Bone mineral density response with denosumab in combination with standard or high-dose teriparatide: the DATA-HD RCT.
Bone mineral density response with denosumab in combination with standard or high-dose teriparatide: the DATA-HD RCT.
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DOI：
10.1210/clinem/dgz163
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发表时间：
2020-03
期刊：
影响因子：
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通讯作者：
S. Ramchand;Natalie L David;B. Leder;J. Tsai
中科院分区：
文献类型：
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作者：
S. Ramchand;Natalie L David;B. Leder;J. Tsai
在DATA-HD研究中，我们报告了联合服用大剂量(HD)Teriparatide和地诺单抗15个月比联合使用Denosumab和标准剂量Teriparatide(SD)更能增加髋部和脊柱的平均面骨密度(ABMD)。目的在目前的分析中，我们比较治疗组之间的个体aBMD应答率。设计一项单地点、开放标签、随机对照试验，绝经后妇女每天服用20-μg(SD)或40-μg(HD)，给药0-9个月，同时给予3-15个月(总疗程15个月)地诺单抗60-mg。比较了SD组和HD组受试者的全髋关节、股骨颈和腰椎骨密度分别增加3%、6%和9%的比例。研究对象绝经后骨质疏松症妇女完成所有研究访问(n=60)。主要观察指标(S)骨密度(双X线骨密度仪)。结果15个月治疗结束时，HD组女性全髋部骨密度增加3%(83%对58%，P=0.037)，股骨颈增加6%(45%对19%，P=0.034)，股骨颈增加3%(86%对63%，P=0.044)。在腰椎，>；3%的有效率相似，而HD组的>；6%和>；9%的有效率更高(分别为100%和79%，P=0.012和93%和59%，P=0.003)。结论与SD方案相比，HD方案治疗的妇女在髋部和脊柱骨密度方面取得了更多有临床意义的、快速的改善。这些结果表明，这种方法可能在治疗绝经后骨质疏松症方面提供独特的好处。
CONTEXT In the DATA-HD study, we reported that 15-months of combined high-dose (HD) teriparatide and denosumab increased mean areal bone mineral density (aBMD) at the hip and spine more than combined denosumab and standard-dose teriparatide (SD). OBJECTIVE In the current analysis, we compare the individual rates of aBMD response between the treatment groups. DESIGN Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0-9, overlapped with denosumab 60-mg, given months 3-15 (15-month total duration). The proportion of participants in the SD and HD groups experiencing total hip, femoral neck, and lumbar spine aBMD gains of >3%, >6%, and >9% were compared. PARTICIPANTS Postmenopausal women with osteoporosis completing all study visits (n = 60). MAIN OUTCOME MEASURE(S) aBMD (dual x-ray absorptiometry). RESULTS At the end of the 15-month treatment period, a higher proportion of women in the HD group had BMD increases >3% (83% vs. 58%, P=0.037) and >6% (45% vs. 19%, P=0.034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P=0.044). At the lumbar spine, >3% response rates were similar whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P=0.012 and 93% vs. 59%, P=0.003, respectively). CONCLUSION Compared with the SD regimen, more women treated with the HD regimen achieved clinically meaningful and rapid gains in hip and spine aBMD. These results suggest that this approach may provide unique benefits in the treatment of postmenopausal osteoporosis.