Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis
Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis
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DOI：
10.1001/archinte.164.18.2024
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发表时间：
2004-10-11
影响因子：
--
通讯作者：
Mitlak, BH
中科院分区：
文献类型：
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作者：
Lindsay, R;Scheele, WH;Mitlak, BH
背景：特立帕帝(重组人甲状旁腺激素[1=34])可降低绝经后骨质疏松症妇女的骨折风险。我们评估了停药后新的椎体骨折的安全性和发生率。方法：这项研究是对骨折预防试验(FPT)的随访，该试验是一项对绝经后骨质疏松症妇女进行的随机、安慰剂对照研究，每天服用一次(20或40杯)，平均为期18个月。超过90%的女性在FPT结束后继续进行随访研究(n=1262)。患者和研究人员没有对最初的治疗组分配盲目。妇女根据标准的临床实践进行治疗，包括选择性使用骨质疏松症药物。结果：在随访研究中，与安慰剂相比，与安慰剂相比，使用20和40微克的特瑞帕帝分别降低了41%(P=.004)和45%(P=.001)的骨折风险。从FPT基线到18个月的随访期，两种剂量的绝对降幅均为13%。47%的女性在随访期间使用了骨质疏松症药物，其中以前的安慰剂组使用的更多(P=0.04)；然而，以前的Terparatide治疗对骨折的持续保护作用是明显的。专案后分析还表明，特瑞帕雷治疗显著降低了在FPT期间发生骨折的女性继发骨折风险的增加(P=0.05)。结论：在停止治疗后，特雷帕雷治疗可降低脊椎骨折风险至少18个月。
Background: Teriparatide (recombinant human parathyroid hormone [1=34]) reduces fracture risk in postmenopausal women with osteoporosis. We assessed the safety and incidence of new vertebral fractures after withdrawal of teriparatide.Methods: This study is a follow-up to the Fracture Prevention Trial (FPT), a randomized, placebo-controlled study of postmenopausal women with osteoporosis treated with teriparatide (20 or 40 mug) once daily for a mean of 18 months. More than 90% of the women remaining at the end of the FPT continued into the follow-up study (n=1262). Patients and investigators were unblinded to original treatment group assignment. Women were treated according to standard clinical practice, including elective use of osteoporosis drugs. New vertebral fractures were determined by semiquantitative scoring of lateral thoracic lumbar spine radiographs 18 months after the end of the FPT.Results: During the follow-up study, the reduction in fracture risk associated with previous treatment with teriparatide, 20 and 40 mug, was 41% (P=.004) and 45% (P=.001), respectively, vs placebo. The absolute reduction from the FPT baseline to the 18-month follow-up visit was 13% for both doses. Osteoporosis drugs were used by 47% of women during follow-up, with greater use in the former placebo group (P=.04); nevertheless, persistent fracture protection of previous teriparatide therapy was evident. Post hoc analysis also suggests that teriparatide treatment substantially reduced the increased risk of subsequent fracture in women who sustained a fracture during the FPT (P=.05).Conclusion: Vertebral fracture risk reduction by teriparatide administration persists for at least 18 months after discontinuation of therapy.