Expired Study
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Madison, Wisconsin 53705


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.


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.


NCT ID:

NCT00062595


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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