Vitamin K and Bone Turnover in Postmenopausal Women

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID
NCT00062595
Run by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed
375
Starts
2000-09-01
Expected to finish
2004-10-01
Last updated by the study team
2016-05-17

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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