Malouf-Sierra Jorge, Tarantino Umberto, García-Hernández Pedro A, Corradini Costantino, Overgaard Søren, Stepan Jan J, Borris Lars, Lespessailles Eric, Frihagen Frede, Papavasiliou Kyriakos, Petto Helmut, Aspenberg Per, Caeiro José Ramón, Marin Fernando
Internal Medicine, Hospital San Pablo, Barcelona, Spain.
Orthopaedic Surgery, University Tor Vergata, Rome, Italy.
J Bone Miner Res. 2017 May;32(5):1040-1051. doi: 10.1002/jbmr.3067. Epub 2017 Jan 26.
We present final results of a study comparing teriparatide 20 μg every day (QD) with risedronate 35 mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score ≤ -2.0 and 25OHD ≥9.2 ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100 mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean ± SD age: 77 ± 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p < 0.001) and FN (+1.96% versus -1.19%; p = 0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9 s; p = 0.045 for overall difference). Hip pain during TUG test by 100 mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3 mm, p = 0.033; -10.0 and -9.3 mm at 12 and 26 weeks, respectively; p = 0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p = 0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. © 2016 American Society for Bone and Mineral Research.
我们公布了一项研究的最终结果，该研究比较了在转子间髋部骨折手术后2周内开始使用的每日20μg特立帕肽（QD）与每周35mg利塞膦酸盐（QW）的疗效。骨密度T评分≤ -2.0且25羟维生素D≥9.2ng/mL的患者被随机分配接受为期26周的双盲治疗加钙和维生素D，随后接受为期52周的相同指定活性药物的开放标签治疗。主要终点是78周时腰椎（LS）骨密度相对于基线的变化。次要和探索性终点包括股骨近端骨密度变化、功能、髋部疼痛（Charnley评分和100mm视觉模拟量表[VAS]）、生活质量（简短形式-36）、放射学结果和安全性。数据采用重复测量混合模型（MMRM）和逻辑回归进行分析。共有224例患者被随机分组；171例（特立帕肽组：86例）纳入疗效分析（平均±标准差年龄：77±7.7岁，77%为女性）。平均基线LS、股骨颈（FN）和全髋（TH）T评分分别为-2.16、-2.63和-2.51。在78周时，与利塞膦酸盐相比，特立帕肽组的LS骨密度（+11.08%对+6.45%；p < 0.001）和FN骨密度（+1.96%对-1.19%；p = 0.003）显著增加更多，TH骨密度组间差异无统计学意义。在6、12、18和26周时，特立帕肽组的计时起立行走（TUG）测试明显更快（差异：-3.2至-5.9秒；总体差异p = 0.045）。在18周时，特立帕肽组通过100mm VAS测量的TUG测试期间的髋部疼痛明显更低（调整后差异：-11.3mm，p = 0.033；在12周和26周时分别为-10.0和-9.3mm；总体差异p = 0.079）。其他次要和探索性结果无差异。特立帕肽组出现2例新的髋部骨折，而利塞膦酸盐组为7例（p = 0.171），且特立帕肽组高钙血症和高尿酸血症更常见。总之，与利塞膦酸盐相比，78周的特立帕肽治疗显示LS和FN骨密度显著增加更多、疼痛减轻且TUG测试更快。© 2016美国骨与矿物质研究学会。
