Glendenning Paul, Chew Gerard T, Seymour Hannah M, Gillett Melissa J, Goldswain Peter R, Inderjeeth Charles A, Vasikaran Samuel D, Taranto Mario, Musk Alexander A, Fraser William D
Department of Core Clinical Pathology and Biochemistry, Pathwest Royal Perth Hospital, Perth, Western Australia 6000, Australia.
Bone. 2009 Nov;45(5):870-5. doi: 10.1016/j.bone.2009.07.015. Epub 2009 Jul 23.
Vitamin D insufficiency is commonly associated with hip fracture. However, the equipotency of ergocalciferol and cholecalciferol supplementation in this patient group has not been studied in a randomized trial using high-performance liquid chromatography (HPLC) measurement of serum 25-hydroxyvitamin D (25OHD). The objective of this study was to determine if ergocalciferol and cholecalciferol are equipotent therapies in vitamin D-insufficient hip fracture patients. Ninety five hip fracture inpatients with vitamin D insufficiency (25OHD<50 nmol/L) were randomized, double-blind, to treatment with ergocalciferol 1000 IU/day (n=48) or cholecalciferol 1000 IU/day (n=47) for three months. All participants were also given a placebo matching the alternative treatment to maintain blinding of treatment allocation. The primary endpoint was total serum 25OHD measured by HPLC. Secondary endpoints included 25OHD measured by radioimmunoassay (RIA), intact parathyroid hormone (iPTH), and bioactive (1-84) whole PTH (wPTH). Seventy patients (74%) completed the study with paired samples for analysis. Cholecalciferol supplementation resulted in a 31% greater increase in total HPLC-measured 25OHD (p=0.010) and 52% greater rise in RIA-measured 25OHD (p<0.001) than supplementation with an equivalent dose of ergocalciferol. Changes in iPTH and wPTH were not significantly different between calciferol treatments (p>0.05). In vitamin D-insufficient hip fracture patients, supplementation with cholecalciferol 1000 IU/day for three months was more effective in increasing serum 25OHD than an equivalent dose of ergocalciferol. However, the lack of difference in PTH lowering between calciferol treatments raises questions about the biological importance of this observation.
维生素D缺乏通常与髋部骨折相关。然而，在使用高效液相色谱法（HPLC）测定血清25-羟基维生素D（25OHD）的随机试验中，尚未研究该患者群体补充麦角钙化醇和胆钙化醇的等效性。本研究的目的是确定麦角钙化醇和胆钙化醇在维生素D缺乏的髋部骨折患者中是否为等效疗法。95例维生素D缺乏（25OHD<50 nmol/L）的髋部骨折住院患者被随机、双盲分为两组，分别接受每日1000 IU麦角钙化醇治疗（n=48）或每日1000 IU胆钙化醇治疗（n=47），为期三个月。所有参与者还接受了与替代治疗相匹配的安慰剂，以维持治疗分配的盲法。主要终点是通过HPLC测定的血清总25OHD。次要终点包括通过放射免疫测定法（RIA）测定的25OHD、完整甲状旁腺激素（iPTH）和生物活性（1-84）全甲状旁腺激素（wPTH）。70例患者（74%）完成了研究并提供了配对样本用于分析。与补充等效剂量的麦角钙化醇相比，补充胆钙化醇使通过HPLC测定的总25OHD增加了31%（p=0.010），使通过RIA测定的25OHD升高了52%（p<0.001）。两种钙化醇治疗之间iPTH和wPTH的变化无显著差异（p>0.05）。在维生素D缺乏的髋部骨折患者中，每日补充1000 IU胆钙化醇三个月在提高血清25OHD方面比等效剂量的麦角钙化醇更有效。然而，两种钙化醇治疗在降低PTH方面缺乏差异，这引发了对这一观察结果生物学重要性的质疑。
