
Kanis, John A.
f1621d8d-8afb-4d97-9679-2165d88a344d

Lorentzen, Mattias, Johansson, Helena, Harvey, Nicholas, Liu, Enwu, Vandenput, Liesbeth, Crandall, Carolyn J., Cauley, Jane A., LaBoff, Meryl S., McCloskey, E.V. and Kanis, John A. (2022) 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. Osteoporosis International, 33 (11), 2297-2305. (doi:10.1007/s00198-022-06483-y).

Record type: Article

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.

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Accepted/In Press date: 22 June 2022
e-pub ahead of print date: 14 July 2022
Published date: November 2022
Additional Information: Funding Information: The WHI program is funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services through contracts HHSN268201100046C, HHSN268201100001C, HHSN268201100002C, HHSN268201100003C, HHSN268201100004C, and HHSN271201100004C.” Publisher Copyright: © 2022, The Author(s).
Keywords: Epidemiology, FRAX, Falls, Fracture risk, Menopausal hormone therapy, Osteoporosis, Postmenopausal women

Identifiers

Local EPrints ID: 469519
URI: http://eprints.soton.ac.uk/id/eprint/469519
ISSN: 0937-941X
PURE UUID: c47b80df-3f5f-43d5-b790-20a2edee694f
ORCID for Nicholas Harvey: ORCID iD orcid.org/0000-0002-8194-2512

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Date deposited: 16 Sep 2022 16:45
Last modified: 17 Mar 2024 02:59

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Contributors

Author: Mattias Lorentzen
Author: Helena Johansson
Author: Nicholas Harvey ORCID iD
Author: Enwu Liu
Author: Liesbeth Vandenput
Author: Carolyn J. Crandall
Author: Jane A. Cauley
Author: Meryl S. LaBoff
Author: E.V. McCloskey
Author: John A. Kanis

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