Unnanuntana Aasis, Laohaprasitiporn Panai, Jarusriwanna Atthakorn
Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Prannok Road, Bangkoknoi, Bangkok, 10700, Thailand.
Arch Osteoporos. 2017 Dec;12(1):27. doi: 10.1007/s11657-017-0321-8. Epub 2017 Mar 10.
The appropriate time to initiate bisphosphonate treatment after a fragility fracture has not yet been established. In this study, we found no significant differences in short-term functional recovery between femoral neck fracture patients who received bisphosphonate treatment at 2 versus 12 weeks after hemiarthroplasty.
Bisphosphonate is the mainstay therapy for prevention and treatment of osteoporosis. The aim of this study was to investigate the effect of bisphosphonate initiation on short-term functional recovery in femoral neck fracture patients at 2 versus 12 weeks after hemiarthroplasty.
One hundred patients were randomly allocated into two groups in a parallel group designed, randomized, controlled trial. Both groups received risedronate 35 mg/week at either 2 or 12 weeks after hemiarthroplasty. All patients received calcium and vitamin D supplementation. Functional recovery was assessed by de Morton Mobility Index, Barthel Index, EuroQol 5D, visual analog scale, 2-min walk test, and timed get-up-and-go test at 2 weeks, 3 months, and 1 year after surgery.
At the 3-month follow-up, all functional outcome measures showed significant improvement in both groups. There were no statistically significant differences in any of the functional outcomes between groups at both the 3-month and 1-year follow-ups. Although patients who received bisphosphonate initiation at week 2 had lower serum calcium level at 3 months and more overall adverse events than patients in the week 12 group, no patients in either group discontinued their prescribed medications.
While underpowered, the findings of this study suggest that there were no significant differences in short-term functional recovery or significant adverse events between the two bisphosphonate groups. Thus, the initiation of bisphosphonate therapy may be considered as early as 2 weeks after femoral neck fracture. It is important that low serum calcium and vitamin D status must be corrected with calcium and vitamin D supplementation prior to or at the time of bisphosphonate initiation.
This study was registered in the database via the Protocol Registration and Results System (PRS) (NCT02148848).
脆性骨折后启动双膦酸盐治疗的合适时机尚未确定。在本研究中,我们发现半髋关节置换术后2周与12周接受双膦酸盐治疗的股骨颈骨折患者在短期功能恢复方面无显著差异。
双膦酸盐是预防和治疗骨质疏松症的主要疗法。本研究的目的是调查半髋关节置换术后2周与12周启动双膦酸盐治疗对股骨颈骨折患者短期功能恢复的影响。
在一项平行组设计、随机、对照试验中,将100例患者随机分为两组。两组均在半髋关节置换术后2周或12周接受每周35毫克利塞膦酸盐治疗。所有患者均补充钙和维生素D。在术后2周、3个月和1年时,通过德莫顿活动指数、巴氏指数、欧洲五维健康量表、视觉模拟量表、2分钟步行试验和定时起立行走试验评估功能恢复情况。
在3个月随访时,两组的所有功能结局指标均显示出显著改善。在3个月和1年随访时,两组之间的任何功能结局均无统计学显著差异。尽管在术后2周启动双膦酸盐治疗的患者在3个月时血清钙水平较低且总体不良事件比12周组的患者多,但两组均无患者停止服用规定药物。
尽管本研究样本量不足,但研究结果表明,两个双膦酸盐组在短期功能恢复或显著不良事件方面无显著差异。因此,股骨颈骨折后最早可在2周时考虑启动双膦酸盐治疗。重要的是,在启动双膦酸盐治疗之前或之时,必须通过补充钙和维生素D来纠正低血清钙和维生素D状态。
本研究通过方案注册和结果系统(PRS)在数据库中注册(NCT02148848)。