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

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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
Osteoporosis International ( IF 4.2 ) Pub Date : 2022-07-14 , DOI: 10.1007/s00198-022-06483-y
Mattias Lorentzon _{1,

2,

3} , Helena Johansson _{3,

4} , Nicholas C Harvey _{5,

6} , Enwu Liu ₃ , Liesbeth Vandenput _{3,

7} , Carolyn J Crandall ₈ , Jane A Cauley ₉ , Meryl S LeBoff _{10,

11} , Eugene V McCloskey _{12,

13} , John A Kanis _{3,

4}

Affiliation

Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Geriatric Medicine, Sahlgrenska University Hospital Mölndal, 43180, Mölndal, Sweden.
Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.
Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, USA.
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Boston, MA, 02115, USA.
Harvard Medical School, Boston, MA, 02115, USA.
Mellanby Centre for Bone Research, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
Centre for Integrated Research in Musculoskeletal Ageing (CIMA), Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK.

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.

中文翻译：

无论跌倒风险或基线 FRAX 概率如何，更年期激素治疗均可降低骨折风险——女性健康倡议激素治疗试验的结果

概括

对参加两项妇女健康倡议激素治疗试验的 25,389 名 50-79 岁绝经后女性进行的综合分析显示，无论基线 FRAX 骨折概率和跌倒史如何，绝经激素治疗与安慰剂相比均可降低骨折风险。

介绍

本研究的目的是通过对两种妇女健康倡议 (WHI) 激素疗法的综合分析，确定更年期激素疗法 (MHT) 的抗骨折功效是否因基线跌倒史或 FRAX 估计的骨折风险概率而有所不同。试验。

方法

共有 25,389 名 50-79 岁绝经后女性被随机分配接受 MHT（ n = 12,739）或匹配安慰剂（ n = 12,650）。在基线时，使用问卷收集过去 12 个月内跌倒史和临床危险因素的信息。 FRAX 计算主要骨质疏松性骨折 (MOF) 的 10 年概率，无需 BMD。使用医疗记录验证临床骨折事件。使用泊松回归的扩展来研究（1）整个队列中治疗与骨折之间的关系； (2)有跌倒史的； (3) 没有跌倒史的人。在整个队列中研究了基线 FRAX 概率对疗效的影响。

结果

在 4.3 ± 2.1 年（平均值 ± 标准差）内，MHT（与安慰剂相比）显着降低了任何临床骨折的风险（风险比 [HR] 0.72 [95% CI，0.65–0.78]）、MOF（HR 0.60 [95%] CI，0.53–0.69]）和髋部骨折（0.66 [95% CI，0.45–0.96]）。无论基线 FRAX MOF 概率如何，治疗都能有效降低女性任何临床骨折、MOF 和髋部骨折的风险，没有证据表明 MHT 和 FRAX 之间存在相互作用 ( p > 0.30)。同样，MHT 和之前跌倒之间没有交互作用 ( p > 0.30)。