Vitamin K and Bone Turnover in Postmenopausal Women

This study has been completed.
Eisai Limited
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: June 9, 2003
Last updated: March 17, 2010
Last verified: March 2010

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.

Condition Intervention Phase
Drug: phylloquinone (K1)
Drug: menatetranone (MK4)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Vitamin K and Bone Turnover in Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 375
Study Start Date: September 2000
Estimated Study Completion Date: October 2004

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00062595

United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Research Prog.
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Eisai Limited
  More Information

Additional Information:
No publications provided Identifier: NCT00062595     History of Changes
Other Study ID Numbers: DK58363 (completed 2005)
Study First Received: June 9, 2003
Last Updated: March 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Vitamin K
Bone turnover

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin K 1
Vitamin K
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Therapeutic Uses processed this record on April 17, 2014