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两年每日使用特立帕肽治疗对有或无先前抗吸收治疗的严重骨质疏松绝经后妇女骨密度的影响。

Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment.

作者信息

Obermayer-Pietsch Barbara M, Marin Fernando, McCloskey Eugene V, Hadji Peyman, Farrerons Jordi, Boonen Steven, Audran Maurice, Barker Clare, Anastasilakis Athanasios D, Fraser William D, Nickelsen Thomas

机构信息

Klinische Abteilung Endokrinologie/Nuklearmedizin, Universitätsklinik für Innere Medizin, Medizinische Universität, Graz, Austria.

出版信息

J Bone Miner Res. 2008 Oct;23(10):1591-600. doi: 10.1359/jbmr.080506.

Abstract

Previous antiresorptive (AR) treatment may influence the response to teriparatide. We examined BMD response and safety in a subgroup of 503 postmenopausal women with osteoporosis who received teriparatide for 24 mo. Patients were divided into three groups based on their prior AR treatment: treatment-naïve (n = 84); pretreated with no evidence of inadequate treatment response (n = 134); and pretreated showing an inadequate response to AR treatment (n = 285), which was predefined based on the occurrence of fractures, persistent low BMD, and/or significant BMD loss while on therapy. Changes in BMD from baseline were analyzed using mixed model repeated measures. Lumbar spine BMD increased significantly from baseline at 6, 12, 18, and 24 mo in all three groups. The mean gain in spine BMD over 24 mo was greater in the treatment-naïve group (0.095 g/cm(2); 13.1%) than in the AR pretreated (0.074 g/cm(2); 10.2%; p < 0.005) and inadequate AR responder (0.071 g/cm(2); 9.8%; p < 0.001) groups. The corresponding increases in total hip BMD were 3.8%, 2.3%, and 2.3%, respectively. Early decreases in hip BMD in the inadequate AR responder group were reversed by 18 mo of treatment. Increases in BMD between 18 and 24 mo were highly significant. Nausea (13.3%) and arthralgia (11.7%) were the most commonly reported adverse events. Asymptomatic hypercalcemia was reported in 5.0% of patients. Teriparatide treatment for 24 mo is associated with a significant increase in BMD in patients with and without previous AR use. Prior AR treatment modestly blunted the BMD response to teriparatide. Safety was consistent with current prescribing label information.

摘要

既往抗骨吸收(AR)治疗可能会影响对特立帕肽的反应。我们在503例接受特立帕肽治疗24个月的绝经后骨质疏松症女性亚组中研究了骨密度(BMD)反应和安全性。根据患者既往的AR治疗情况将其分为三组:未接受过治疗(n = 84);接受过治疗且无治疗反应不足证据(n = 134);接受过治疗但对AR治疗反应不足(n = 285),后者根据治疗期间骨折的发生、持续低骨密度和/或显著的骨密度丢失预先定义。使用混合模型重复测量分析从基线开始的骨密度变化。所有三组患者腰椎骨密度在6、12、18和24个月时均较基线显著增加。未接受过治疗的组24个月内脊柱骨密度的平均增加幅度(0.095 g/cm²;13.1%)大于接受过AR治疗的组(0.074 g/cm²;10.2%;p < 0.005)和AR治疗反应不足的组(0.071 g/cm²;9.8%;p < 0.001)。全髋骨密度相应的增加分别为3.8%、2.3%和2.3%。AR治疗反应不足组髋骨密度早期的下降在治疗18个月后得到逆转。18至24个月期间骨密度的增加非常显著。恶心(13.3%)和关节痛(11.7%)是最常报告的不良事件。5.0%的患者报告有无症状高钙血症。特立帕肽治疗24个月与既往使用过AR治疗和未使用过AR治疗的患者骨密度显著增加相关。既往AR治疗适度减弱了对特立帕肽的骨密度反应。安全性与当前的处方标签信息一致。

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