Mak Jenson C S, Mason Rebecca, Klein Linda, Cameron Ian D
Department of Geriatric Medicine, Northern Sydney Central Coast Area Health Service, Gosford Hospital, Gosford, NSW, Australia ; Department of General Medicine, Mater Hospital, Sydney, New South Wales, Australia ; Rehabilitation Studies Unit, Sydney Medical School, University of Sydney, New South Wales, Australia.
Geriatr Orthop Surg Rehabil. 2011 May;2(3):94-9. doi: 10.1177/2151458511406723.
Hypovitaminosis D is particularly common among older people with a proximal femoral (hip) fracture and has been linked with poorer lower extremity functioning, falls, and fractures. There is evidence that disability severity and fall rates may be reduced by adequate vitamin D replacement. However, the ideal regimen for vitamin D administration to have these benefits in older people who have been in the hospital has not been established. This randomized controlled trial will investigate the effects of an oral vitamin D loading dose with maintenance oral vitamin D and calcium on lower extremity function (gait velocity), correction of hypovitaminosis D, falls, and fractures among older people after hip fracture surgery. The cost-effectiveness of the REVITAHIP program from the health and community service provider's perspective will also be established, as will predictors of adherence with the treatment. A total of 450 older people who have recently had a hip fracture requiring surgical intervention will be screened to achieve 250 participants for the study. Participants will have no medical contraindications to vitamin D replacement. The primary outcome measure will be mobility-related disability as measured with the 2.4-m gait velocity test. Secondary measures will be 25-hydroxyvitamin D (25-OHD) levels at 2, 4, and 26 weeks, number of falls and fractures, and additional measures of mobility, disability, quality of life, health system and community-service contact, adherence to the intervention, and adverse events. After surgical fixation and being deemed medically stable, participants will be randomly allocated to an intervention or placebo-control group. Participants of the intervention group will receive initial oral 250 000 IU (5 × 50 000 IU) vitamin D3 tablets. Both groups will receive oral maintenance vitamin D3 and calcium and will follow the usual hip fracture rehabilitation pathway. The study will determine the impact of a vitamin D loading dose on mobility-related disability in older people following hip fracture and will discuss the efficacy and cost-effectiveness of a loading dose vitamin D replacement more generally. The results will have direct implications for future use of vitamin D therapy for this high-risk group.
维生素D缺乏症在股骨近端（髋部）骨折的老年人中尤为常见，并且与下肢功能较差、跌倒及骨折有关。有证据表明，充足的维生素D补充可降低残疾严重程度和跌倒发生率。然而，对于住院的老年人而言，能带来这些益处的理想维生素D给药方案尚未确立。这项随机对照试验将研究口服维生素D负荷剂量联合维持剂量的口服维生素D及钙剂对髋部骨折手术后老年人下肢功能（步速）、维生素D缺乏症的纠正、跌倒及骨折的影响。还将从健康和社区服务提供者的角度确定REVITAHIP项目的成本效益，以及治疗依从性的预测因素。总共将筛查450名近期发生髋部骨折且需要手术干预的老年人，以招募250名参与者进行研究。参与者不存在维生素D补充的医学禁忌证。主要结局指标将是通过2.4米步速测试衡量的与活动能力相关的残疾情况。次要指标将包括第2、4和26周时的25-羟维生素D（25-OHD）水平、跌倒和骨折的次数，以及活动能力、残疾、生活质量、卫生系统和社区服务接触、干预依从性及不良事件的其他指标。在手术固定且被判定医学状况稳定后将参与者随机分配至干预组或安慰剂对照组。干预组参与者将口服初始剂量的250 000国际单位（5×50 000国际单位）维生素D3片。两组都将口服维持剂量的维生素D3和钙剂，并遵循常规的髋部骨折康复路径。该研究将确定维生素D负荷剂量对髋部骨折后老年人与活动能力相关残疾的影响，并更全面地探讨负荷剂量维生素D补充的疗效和成本效益。研究结果将对这一高危人群未来使用维生素D疗法有直接影响。
