绝经后骨质疏松症患者每日特立帕肽、每周高剂量特立帕肽与双膦酸盐的随机对照试验：TERABIT 研究。
Randomized controlled trial of daily teriparatide, weekly high-dose teriparatide, or bisphosphonate in patients with postmenopausal osteoporosis: The TERABIT study.
机构信息
Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan.
Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki University Hospital, Japan.
出版信息
Bone. 2022 Jul;160:116416. doi: 10.1016/j.bone.2022.116416. Epub 2022 Apr 6.
PURPOSE
The effects of daily teriparatide (20 μg) (D-PTH), weekly high-dose teriparatide (56.5 μg) (W-PTH), or bisphosphonates (BPs) on areal bone mineral density (aBMD), bone turnover markers (BTMs), volumetric BMD (vBMD), microarchitecture, and estimated strength were investigated in postmenopausal osteoporosis patients.
METHODS
The study participants were 131 women with a history of fragility fractures. They were randomized to receive D-PTH, W-PTH, or BPs (alendronate or risedronate) for 18 months. Dual-energy X-ray absorptiometry (DXA), BTMs, and high-resolution peripheral quantitative CT (HR-pQCT) parameters were evaluated at baseline and after 6 and 18 months of treatment. The primary endpoint was the change (%) in cortical thickness (Ct.Th) after 18 months' treatment compared with baseline.
RESULTS
DXA showed that D-PTH, W-PTH, and BPs increased lumbar spine aBMD (+12.0%, +8.5%, and +6.8%) and total hip aBMD (+3.0%, +2.1%, and +3.0%), but D-PTH and W-PTH decreased 1/3 radius aBMD (-4.1%, -3.0%, -1.4%) after 18 months. On HR-pQCT, D-PTH increased trabecular vBMD (Tb.vBMD) at the distal radius and tibia after 18 months (+6.4%, +3.7%) compared with the BPs group, decreased cortical volumetric tissue mineral density (Ct.vTMD) (-1.8%, -0.9%) compared with the other groups, increased Ct.Th (+1.3%, +3.9%), and increased failure load (FL) (+4.7%, +4.4%). W-PTH increased Tb.vBMD (+5.3%, +1.9%), maintained Ct.vTMD (-0.7%, +0.2%) compared with D-PTH, increased Ct.Th (+0.6%, +3.6%), and increased FL (+4.9%, +4.5%). The BPs increased Tb.vBMD only in the radius (+2.0%, +0.2%), maintained Ct.vTMD (-0.6%, +0.3%), increased Ct.Th (+0.5%, +3.4%), and increased FL (+3.9%, +2.8%).
CONCLUSIONS
D-PTH and W-PTH comparably increased Ct.Th, the primary endpoint. D-PTH had a strong effect on trabecular bone. Although D-PTH decreased Ct.vTMD, it increased Ct.Th and total bone strength. W-PTH had a moderate effect on trabecular bone, maintained Ct.vTMD, and increased Ct.Th and total bone strength to the same extent as D-PTH.
目的
研究每日特立帕肽（20μg）（D-PTH）、每周高剂量特立帕肽（56.5μg）（W-PTH）或双膦酸盐（BPs）对绝经后骨质疏松症患者的骨矿密度（aBMD）、骨转换标志物（BTMs）、体积骨密度（vBMD）、微结构和估计强度的影响。
方法
研究参与者为 131 名有脆性骨折史的女性。她们被随机分配接受 D-PTH、W-PTH 或 BPs（阿仑膦酸钠或利塞膦酸钠）治疗 18 个月。基线时以及治疗 6 个月和 18 个月后，使用双能 X 线吸收法（DXA）、BTMs 和高分辨率外周定量 CT（HR-pQCT）参数进行评估。主要终点是与基线相比，治疗 18 个月后皮质厚度（Ct.Th）的变化（%）。
结果
DXA 显示 D-PTH、W-PTH 和 BPs 增加了腰椎 aBMD（+12.0%、+8.5%和+6.8%）和全髋关节 aBMD（+3.0%、+2.1%和+3.0%），但 D-PTH 和 W-PTH 治疗 18 个月后 1/3 桡骨 aBMD 减少（-4.1%、-3.0%、-1.4%）。在 HR-pQCT 上，与 BPs 组相比，D-PTH 治疗 18 个月后增加了桡骨远端和胫骨的小梁 vBMD（Tb.vBMD）（+6.4%、+3.7%），降低了皮质容积骨密度（Ct.vTMD）（-1.8%、-0.9%），增加了 Ct.Th（+1.3%、+3.9%），并增加了断裂负荷（FL）（+4.7%、+4.4%）。W-PTH 增加了 Tb.vBMD（+5.3%、+1.9%），与 D-PTH 相比，维持了 Ct.vTMD（-0.7%、+0.2%），增加了 Ct.Th（+0.6%、+3.6%），并增加了 FL（+4.9%、+4.5%）。BPs 仅在桡骨中增加了 Tb.vBMD（+2.0%、+0.2%），维持了 Ct.vTMD（-0.6%、+0.3%），增加了 Ct.Th（+0.5%、+3.4%），并增加了 FL（+3.9%、+2.8%）。
结论
D-PTH 和 W-PTH 均可增加主要终点 Ct.Th。D-PTH 对小梁骨有很强的作用。尽管 D-PTH 降低了 Ct.vTMD，但它增加了 Ct.Th 和总骨强度。W-PTH 对小梁骨有中等的作用，维持了 Ct.vTMD，并与 D-PTH 相同程度地增加了 Ct.Th 和总骨强度。
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