Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks
Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks
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DOI：
10.2106/jbjs.15.01217
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发表时间：
2016-11-16
影响因子：
5.3
通讯作者：
Marin, Fernando
中科院分区：
文献类型：
--
作者：
Aspenberg, Per;Malouf, Jorge;Marin, Fernando
背景：骨质疏松症药物可能会影响骨折愈合。因此，我们研究了特立帕肽与利塞膦酸钠对股骨粗隆间髋部骨折后恢复的影响。方法：该研究是一项随机、多中心、主动对照、为期 78 周的试验，比较低创伤股骨转子间髋部骨折（AO/OTA 31-A1 或31-A2)。主要纳入标准是骨矿物质密度 T 分数 = 9.2 ng/mL。在前 26 周内，患者以双盲方式接受研究药物治疗，包括口服或注射安慰剂以及钙和维生素 D。报告了次要（定时起立 [TUG] 测试、髋部疼痛、简式 [SF]-36 健康状况和安全性）和探索性（放射学结果和行走能力）26 周终点。结果：在随机分组的 224 名患者中，171 名（86 名特立帕肽，85 名利塞膦酸盐）纳入分析。平均年龄为 77 +/- 8 岁，77% 为女性，26% 有低创伤性骨折史。特立帕肽组在第 6、12、18 和 26 周时在更短的时间内完成了 TUG 测试（差异分别为 25.7、-4.4、-3.1 和 -3.1 秒；总体差异 p = 0.021）。他们还报告说，在 12 周和 18 周的 TUG 测试后，视觉模拟量表上的疼痛立即减轻（调整后的绝对差异分别为 10.6 和 11.9 毫米；p < 0.05）。随访期间 SF-36 评分、Charnley 髋部疼痛评分、行走能力或助行器的使用没有显着组间差异。第 6、12 和 26 周时的放射线愈合、植入物的机械故障（特立帕肽，7 例；利塞膦酸钠，8）、复位丢失（特立帕肽，2 例；利塞膦酸钠，4）和骨不连（0 例）没有显着差异。特立帕肽更容易出现轻度高钙血症和高尿酸血症。结论：与利塞膦酸钠相比，特立帕肽可减轻疼痛，并缩短 6 至 26 周内完成 TUG 测试的时间。其他骨折恢复结果相似。应谨慎解释结果，因为这些是次要终点。
Background: Osteoporosis drugs might affect fracture-healing. We therefore studied the effects of teriparatide in comparison with risedronate on recovery after pertrochanteric hip fractures.Methods: The study was a randomized, multicenter, active-controlled, 78-week trial comparing teriparatide (20 mg/day) with risedronate (35 mg/week) initiated within 2 weeks after fixation of a low-trauma pertrochanteric hip fracture (AO/OTA 31-A1 or 31-A2). The main inclusion criteria were a bone mineral density T-score of = 9.2 ng/mL. During the first 26 weeks, patients received study medication with oral or injectable placebo plus calcium and vitamin D in a double-blinded fashion. Secondary (Timed Up-and-Go [TUG] test, hip pain, Short Form [SF]-36 health status, and safety) and exploratory (radiographic outcomes and ability to walk) 26-week end points are reported.Results: Of the 224 patients who were randomized, 171 (86 teriparatide, 85 risedronate) were included in the analysis. The mean age was 77 +/- 8 years, 77% were female, and 26% had a prior history of low-trauma fracture. The teriparatide group completed the TUG test in a shorter time at 6, 12, 18, and 26 weeks (differences of 25.7, -4.4, -3.1, and -3.1 seconds, respectively; p = 0.021 for the overall difference). They also reported less pain on a visual analog scale immediately after the TUG test at 12 and 18 weeks (adjusted absolute differences of 10.6 and 11.9 mm, respectively; p < 0.05). There were no significant between-group differences in the SF-36 score, Charnley hip pain score, ability to walk, or use of walking aids during follow-up. Radiographic healing at 6, 12, and 26 weeks, mechanical failure of the implant (teriparatide, 7; risedronate, 8), loss of reduction (teriparatide, 2; risedronate, 4), and nonunion (0 cases) were not significantly different. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide.Conclusions: Teriparatide was associated with less pain and a shorter time to complete the TUG test between 6 and 26 weeks compared with risedronate. Other fracture-recovery outcomes were similar. The results should be interpreted with caution as these were secondary end points.