Randomized controlled study on the prevention of osteoporotic fractures (OF study): a phase IV clinical study of 15-mg menatetrenone capsules

Inoue T, Fujita T, Kishimoto H, et al. · Journal of Bone and Mineral Metabolism

The one large trial in this literature was null: across 4,378 women, new vertebral fractures over 36 months did not differ between MK-4 plus calcium and calcium alone in either stratum, and the 48-month clinical-fracture difference was not significant. Only women with at least five baseline vertebral fractures showed lower risk, and adverse events were more frequent on MK-4.

Population

Osteoporotic postmenopausal women aged 50 and over, stratified by baseline vertebral fracture, 36-48 months

Intervention

Menatetrenone (MK-4) 45 mg/day plus calcium

Comparator

Calcium supplement alone

Limitations

Open-label with blinded outcome evaluation and no placebo; the positive finding is a subgroup of the most severely affected participants; MK-4 at 45 mg/day, not MK-7.