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骨质疏松症治疗中断的预测因素:日本骨质疏松症干预试验-05(JOINT-05)的亚组分析。

Predictors of discontinuation of osteoporosis treatment: sub-analysis of the Japanese osteoporosis intervention trial-05 (JOINT-05).

作者信息

Takeuchi Yasuhiro, Nakatsuka Yuki, Tanaka Shiro, Kuroda Tatsuhiko, Hagino Hiroshi, Mori Satoshi, Soen Satoshi

机构信息

Toranomon Hospital Endocrine Center, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.

Okinaka Memorial Institute for Medical Research, Minato-ku, Tokyo, Japan.

出版信息

J Bone Miner Metab. 2024 Nov;42(6):675-680. doi: 10.1007/s00774-024-01541-3. Epub 2024 Aug 14.

Abstract

INTRODUCTION

To identify predictors of discontinuing treatment with teriparatide (TPTD) and alendronate (ALN), data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high risk of fracture were re-analyzed.

MATERIALS AND METHODS

Participants received sequential therapy with once-weekly TPTD for 72 weeks followed by ALN for 48 weeks (TPTD-ALN group) or monotherapy with ALN for 120 weeks (ALN group). Background data including comorbidities, fracture prevalence, cognitive function, quality of life, activities of daily living, bone metabolism parameters, and nutrient intake were collected. The endpoints were 3 types of discontinuations by the reason: a poor compliance, adverse events (AEs), or any reason including those unrelated to AEs or poor compliance. Odds ratios (ORs) of baseline predictors of discontinuation were evaluated by single or multiple regression analysis.

RESULTS

A total of 234 (49.0%) patients in the TPTD-ALN group and 167 (34.2%) patients in the ALN group discontinued. In the TPTD-ALN group, a lower serum calcium level was a significant predictor of compliance-related discontinuation. Serum 25-hydroxyvitamin D levels were lower in patients with lower serum calcium levels than with higher serum calcium levels. In the ALN group, poor cognitive function was significantly associated with compliance-related discontinuation, and higher body mass index and alcohol intake were predictors of AE-related discontinuation. Predictors of discontinuation were drug-specific. Lower serum calcium levels and poor cognitive function were predictors of discontinuing once-weekly TPTD and ALN, respectively.

CONCLUSION

When starting TPTD and ALN treatment, careful attention to patients with lower serum calcium levels and poor cognitive function, respectively, may be needed for better treatment continuity.

摘要

引言

为了确定停用特立帕肽(TPTD)和阿仑膦酸盐(ALN)治疗的预测因素,对一项涉及绝经后日本骨折高危女性的随机对照试验(JOINT - 05)的数据进行了重新分析。

材料与方法

参与者接受序贯治疗,即每周一次TPTD治疗72周,随后ALN治疗48周(TPTD - ALN组),或ALN单药治疗120周(ALN组)。收集包括合并症、骨折患病率、认知功能、生活质量、日常生活活动、骨代谢参数和营养摄入等背景数据。终点为按原因分类的3种停药类型:依从性差、不良事件(AE)或任何原因(包括与AE或依从性差无关的原因)。通过单因素或多因素回归分析评估停药基线预测因素的比值比(OR)。

结果

TPTD - ALN组共有234例(49.0%)患者停药,ALN组有167例(34.2%)患者停药。在TPTD - ALN组中,较低的血清钙水平是依从性相关停药的显著预测因素。血清钙水平较低的患者血清25 - 羟维生素D水平低于血清钙水平较高的患者。在ALN组中,认知功能差与依从性相关停药显著相关,较高的体重指数和酒精摄入量是AE相关停药的预测因素。停药的预测因素具有药物特异性。较低的血清钙水平和认知功能差分别是停用每周一次TPTD和ALN的预测因素。

结论

开始TPTD和ALN治疗时,分别对血清钙水平较低和认知功能差的患者予以密切关注,可能有助于更好地维持治疗的连续性。

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