The Effect of Vitamin K2 on Bone Turnover

What Was Tested

This registered phase 4 trial tested Vitamin D, K2, Magnesium and Zinc for osteoporosis and bone density.

To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis.

One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin.

The registry classes the interventions as drug.

Who Took Part

131 actual participants took part.

It was open to women only aged from 49 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ); patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, serm, active vitamin d3, or warfarin) were excluded.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The osteoporosis and bone density participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Everyone knew when Vitamin D, K2, Magnesium and Zinc was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-02-01 with completion listed for 2013-01.

It ran at 4 sites in Japan (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Gamma-carboxylation.

It also tracked 1 secondary outcome, for example Bone turnover marker.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vitamin D, K2, Magnesium and Zinc in 131 people with osteoporosis and bone density.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, Osteoporosis and bone density research.