Tromsø Endocrine Research Group, Department of Clinical Medicine, University of Tromsø, 9037 Tromsø, Norway.
Osteoporos Int. 2012 Jan;23(1):201-11. doi: 10.1007/s00198-011-1752-5. Epub 2011 Sep 10.
Vitamin D is widely used in osteoporosis treatment, although the optimal dose is not known. This 1-year clinical study among 297 women aged 50-80 years old showed that a vitamin D(3) dose of 6,500 IU/day was not better than the standard dose of 800 IU/day in improving bone mineral density (BMD) in the hip and spine.
The purpose of this study was to determine whether a high dose of vitamin D(3) was better than the standard dose in improving BMD and reducing bone turnover in postmenopausal women with reduced bone mass.
The study was a 1-year randomized double-blind controlled trial comparing high-dose vitamin D(3) with the standard dose. Postmenopausal women (n = 297) with a BMD T-score ≤ -2.0 in either lumbar spine (L2-4) or total hip were included and randomized to 6,500 IU vitamin D(3)/day (20,000 IU twice per week + 800 IU/day) or 800 IU vitamin D(3)/day (placebo twice per week + 800 IU/day). Both groups were given 1,000 mg elemental calcium/day. The primary endpoint was a change in BMD in total hip and lumbar spine (L2-4).
After 1 year, serum 25-hydroxyvitamin D (25(OH)D) increased [mean (SD)] from 71 (23) to 185 (34) nmol/l and from 71 (22) to 89 (17) nmol/l in the high- and standard-dose vitamin D groups, respectively. BMD at all measurement sites was unchanged or slightly improved with no significant differences between the groups. Although bone turnover was reduced in both groups, the more pronounced reduction in serum levels of the bone formation marker P1NP in the standard-dose group may indicate that this treatment was more efficient. Adverse events did not differ between the groups.
One year treatment with 6,500 IU vitamin D(3)/day was not better than 800 IU/day regarding BMD in vitamin D-replete postmenopausal women with reduced bone mass and was less efficient in reducing bone turnover.
维生素 D 广泛用于骨质疏松症的治疗，尽管其最佳剂量尚不明确。这项为期 1 年、纳入 297 名年龄在 50-80 岁之间的女性的临床研究显示，与 800IU/天的标准剂量相比，6500IU/天的维生素 D3 剂量并未改善髋部和脊柱的骨矿物质密度（BMD）。
本研究旨在确定对于骨质减少的绝经后女性，高剂量维生素 D3 是否优于标准剂量，从而改善 BMD 和减少骨转换。
该研究为为期 1 年的随机双盲对照试验，比较了高剂量维生素 D3 与标准剂量。纳入了 BMD T 评分≤-2.0 的绝经后女性（n=297），其腰椎（L2-4）或全髋骨密度降低，并将其随机分配至 6500IU 维生素 D3/天（20000IU 每周 2 次+800IU/天）或 800IU 维生素 D3/天（安慰剂每周 2 次+800IU/天）。两组均给予 1000mg 元素钙/天。主要终点为全髋和腰椎（L2-4）的 BMD 变化。
1 年后，血清 25-羟维生素 D（25（OH）D）分别从 71（23）增至 185（34）nmol/L 和从 71（22）增至 89（17）nmol/L，分别在高剂量和标准剂量维生素 D 组。所有测量部位的 BMD 无变化或略有改善，两组间无显著差异。尽管两组的骨转换均降低，但标准剂量组骨形成标志物 P1NP 血清水平的降低更为明显，这可能表明该治疗更为有效。两组的不良事件无差异。
在骨质减少且维生素 D 充足的绝经后女性中，1 年的 6500IU 维生素 D3 治疗并未改善 BMD，且在降低骨转换方面效率较低。
