Abstract：
BACKGROUND: 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.
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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：
背景：为了确定终止特立帕肽（TPTD）和阿仑膦酸钠（ALN）治疗的预测因素，来自随机数据，对涉及绝经后高骨折风险日本女性的对照试验(JOINT-05)进行了重新分析.
方法：参与者接受序贯治疗，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）。背景数据包括合并症，骨折患病率,认知功能,生活质量,日常生活活动,骨代谢参数，并收集营养摄入量。终点是3种类型的停药，原因是：依从性差，不良事件（AE），或任何原因，包括与AE或不良合规性无关的原因。通过单一或多元回归分析评估停药的基线预测因子的赔率（OR）。
结果：TPTD-ALN组共有234例（49.0%）患者和ALN组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重要预测因子.血清钙水平较低的患者血清25-羟基维生素D水平低于血清钙水平较高的患者。在ALN组中，认知功能低下与依从性相关的停药显著相关，较高的体重指数和酒精摄入量是AE相关停药的预测因素。停药的预测因素是药物特异性的。较低的血清钙水平和较差的认知功能是每周停止一次TPTD和ALN的预测因素，分别。
结论：开始TPTD和ALN治疗时，仔细注意血清钙水平较低和认知功能较差的患者，分别,可能需要更好的治疗连续性。
方法：参与者接受序贯治疗，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）。背景数据包括合并症，骨折患病率,认知功能,生活质量,日常生活活动,骨代谢参数，并收集营养摄入量。终点是3种类型的停药，原因是：依从性差，不良事件（AE），或任何原因，包括与AE或不良合规性无关的原因。通过单一或多元回归分析评估停药的基线预测因子的赔率（OR）。
结果：TPTD-ALN组共有234例（49.0%）患者和ALN组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重要预测因子.血清钙水平较低的患者血清25-羟基维生素D水平低于血清钙水平较高的患者。在ALN组中，认知功能低下与依从性相关的停药显著相关，较高的体重指数和酒精摄入量是AE相关停药的预测因素。停药的预测因素是药物特异性的。较低的血清钙水平和较差的认知功能是每周停止一次TPTD和ALN的预测因素，分别。
结论：开始TPTD和ALN治疗时，仔细注意血清钙水平较低和认知功能较差的患者，分别,可能需要更好的治疗连续性。
