Trial Information

Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)

Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women. It
is a systemic disease characterized by low bone mass and deterioration of bone
microarchitecture, resulting in bone fragility and an increased risk of fractures. One in
six women over the age of 50 have osteoporosis. The lifetime risk of an osteoporotic
fracture for an average 50 year-old Canadian woman is >40%. The annual health care costs
for osteoporotic fractures in Canada have been estimated to exceed $1.3 billion.

Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures.
Vitamin K is a co-factor of gamma-glutamyl carboxylase, an enzyme that catalyzes the
gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin.
Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo
studies in animals. Vitamin K levels are low in individuals with osteoporosis and in
patients with osteoporotic fractures. The few studies examining vitamin K supplementation
in humans have showed promising results with no significant side effects, but these studies
had significant methodological shortcomings such as inadequate sample size and lack of
randomization.

The primary objective of our study is to examine whether vitamin K supplementation will
increase bone mineral density in postmenopausal women with osteopenia. Our secondary
objectives are to examine the possible adverse effects from long-term vitamin K
supplementation, to investigate whether vitamin K will decrease risk of fractures and to
determine if vitamin K affects quality of life. Our hypotheses are that vitamin K increases
bone mineral density in postmenopausal women, and that there are no significant adverse
effects from vitamin K supplementation.