NCT00062595

Vitamin K and Bone Turnover in Postmenopausal Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (planned)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	phylloquinone (K1)
DRUG	menatetranone (MK4)

Timeline

• Start date: 2000-09-01
• Completion: 2004-10-01
• First posted: 2003-06-12
• Last updated: 2016-05-17

Locations

1 site across 1 country: United States