Skip to main content
OpenTrials
Completed

NCT Number: NCT00062595

Vitamin K and Bone Turnover in Postmenopausal Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Wisconsin Osteoporosis Clinical Research Prog.

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

phylloquinone (K1)

Drug

menatetranone (MK4)

Drug

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Eisai Co., Ltd.

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
Jun 12, 2003
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.