Department of Medicine, Endocrine Unit, Massachusetts General Hospital, Harvard University, Boston, MA.
Department of Medicine, Endocrine Unit, Austin Hospital, The University of Melbourne, Victoria, Australia.
J Clin Endocrinol Metab. 2020 Mar 1;105(3):890-7. doi: 10.1210/clinem/dgz163.
In the Denosumab and High-Dose Teriparatide Administration (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 (SD) teriparatide.
In the current analysis, we compare the individual rates of aBMD response between the treatment groups.
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 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' 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.
Postmenopausal women with osteoporosis completing all study visits (n = 60).
MAIN OUTCOME MEASURE(S): aBMD (dual x-ray absorptiometry).
At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .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 = .012 and 93% vs. 59%, P = .003, respectively).
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.
在 denosumab 和高剂量 teriparatide 给药（DATA-HD）研究中，我们报道了 15 个月的联合高剂量（HD）teriparatide 和 denosumab 增加了髋部和脊柱的平均面积骨矿物质密度（aBMD），超过了联合 denosumab 和标准剂量（SD）teriparatide。
在当前的分析中，我们比较了治疗组之间的个体 aBMD 反应率。
单站点、开放标签、随机对照试验，绝经后妇女接受每日 20-μg（SD）或 40-μg（HD）teriparatide 治疗，第 0 至 9 个月，重叠 denosumab 60 mg，第 3 至 15 个月（总持续时间 15 个月）。比较 SD 和 HD 组中髋部、股骨颈和腰椎 aBMD 增加>3%、>6%和>9%的参与者比例。
完成所有研究访视的绝经后骨质疏松症妇女（n=60）。
aBMD（双能 X 线吸收法）。
在 15 个月的治疗期结束时，HD 组中 aBMD 增加>3%（83%比 58%，P=0.037）和>6%（45%比 19%，P=0.034）的女性比例更高髋部，以及股骨颈>3%（86%比 63%，P=0.044）。在腰椎，>3%的反应率相似，而 HD 组的>6%和>9%的反应率更高（100%比 79%，P=0.012 和 93%比 59%，P=0.003，分别）。
与 SD 方案相比，更多接受 HD 方案治疗的女性在髋部和脊柱 aBMD 方面取得了有临床意义的快速增长。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具有独特的益处。
