Effects of Teriparatide, Denosumab, or Both on Spine Trabecular Microarchitecture in DATA-Switch: a Randomized Controlled Trial.
Effects of Teriparatide, Denosumab, or Both on Spine Trabecular Microarchitecture in DATA-Switch: a Randomized Controlled Trial.
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DOI：
10.1016/j.jocd.2017.05.007
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
Leder BZ
中科院分区：
文献类型：
--
作者：
Tsai JN;Jiang LA;Lee H;Hans D;Leder BZ
在绝经后女性中，特立帕罗和地舒单抗联合治疗2年使骨密度（BMD）增加的幅度大于任何一种单药治疗，从联合治疗或特立帕罗转换为地舒单抗再治疗2年可进一步增加BMD。相反，从地舒单抗转换为特立帕罗导致一过性骨丢失。这些干预措施对脊柱微结构的影响尚不清楚。在DATA和DATA-Switch研究中，94名绝经后骨质疏松症女性随机接受24个月的特立帕鲁肽（20 μ g/天）、地舒单抗（60 mg/6个月）或两者联合治疗。然后，最初分配至24个月特立帕鲁肽组的女性接受24个月地舒单抗治疗，而最初随机分配至24个月地舒单抗组的受试者接受24个月特立帕鲁肽治疗。接受两种药物治疗的受试者额外接受24个月的地舒单抗单药治疗。在0、12、24、30、36和48个月时，对65名具有适合TBS分析的PA脊柱DXA图像的女性使用二维DXA脊柱扫描图像，对治疗组进行盲法测量脊柱骨小梁评分（TBS，骨微结构的灰度纹理评估）。24个月后，特立帕鲁肽组的TBS增加了2.7±4.7%（与基线相比P=0.009），地舒单抗组增加了1.8±5.0%（与基线相比P=0.118），联合用药组增加了4.5±6.7%（与基线相比P=0.017），组间无显著差异。在治疗转换后6个月（第24-30个月），联合治疗至地舒单抗组和特立帕肽至地舒单抗组的TBS继续增加，但地舒单抗至特立帕肽组下降了-1.1 ±4.0%（P<0.05与其他组相比）。48个月后，与第0个月相比，特立帕肽转换地舒单抗组TBS增加5.1±5.8%，地舒单抗转换特立帕肽组TBS增加3.6±4.2%，联合转换地舒单抗组TBS增加6.1±4.7%（所有组与基线相比P<0.001，组间差异P=NS）。从特立帕肽转换为地舒单抗也会增加脊柱TBS。相反，从地舒单抗转换为特立帕肽会短暂降解脊柱小梁微结构，其临床后果需要进一步研究。
In postmenopausal women, 2-years of combined teriparatide and denosumab increases bone mineral density (BMD) more than either drug alone and switching from either combination or teriparatide to denosumab for an additional 2-years further increases BMD. Conversely switching from denosumab to teriparatide results in transient bone loss. The effects of these interventions on spine microarchitecture are unknown. In the DATA and DATA-Switch studies, 94 postmenopausal osteoporotic women were randomized to receive 24-months of teriparatide (20-μg-daily), denosumab (60-mg-every-6-months), or both. Then, women originally assigned to 24-months of teriparatide received 24-months of denosumab whereas subjects originally randomized to 24-months of denosumab received 24-months of teriparatide. Subjects who received both drugs received an additional 24-months of denosumab alone. Spine trabecular bone score (TBS, a gray-level textural assessment of bone microarchitecture) was measured blinded from treatment groups using images from 2-dimensional DXA spine scans at 0, 12, 24, 30, 36, and 48 months in 65 women who had PA spine DXA images suitable for TBS analysis. After 24 months, TBS increased by 2.7±4.7% in the teriparatide group (P=0.009 versus baseline), by 1.8±5.0% in the denosumab group (P=0.118 versus baseline), and by 4.5±6.7% in the combination group (P=0.017 versus baseline), with no significant between-group differences. In the 6-months after treatments were switched (months 24–30), TBS continued to increase in the combination-to-denosumab and teriparatide-to-denosumab groups but decreased by −1.1±4.0% in the denosumab-to-teriparatide group (P<0.05 versus other groups). After 48 months, compared to month 0, TBS increased by 5.1±5.8% in the teriparatide-to-denosumab group, by 3.6±4.2% in the denosumab-to-teriparatide group, and by 6.1±4.7% in the combination-to-denosumab group (P<0.001 versus baseline for all groups, P=NS for between group differences). Switching from teriparatide-to-denosumab also increases spine TBS. Conversely, switching from denosumab-to-teriparatide transiently degraded spine trabecular microarchitecture, the clinical consequences of which require further study.
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影响因子：
4.2
作者：
Leib, E.;Winzenrieth, R.;Hans, D.
通讯作者：
Hans, D.
影响因子：
4.1
作者：
Di Gregorio, S.;Del Rio, L.;Winzenrieth, R.
通讯作者：
Winzenrieth, R.
影响因子：
4
作者：
Kalder, M.;Kyvernitakis, I.;Hadji, P.
通讯作者：
Hadji, P.
影响因子：
2.5
作者：
Krueger, Diane;Fidler, Ellen;Binkley, Neil
通讯作者：
Binkley, Neil
影响因子：
4.1
作者：
Briot, Karine;Paternotte, Simon;Roux, Christian
通讯作者：
Roux, Christian