Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.
Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.
复制标题
DOI：
10.1056/nejm200105103441904
复制
发表时间：
2001-05-10
影响因子：
158.5
通讯作者：
Mitlak, BH
中科院分区：
文献类型：
--
作者：
Neer, RM;Arnaud, CD;Mitlak, BH
背景资料：每日一次注射甲状旁腺激素或其氨基末端片段增加骨形成和骨量而不引起高钙血症，但其对fractions.Methods的影响是未知的：我们随机分配1637绝经后妇女与以前的椎骨骨折接受20或40微克甲状旁腺激素（1-34）或安慰剂，皮下注射的妇女每天。我们在基线和研究结束时拍摄了椎体X线片结果：安慰剂组中14%的妇女发生了新的椎骨骨折，20 μ g和40 μ g甲状旁腺激素组的妇女分别为5%和4%;与安慰剂组相比，20杯和40杯组骨折的相对风险分别为0.35和0.31（95%置信区间，0.22至0.55和0.19至0.50）。新的非椎骨脆性骨折发生在安慰剂组的6%和每个甲状旁腺激素组的3%（相对危险度分别为0.47和0.46 [95%置信区间为0.25 ~ 0.88和0.25 ~ 0.86]）。与安慰剂相比，20 μ g和40 μ g剂量的甲状旁腺激素使腰椎的骨密度增加了9和13个百分点，使股骨颈的骨密度增加了3和6个百分点; 40 μ g剂量使桡骨干的骨密度减少了2个百分点。两种剂量都使全身骨矿物质增加了2至4个百分点，比安慰剂多。甲状旁腺激素只有轻微的副作用（偶尔恶心和头痛）。结论：用甲状旁腺激素（1-34）治疗绝经后骨质疏松症可降低椎体和非椎体骨折的风险;增加椎体、股骨和全身骨密度;耐受性良好。40微克剂量比20微克剂量增加骨矿物质密度，但对骨折风险的影响相似，而且更有可能产生副作用。（N Engl J Med 2001;344：1434-41.）版权所有（C）2001马萨诸塞州医学会。
Background: Once-daily injections of parathyroid hormone or its amino-terminal fragments increase bone formation and bone mass without causing hypercalcemia, but their effects on fractures are unknown.Methods: We randomly assigned 1637 postmenopausal women with prior vertebral fractures to receive 20 or 40 mug of parathyroid hormone (1-34) or placebo, administered subcutaneously by the women daily. We obtained vertebral radiographs at base line and at the end of the study (median duration of observation, 21 months) and performed serial measurements of bone mass by dual-energy x-ray absorptiometry.Results: New vertebral fractures occurred in 14 percent of the women in the placebo group and in 5 percent and 4 percent, respectively, of the women in the 20-mug and 40-mug parathyroid hormone groups; the respective relative risks of fracture in the 20-mug and 40-mug groups, as compared with the placebo group, were 0.35 and 0.31 (95 percent confidence intervals, 0.22 to 0.55 and 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6 percent of the women in the placebo group and in 3 percent of those in each parathyroid hormone group (relative risk, 0.47 and 0.46, respectively [95 percent confidence intervals, 0.25 to 0.88 and 0.25 to 0.86]). As compared with placebo, the 20-mug and 40-mug doses of parathyroid hormone increased bone mineral density by 9 and 13 more percentage points in the lumbar spine and by 3 and 6 more percentage points in the femoral neck; the 40-mug dose decreased bone mineral density at the shaft of the radius by 2 more percentage points. Both doses increased total-body bone mineral by 2 to 4 more percentage points than did placebo. Parathyroid hormone had only minor side effects (occasional nausea and headache).Conclusions: Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated. The 40-mug dose increased bone mineral density more than the 20-mug dose but had similar effects on the risk of fracture and was more likely to have side effects. (N Engl J Med 2001;344:1434-41.) Copyright (C) 2001 Massachusetts Medical Society.