Vitamin K and Bone Turnover in Postmenopausal Women - Full Text View

Vitamin K and Bone Turnover in Postmenopausal Women

This study has been completed.

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Eisai Limited
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00062595

Purpose

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
Osteoporosis	Drug: phylloquinone (K1) Drug: menatetranone (MK4)	Phase III

MedlinePlus related topics:

Osteoporosis

Drug Information available for:

Vitamin K Phytonadione Vitamin K1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Vitamin K and Bone Turnover in Postmenopausal Women

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062595

Locations


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 Limited

More Information

UW Osteoporosis Clincal Center and Research Program This link exits the ClinicalTrials.gov site

Study ID Numbers:	VITKBONE
First Received:	June 9, 2003
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00062595
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Menopause

Vitamin K

Bone turnover

Study placed in the following topic categories:

Antiplasmin

Musculoskeletal Diseases

Vitamin K

Osteoporosis

Bone Diseases, Metabolic

Vitamin K 1

Bone Diseases

Menopause

Additional relevant MeSH terms:

Fibrin Modulating Agents

Antifibrinolytic Agents

Coagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Growth Substances

Vitamins

Hematologic Agents

Physiological Effects of Drugs

Micronutrients

Hemostatics

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008