Vitamin K and Bone Turnover in Postmenopausal Women - Tabular View

Tracking Information
First Received Date ^ICMJE	June 9, 2003
Last Updated Date	November 29, 2005
Start Date ^ICMJE	September 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00062595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Vitamin K and Bone Turnover in Postmenopausal Women
Official Title ^ICMJE	Vitamin K and Bone Turnover in Postmenopausal Women
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Osteoporosis
Intervention ^ICMJE	Drug: phylloquinone (K1) Drug: menatetranone (MK4)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	375
Completion Date	October 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00062595
Responsible Party
Study ID Numbers ^ICMJE	VITKBONE
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE	Eisai Limited
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP