Shigenobu Keiichi, Hashimoto Tomoyuki, Kanayama Masahiro, Ohha Humihiro, Yamane Shigeru
Department of Orthopedics, KKR Sapporo Medical Center, Japan.
Department of Orthopedics, Hakodate Central General Hospital, Japan.
Bone Rep. 2019 Jul 25;11:100217. doi: 10.1016/j.bonr.2019.100217. eCollection 2019 Dec.
We conducted a randomized control study to compare the effects of pain, QOL, bone metabolism and fracture healing by administering bisphosphonate (BP) or weekly teriparatide preparation (W-TPTD) to 43 patients (5 males and 38 females) with fresh spinal vertebral compression fractures for osteoporosis. The patients were aged between 61 and 93 years old (mean 78.1 years). In principle, a MRI was used for any diagnosis of new vertebral fractures. From this study, lumbar spine bone mineral density (BMD), after 24 weeks of administration, showed a significant increase (p < 0.05) in both the BP group (mean 5.3%) and in the W-TPTD group (mean 4.9%). The W-TPTD group showed a better Roland-Morris disability Questionnaire (RDQ) improvement throughout the whole period of the study compared with the BP group, the difference was statistically significant after 24 weeks of administration (p < 0.05). The EuroQol 5 dimensions (EQ-5D) and visual analogue scale (VAS) score significantly improved over time in both groups (p < 0.05). The fracture-healing rate was observed in 45% of the BP group and 73% of the W-TPTD group at Week 12, and a statistically significant higher fracture-healing rate was obtained in the W-TPTD group compared to the BP group (p < 0.05). The mean time of fracture-healing was 3.9 months for the BP group and 2.8 months in the W-TPTD group. Statistically significant faster fracture-healing was observed in the W-TPTD group (p < 0.05). At Week 12 and Week 24, P1NP was significantly higher in the W-TPTD group compared to that of the BP group (p < 0.05). TRACP-5b showed no major fluctuations during the study period in either group. These results suggest that W-TPTD may promote better fracture healing of any new osteoporotic vertebral compression fractures compared with a BP.
我们进行了一项随机对照研究，以比较双膦酸盐（BP）或每周一次的特立帕肽制剂（W-TPTD）对43例（5例男性和38例女性）骨质疏松性新鲜脊柱椎体压缩骨折患者疼痛、生活质量、骨代谢和骨折愈合的影响。患者年龄在61至93岁之间（平均78.1岁）。原则上，任何新椎体骨折的诊断均使用MRI。在本研究中，给药24周后，BP组（平均5.3%）和W-TPTD组（平均4.9%）的腰椎骨密度（BMD）均显著增加（p<0.05）。与BP组相比，W-TPTD组在整个研究期间的罗兰-莫里斯功能障碍问卷（RDQ）改善情况更好，给药24周后差异有统计学意义（p<0.05）。两组的欧洲五维健康量表（EQ-5D）和视觉模拟量表（VAS）评分均随时间显著改善（p<0.05）。在第12周时，BP组的骨折愈合率为45%，W-TPTD组为73%，与BP组相比，W-TPTD组的骨折愈合率在统计学上显著更高（p<0.05）。BP组骨折愈合的平均时间为3.9个月，W-TPTD组为2.8个月。W-TPTD组的骨折愈合在统计学上明显更快（p<0.05）。在第12周和第24周时，W-TPTD组的I型前胶原氨基端前肽（P1NP）显著高于BP组（p<0.05）。在研究期间，两组的抗酒石酸酸性磷酸酶5b（TRACP-5b）均无重大波动。这些结果表明，与BP相比，W-TPTD可能促进任何骨质疏松性椎体压缩骨折更好地愈合。
