Vitamin K and Bone Turnover in Postmenopausal Women

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Eisai Co., Ltd.
• Treatments: Vitamin K; Vitamin K 1; Vitamins

Criteria

• Female, 5 years postmenopause.

• Ambulatory.

• Community dwelling.

• Able to ingest calcium and vitamin D supplements.

• Willing to restrict vitamin K intake.

• Stable thyroid dose if appropriate.

• No history of hyperthyroidism, hyperparathyroidism or other metabolic bone diseases.

• Absence of hardware in hip and spine.

• History of malignancy within the last five years.

• Not currently using coumadin or warfarin.

• Vitamin D supplements must be less than 800 IU daily.

• Have not used estrogen or other bone-altering medications (see list in study description) within the last year.

• No history of liver disease or malabsorption.

• No known allergy to vitamin K.

• Have not participated in an investigational drug trial within the last month.