Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis
Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis
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DOI：
10.1007/s00198-008-0766-0
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发表时间：
2009-06-01
影响因子：
4
通讯作者：
Krege, J. H.
中科院分区：
文献类型：
--
作者：
Lindsay, R.;Miller, P.;Krege, J. H.
骨折保护和安全性随着特立帕肽 [rhPTH(1-34)] 治疗时间的增加而变化的程度是一个临床相关的尚未解答的问题。在患有骨质疏松症的绝经后女性中，与安慰剂相比，特立帕肽治疗持续时间的增加与非椎体脆性骨折和背痛发生率的逐渐降低相关。特立帕肽 [rhPTH(1-34)] 治疗持续时间对患者结局的影响是一个相关的未解答的问题。患有骨质疏松症的绝经后女性被随机分配到每天一次皮下注射安慰剂 (N = 544)，特立帕肽 20 A μg（TPTD20；N = 541），或特立帕肽 40 A μg（TPTD40；N = 552）加钙和维生素 D 补充剂。使用 Cox 偏似然回归将治疗时间作为线性、时间依赖性协变量，分析治疗开始后首次出现非椎体脆性骨折和新发背痛或背痛恶化的时间。与安慰剂相比，TPTD20 每增加一个月，非椎体脆性骨折的相对风险就会降低 7.3% [风险比 = 0.927，95% CI（0.876 至 0.982），p = 0.009]，TPTD40 每增加一个月，增加 7.6% [风险比 = 0.924，95% CI（0.871 至 0.981），p = 0.009]。安慰剂组的临床椎骨骨折似乎随着时间的推移而增加，而特立帕肽治疗组的临床椎骨骨折主要发生在第一个时间间隔。与安慰剂相比，TPTD20 每增加一个月，背痛的相对风险就会降低 8.3% [风险比 = 0.920，95% CI (0.902 - 0.939)，p < 0.001]，TPTD40 每增加一个月，背痛的相对风险就会降低 8.7% [风险比 = 0.917，95% CI (0.898 - 0.939)，p < 0.001]。 0.935），p < 0.001]。这些研究结果表明，随着特立帕肽治疗持续时间的延长，非椎骨骨折的保护作用增强，背痛减轻，副作用的发生减少。
The extent to which fracture protection and safety varies with increasing time on teriparatide [rhPTH(1-34)] therapy is a clinically relevant unanswered question. In postmenopausal women with osteoporosis, increased duration of teriparatide versus placebo treatment was associated with a progressive decrease in the rates of nonvertebral fragility fractures and back pain.The impact of duration of teriparatide [rhPTH(1-34)] therapy on patient outcomes is a relevant unanswered question.Postmenopausal women with osteoporosis were randomized to once-daily subcutaneous injection with placebo (N = 544), teriparatide 20 A mu g (TPTD20; N = 541), or teriparatide 40 A mu g (TPTD40; N = 552) plus calcium and vitamin D supplementation. The time to first nonvertebral fragility fracture and new or worsening back pain following treatment initiation was analyzed using Cox partial likelihood regression treating time on therapy as a linear, time-dependent covariate.Compared with placebo, the relative hazard for nonvertebral fragility fractures decreased by 7.3% for each additional month of TPTD20 [hazard ratio = 0.927, 95% CI (0.876 to 0.982), p = 0.009] and by 7.6% for each additional month of TPTD40 [hazard ratio = 0.924, 95% CI (0.871 to 0.981), p = 0.009]. Clinical vertebral fractures appeared to increase over time in the placebo group and occurred primarily in the first time interval in the teriparatide treatment groups. Compared with placebo, the relative hazard of back pain was decreased by 8.3% for each additional month of TPTD20 [hazard ratio = 0.920, 95% CI (0.902 to 0.939), p < 0.001] and 8.7% for each additional month of TPTD40 [hazard ratio = 0.917, 95% CI (0.898 to 0.935), p < 0.001].These findings suggest increased nonvertebral fracture protection, reduced back pain, and reduced occurrence of side effects with longer duration of teriparatide therapy.