Osteoporosis
Conditions
Keywords
Menopause, Vitamin K, Bone turnover, Bone Density
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.
Interventions
DRUGphylloquinone (K1)
DRUGmenatetranone (MK4)
Sponsors
Eisai Co., Ltd.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion 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.
Countries
United States
Outcome results
None listed