Vitamin K and Bone Turnover in Postmenopausal Women

May 16, 2016 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Osteoporosis Clinical Research Prog.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

June 9, 2003

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK58363 (completed 2005)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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