The effects of teriparatide on the incidence of back pain in postmenopausal women with osteoporosis
The effects of teriparatide on the incidence of back pain in postmenopausal women with osteoporosis
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DOI：
10.1185/030079905x49671
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发表时间：
2005-07-01
影响因子：
2.3
通讯作者：
Krege, JH
中科院分区：
文献类型：
--
作者：
Genant, HK;Halse, J;Krege, JH
目的：背痛是痛苦，残疾和成本的主要原因。发生背痛的风险进行了评估后，治疗特立哌酮[RH（PTH 1-34）]的研究设计和方法：对全球背痛结果的二次分析，进行了一项多中心骨折预防试验，其中患有普遍椎骨骨折的绝经后妇女服用teriparlavine 20 μ g（n = 541）或安慰剂（n = 544）中位数为19个月。在不良事件监测期间收集治疗后出现的背痛数据，并在基线和研究终点获得脊柱X线片。主要结果测量：根据新发或恶化背痛的严重程度分层的背痛风险，以及与新发椎骨骨折的数量和严重程度相关的背痛风险。随机分配到teriparlavine 20 μ g组的妇女发生中度或重度背痛的相对风险降低了31%（16.5% vs. 11.5%，P = 0.016），严重背痛风险降低57%（5.2% vs. 2.2%，P = 0.011）。与安慰剂相比，特立帕肽治疗患者发生背痛的相对风险降低，与以下结果相关：一个或多个新的脊椎骨折83%（6.5% vs. 1.1%，P < 0.001），两个或更多新椎体骨折减少91%（2.5%vs.0.20%，P = 0.004），以及一个或多个新发中度或重度椎体骨折100%（5.1%vs.0.0%，P < 0.001）。接受特立帕肽治疗的女性发生中度或重度背痛、重度背痛和与椎骨骨折相关的背痛的风险降低。背部疼痛减轻的机制可能包括新椎骨骨折的严重程度和数量的减少。
Objectives: Back pain is a major cause of suffering, disability, and cost. The risk of developing back pain was assessed following treatment with teriparatide [rh(PTH 1-34)] in postmenopausal women with osteoporosis.Research design and methods: A secondary analysis of back pain findings from the global, multi-site Fracture Prevention Trial was conducted where postmenopausal women with prevalent vertebral fractures were administered teriparatide 20 mu g (n = 541) or placebo (n = 544) for a median of 19 months. Treatment-emergent back pain data were collected during adverse event monitoring, and spine radiographs were obtained at baseline and study endpoint.Main outcome measures: The risk of back pain stratified by severity of new or worsening back pain and the risk of back pain associated with both number and severity of new vertebral fractures.Results: Women randomized to teriparatide 20 mu g had a 31% reduced relative risk of moderate or severe back pain (16.5% vs. 11.5%, P = 0.016) and a 57% reduced risk of severe back pain (5.2% vs. 2.2%, P = 0.011). Compared with placebo, teriparatide-treated patients experienced reduced relative risk of developing back pain associated with findings of: one or more new vertebral fractures by 83% (6.5% vs. 1.1%, P < 0.001), two or more new vertebral fractures by 91% (2.5% vs. 0.20%, P = 0.004), and one or more new moderate or severe vertebral fractures by 100% (5.1% vs. 0.0%, P < 0.001).Conclusions. Teriparatide-treated women had reduced risk for moderate or severe back pain, severe back pain, and back pain associated with vertebral fractures. The mechanism of the back pain reduction likely includes the reduction both in severity and number of new vertebral fractures.