Division of Endocrinology, Department of Medicine, McGill University, Montreal, Quebec, Canada.
Ann Pharmacother. 2011 May;45(5):561-8. doi: 10.1345/aph.1P439. Epub 2011 Apr 26.
Suboptimal vitamin D status is common in elderly individuals. However, the extent of vitamin D inadequacy in men and women being treated for osteoporosis in a family practice setting has not been well characterized.
To describe the distribution of serum 25-hydroxyvitamin D (25-[OH] D) in Canadian men and postmenopausal women with osteoporosis taking 400 IU or less of vitamin D daily and to evaluate the safety, tolerability, and impact of vitamin D(3) supplementation 400 IU daily taken concurrently with alendronate sodium 70 mg weekly.
This was a prospective, single-cohort, open-label, multicenter study. Community-dwelling men and postmenopausal women with osteoporosis were recruited at 197 sites across Canada. Patients received vitamin D(3) 400 IU/day supplementation coadministered with alendronate 70 mg/wk for 16 weeks. The primary outcome was the distribution of serum 25-(OH) D at baseline. Secondary outcome measures included changes from baseline in serum 25-(OH) D levels, adherence to study treatments, and incidence of treatment-related adverse events (AEs).
Of the 681 patients included in the analysis, 485 (71.2%) completed the study. Patients were predominantly female (83.1%) with a mean (SD) age of 67.6 (10.7) years. At baseline, mean (SD) serum 25-(OH) D concentration was 25.4 (9.9) ng/mL and 68.0% of the patients had inadequate (less than 30 ng/mL) vitamin D status. At week 16, concentrations increased by 35.1% to 31.2 (9.2) ng/mL (p < 0.001) and the proportion of patients with inadequate 25-(OH) D levels was reduced to 47.0%. Adherence to the treatment regimen was high (greater than 95%). Gastrointestinal disorders were the most frequently reported (6.9%) treatment-related AEs.
About two thirds of patients previously diagnosed with osteoporosis have inadequate vitamin D status. A treatment regimen consisting of alendronate 70 mg/wk administered with daily vitamin D(3) 400 IU supplementation significantly increased patients' serum 25-(OH) D levels, but 47% did not achieve optimal levels. These results support both the National Osteoporosis Foundation and Osteoporosis Canada recommendations for higher vitamin D supplement doses (at least 800 IU daily) in osteoporotic patients receiving pharmacologic therapy for osteoporosis and for monitoring their serum 25-(OH) D response.
维生素 D 状态不佳在老年人中很常见。然而，在家庭医疗环境中接受骨质疏松治疗的男性和女性中，维生素 D 不足的程度尚未得到充分描述。
描述每天接受 400IU 或更少维生素 D 治疗的加拿大男性和绝经后骨质疏松症女性的血清 25-羟维生素 D（25-[OH] D）分布情况，并评估维生素 D（3）补充剂每天 400IU 与每周一次阿仑膦酸钠 70mg 同时使用的安全性、耐受性和影响。
这是一项前瞻性、单队列、开放标签、多中心研究。在加拿大的 197 个地点招募了患有骨质疏松症的社区居住男性和绝经后女性。患者接受维生素 D（3）400IU/天的补充治疗，并同时给予阿仑膦酸钠 70mg/周，治疗 16 周。主要结局是基线时血清 25-（OH） D 的分布。次要结局包括血清 25-（OH） D 水平从基线的变化、对研究治疗的依从性以及与治疗相关的不良事件（AE）的发生率。
在纳入分析的 681 名患者中，有 485 名（71.2%）完成了研究。患者主要为女性（83.1%），平均（SD）年龄为 67.6（10.7）岁。基线时，平均（SD）血清 25-（OH） D 浓度为 25.4（9.9）ng/mL，68.0%的患者维生素 D 状态不足（低于 30ng/mL）。在第 16 周时，浓度增加了 35.1%，达到 31.2（9.2）ng/mL（p < 0.001），维生素 D 不足的患者比例降至 47.0%。治疗方案的依从性很高（大于 95%）。胃肠道疾病是最常报告的（6.9%）与治疗相关的 AE。
以前诊断为骨质疏松症的患者中，约有三分之二的患者维生素 D 状态不足。每周一次给予阿仑膦酸钠 70mg 与每天补充维生素 D（3）400IU 的联合治疗方案显著增加了患者的血清 25-（OH） D 水平，但仍有 47%的患者未达到最佳水平。这些结果支持国家骨质疏松基金会和加拿大骨质疏松症协会的建议，即对于接受骨质疏松症药物治疗的骨质疏松症患者，应补充更高剂量的维生素 D（每日至少 800IU），并监测其血清 25-（OH） D 反应。
