Vitamin K and Bone Turnover in Postmenopausal Women

This study has been completed.

First Received on June 9, 2003. Last Updated on March 17, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:	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

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:

MedlinePlus related topics: Bone Density Osteoporosis Vitamin K

Drug Information available for: Vitamin K1 Vitamin K Phytonadione

U.S. FDA Resources

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

Additional Information:

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

No publications provided

ClinicalTrials.gov 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):

Menopause
Vitamin K
Bone turnover

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin K 1
Vitamin K
Vitamins
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012