Summary

We conducted a randomized placebo-controlled double-blinded clinical trial of MK-7 or placebo daily for 3 years in postmenopausal women with osteopenia. BMD decreased at all sites without differences between the MK-7 and placebo-treated women. Changes in bone turnover markers and microstructure were similar between the two groups.

Introduction

Vitamin K is a cofactor in the carboxylation of osteocalcin (OC) and carboxylated OC promotes mineralization of bone. Clinical studies suggest that vitamin K2 prevents bone loss. The aim of the study was to investigate the effect of vitamin K2 as an add-on to calcium and vitamin D supplementation on osteocalcin, bone mass, and microarchitecture in postmenopausal women.

Methods

We conducted a randomized placebo-controlled double-blinded clinical trial, including 142 postmenopausal women with osteopenia who received vitamin K2 (375 μg MK-7) or placebo daily for 3 years. Both groups received vitamin D3 (38 μg/day) and calcium (800 mg/day). We measured bone turnover markers in serum and bone mineral density and microarchitecture by DXA and HRpQCT.

Results

Undercarboxylated osteocalcin decreased in the MK-7-group (− 65.2 ± 23.5%) (mean ± SD) compared with the placebo group (− 0.03 ± 38.5%), p < 0.01 after 1 year. After 3 years, aBMD decreased at all sites without differences between the MK-7 and placebo-treated women (p > 0.09). aBMD decreased at the total hip by 1.5 ± 2.5% and 2.4 ± 2.7% in the MK-7 and the placebo groups, respectively, at the femoral neck by 1.5 ± 3.5% and 1.0 ± 5.0% in the MK-7 and the placebo groups, respectively, and at the lumbar spine by 1.8 ± 3.9% and 1.1 ± 3.1% in the MK-7 and the placebo groups, respectively. Changes in bone turnover markers were also similar between the two groups.We have previously reported improved microarchitecture with MK-7 after 1 year. However, changes in microstructure over 3 years were similar between the two groups, as assessed by both HRpQCT and DXA trabecular bone score.

Conclusion

Treatment with MK-7 375 μg daily as an add-on to calcium and vitamin D increased carboxylation of osteocalcin. However, treatment of postmenopausal women with osteopenia for 3 years did not affect biochemical markers of bone turnover, bone mineral density, or bone microarchitecture.

Trial registration

The study was registered at Clinicaltrial.gov:NCT01922804.

中文翻译：

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维生素MK-7对绝经后骨质疏松妇女骨矿物质密度和微结构的影响，这项为期3年的随机，安慰剂对照临床试验

概要

我们对绝经后患有骨质减少的妇女进行了一项为期3年的每日安慰剂对照双盲MK-7或安慰剂对照临床试验，为期3年。在所有部位，BMD均下降，MK-7和安慰剂治疗的女性之间无差异。两组之间的骨转换标志物和微观结构的变化相似。

介绍

维生素K是骨钙素（OC）羧化的辅助因子，羧化OC促进骨矿化。临床研究表明，维生素K2可以防止骨质流失。这项研究的目的是研究维生素K2作为钙和维生素D补充剂的补充对绝经后妇女骨钙素，骨量和微结构的影响。

方法

我们进行了一项随机安慰剂对照的双盲临床试验，包括142名绝经后骨质减少的妇女，她们每天接受维生素K2（375μgMK-7）或安慰剂治疗3年。两组均接受维生素D3（38微克/天）和钙（800毫克/天）。我们通过DXA和HRpQCT测量了血清，骨矿物质密度和微结构中的骨转换标记。

结果

与安慰剂组（-0.03±38.5％）相比，MK-7组的羧化骨钙蛋白不足（-65.2±23.5％）（平均值±SD）降低，p  <0.01。3年后，所有部位的aBMD均下降，MK-7和安慰剂治疗的女性之间无差异（p > 0.09）。在MK-7和安慰剂组中，全髋关节的aBMD分别降低1.5±2.5％和2.4±2.7％，在MK-7和安慰剂组中，股骨颈的aBMD分别降低1.5±3.5％和1.0±5.0％ MK-7组和安慰剂组的腰椎和腰椎分别为1.8±3.9％和1.1±3.1％。两组之间的骨转换标志物的变化也相似。我们之前曾报道过1年后MK-7改善了微结构。然而，根据HRpQCT和DXA小梁骨评分，两组之间3年的显微结构变化相似。

结论

每天用MK-7 375μg作为钙和维生素D的添加剂，可以增加骨钙素的羧化作用。但是，绝经后妇女接受骨质疏松症治疗3年并没有影响骨转换，骨矿物质密度或骨微结构的生化指标。

试用注册

该研究已在Clinicaltrial.gov:NCT01922804上注册。