Vitamin K and Bone Turnover in Postmenopausal Women
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study
supplementation effects on bone turnover and bone density. Women at least 5 years
postmenopause with normal bone density who do not use estrogen therapy or the following
medications may be eligible:
alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel),
zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin
(Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will
take calcium and vitamin D (Citracal) twice a day for the first two months and through-out
the study. After the first two months, subjects are randomized to the K1, MK4 or placebo
groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at
each visit and bone density is performed at 3 study visits.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)