绝经后骨质疏松症女性的前臂骨矿物质密度与骨折发生率：来自 ACTIVExtend 阶段 3 试验的结果。
Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial.
机构信息
Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA.
Robin K. Dore, MD, Inc., Tustin, CA, USA.
出版信息
Osteoporos Int. 2021 Jan;32(1):55-61. doi: 10.1007/s00198-020-05555-1. Epub 2020 Sep 15.
UNLABELLED
Abaloparatide increased ultradistal radius bone mineral density (BMD) in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. Over the subsequent 24 months in ACTIVExtend, ultradistal radius BMD gains were maintained with alendronate. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.
INTRODUCTION
Abaloparatide (ABL) increased femoral neck, total hip, and lumbar spine bone mineral density (BMD) in postmenopausal women with osteoporosis and decreased the risk of vertebral and nonvertebral fractures in ACTIVE. Effects on fracture risk and BMD were maintained subsequently with alendronate (ALN) in ACTIVExtend. In a prespecified subanalysis of ACTIVE, ABL also increased BMD at the ultradistal radius. Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.
METHODS
Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233). Wrist fracture rates were estimated for the ACTIVExtend intent-to-treat population (ABL/ALN, n = 558; PBO/ALN, n = 581) by Kaplan-Meier (KM) method.
RESULTS
At cumulative month 25, mean increase from ACTIVE baseline in ultradistal radius BMD was 1.1% (standard error, 0.49%) with ABL/ALN vs - 0.8% (0.43%) with PBO/ALN (P < 0.01). BMD increases with ABL were maintained with ALN through month 43 in ACTIVExtend. BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend. Wrist fractures over 43 months occurred in 15 women with ABL/ALN (KM estimate, 2.8%) and 20 with PBO/ALN (KM estimate, 3.6%) (HR = 0.77, 95% CI 0.39, 1.50; P = not significant).
CONCLUSION
Ultradistal radius BMD gains following treatment with ABL in ACTIVE were maintained over 24 months of ALN treatment in ACTIVExtend. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.
TRIAL REGISTRATION
ClinicalTrials.gov : NCT01657162 submitted July 31, 2012.
目的
在 ACTIVExtend 中，阿巴洛肽（ABL）联合阿仑膦酸钠（ALN）治疗 24 个月后，超远端桡骨骨密度（BMD）增加，而在 ACTIVExtend 中，ALN 治疗期间 1/3 半径 BMD 保持稳定。
方法
测量超远端和 1/3 半径 BMD（ACTIVE 基线至 43 个月）（ABL/ALN，n=213；PBO/ALN，n=233）。腕部骨折发生率采用 Kaplan-Meier（KM）法估算（ABL/ALN，n=558；PBO/ALN，n=581）。
结果
在累积月 25 时，与 PBO/ALN 相比，ABL/ALN 治疗超远端桡骨 BMD 的平均增加率为 1.1%（标准误差，0.49%）（P<0.01）。在 ACTIVExtend 中，ABL 联合 ALN 治疗 25 个月后，BMD 增加得到维持。在 ACTIVE 中，1/3 半径的 BMD 下降（与 ABL 和 PBO 相似），在 ACTIVExtend 中，24 个月的 ALN 治疗后保持稳定。在 43 个月内，ABL/ALN 组有 15 名女性（KM 估计值为 2.8%）和 PBO/ALN 组有 20 名女性（KM 估计值为 3.6%）发生腕部骨折（HR=0.77，95%CI 0.39，1.50；P=无显著性差异）。
结论
在 ACTIVE 中用 ABL 治疗后，超远端桡骨 BMD 增加在 ACTIVExtend 中用 ALN 治疗 24 个月后仍保持增加。相反，在 ACTIVE 中，1/3 半径 BMD 在 ALN 治疗期间保持稳定，而在 ACTIVE 中则下降。
试验注册
ClinicalTrials.gov：NCT01657162 于 2012 年 7 月 31 日提交。
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