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

Mattias Lorentzon; Helena Johansson; Nicholas C. Harvey; Enwu Liu; Liesbeth Vandenput; Carolyn J. Crandall; Jane A. Cauley; Meryl S. LeBoff; Eugene V. McCloskey; John A. Kanis

doi:10.1007/s00198-022-06483-y

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

Mattias Lorentzon, Helena Johansson, Nicholas C. Harvey, Enwu Liu, Liesbeth Vandenput, Carolyn J. Crandall, Jane A. Cauley, Meryl S. LeBoff, Eugene V. McCloskey, John A. Kanis

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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.

Original language	English
Pages (from-to)	2297-2305
Number of pages	9
Journal	Osteoporosis International
Volume	33
Issue number	11
Early online date	14 Jul 2022
DOIs	https://doi.org/10.1007/s00198-022-06483-y
Publication status	Published - Nov 2022
Externally published	Yes

Keywords

Epidemiology
Falls
Fracture risk
FRAX
Menopausal hormone therapy
Osteoporosis
Postmenopausal women

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Lorentzon, M., Johansson, H., Harvey, N. C., Liu, E., Vandenput, L., Crandall, C. J., Cauley, J. A., LeBoff, M. S., McCloskey, E. V., & Kanis, J. 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. https://doi.org/10.1007/s00198-022-06483-y

@article{961278e591e34bbea9e41a09efbe9c4c,

title = "Menopausal hormone therapy reduces the risk of fracture regardless of falls risk or baseline FRAX probability—results from the Women{\textquoteright}s Health Initiative hormone therapy trials",

abstract = "Summary: In a combined analysis of 25,389 postmenopausal women aged 50–79 years, enrolled in the two Women{\textquoteright}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{\textquoteright}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, Osteoporosis, Postmenopausal women",

author = "Mattias Lorentzon and Helena Johansson and Harvey, {Nicholas C.} and Enwu Liu and Liesbeth Vandenput and Crandall, {Carolyn J.} and Cauley, {Jane A.} and LeBoff, {Meryl S.} and McCloskey, {Eugene V.} and Kanis, {John A.}",

year = "2022",

month = nov,

doi = "10.1007/s00198-022-06483-y",

language = "English",

volume = "33",

pages = "2297--2305",

journal = "Osteoporosis International",

issn = "0937-941X",

number = "11",

}

Lorentzon, M, Johansson, H, Harvey, NC, Liu, E, Vandenput, L, Crandall, CJ, Cauley, JA, LeBoff, MS, McCloskey, EV & Kanis, JA 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, vol. 33, no. 11, pp. 2297-2305. https://doi.org/10.1007/s00198-022-06483-y

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. et al.

In: Osteoporosis International, Vol. 33, No. 11, 11.2022, p. 2297-2305.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Lorentzon, Mattias

AU - Johansson, Helena

AU - Harvey, Nicholas C.

AU - Liu, Enwu

AU - Vandenput, Liesbeth

AU - Crandall, Carolyn J.

AU - Cauley, Jane A.

AU - LeBoff, Meryl S.

AU - McCloskey, Eugene V.

AU - Kanis, John A.

PY - 2022/11

Y1 - 2022/11

N2 - 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.

AB - 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.

KW - Epidemiology

KW - Falls

KW - Fracture risk

KW - FRAX

KW - Menopausal hormone therapy

KW - Osteoporosis

KW - Postmenopausal women

UR - http://www.scopus.com/inward/record.url?scp=85134298242&partnerID=8YFLogxK

U2 - 10.1007/s00198-022-06483-y

DO - 10.1007/s00198-022-06483-y

M3 - Article

C2 - 35833956

AN - SCOPUS:85134298242

SN - 0937-941X

VL - 33

SP - 2297

EP - 2305

JO - Osteoporosis International

JF - Osteoporosis International

IS - 11

ER -

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

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