Bone Mineral Density After Transitioning From Denosumab to Alendronate.
Bone Mineral Density After Transitioning From Denosumab to Alendronate.
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DOI：
10.1210/clinem/dgz095
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发表时间：
2020-03-01
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影响因子：
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通讯作者：
Stad, Robert Kees
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文献类型：
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作者：
Kendler, David;Chines, Arkadi;Stad, Robert Kees
背景：目的：探讨从地舒单抗转换为阿仑膦酸钠后患者的特征和骨密度的变化。设计：随机、开放、2年交叉的地舒单抗依从性偏好满意度（DAPS）研究地点：美国和加拿大的25个研究中心，患者：未经治疗的绝经后妇女，BMD T-评分为-2.0至-4.0。该事后分析评价了随机分配至第1年每6个月皮下注射地舒单抗60 mg，随后在第2年每周一次口服阿仑膦酸钠70 mg的女性。主要结局指标：3%的BMD阈值确定参与者谁失去了，保持，或获得BMD在第2年对alendronate.RESULTS：126名参与者随机地舒单抗，115（91%）过渡到阿仑膦酸钠在第2年。地舒单抗组第1年BMD增加3%-6%，阿仑膦酸钠组第2年BMD增加0%-1%。在过渡到阿仑膦酸钠后，大多数参与者保持或增加BMD; 15.9%，7.6%和21.7%的腰椎，全髋关节和股骨颈BMD分别下降。很少有参与者低于治疗前的基线BMD值;这最常发生在第2年BMD丢失的患者中。在第2年接受阿仑膦酸钠治疗后BMD下降的女性，在第1年接受地舒单抗治疗后BMD的百分比变化也更大。在第2年的BMD变化是相似的，无论基线特征或坚持口服阿仑膦酸钠。结论：阿仑膦酸钠可以有效地维持在大多数患者的地舒单抗1年后累积的BMD增益，无论基线特征。
CONTEXT: There are few studies on patients transitioning from denosumab to bisphosphonates.OBJECTIVE: To investigate patient characteristics and changes in bone mineral density (BMD) after transitioning from denosumab to alendronate.DESIGN: Randomized, open-label, 2-year crossover Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531).SETTING: 25 study centers in the US and Canada.PATIENTS: Treatment-naive postmenopausal women with BMD T-scores from -2.0 to -4.0.INTERVENTIONS: This post hoc analysis evaluated women randomized to subcutaneous denosumab 60 mg every 6 months in year 1 followed by once-weekly oral alendronate 70 mg in year 2.MAIN OUTCOME MEASURE: A 3% BMD threshold identified participants who lost, maintained, or gained BMD in year 2 on alendronate.RESULTS: Of 126 participants randomized to denosumab, 115 (91%) transitioned to alendronate in year 2. BMD increased by 3% to 6% with denosumab in year 1 and by 0% to 1% with alendronate in year 2. After transitioning to alendronate, most participants maintained or increased BMD; 15.9%, 7.6%, and 21.7% lost BMD at the lumbar spine, total hip, and femoral neck, respectively. Few participants fell below their pretreatment baseline BMD value; this occurred most often in those who lost BMD in year 2. Women who lost BMD with alendronate in year 2 also showed a greater percent change in BMD with denosumab in year 1. The BMD change in year 2 was similar regardless of baseline characteristics or adherence to oral alendronate.CONCLUSION: Alendronate can effectively maintain the BMD gains accrued after 1 year of denosumab in most patients, regardless of baseline characteristics.