Vitamin K and Bone Turnover in Postmenopausal Women
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: phylloquinone (K1) (Drug); menatetranone (MK4) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Clinical Details
Official title: Vitamin K and Bone Turnover in Postmenopausal Women
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
University of Wisconsin Osteoporosis Clinical Research Prog., Madison, Wisconsin 53705, United States
Additional Information
UW Osteoporosis Clincal Center and Research Program
Starting date: September 2000
Ending date: October 2004
Last updated: November 29, 2005
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