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Vitamin K and Bone Turnover in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00062595
Recruitment Status : Completed
First Posted : June 12, 2003
Last Update Posted : May 17, 2016
Eisai Co., Ltd.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: phylloquinone (K1) Drug: menatetranone (MK4) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Vitamin K and Bone Turnover in Postmenopausal Women
Study Start Date : September 2000
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062595

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United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Research Prog.
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eisai Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00062595    
Other Study ID Numbers: DK58363 (completed 2005)
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Vitamin K
Bone turnover
Bone Density
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin K 1
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs