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Vitamin K and Bone Turnover in Postmenopausal Women



Vitamin K and Bone Turnover in Postmenopausal Women

For Condition: Osteoporosis
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Eisai Medical Research Inc
Synopsis: 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 oral steroids Eligible subjects will take calcuim 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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.
Total Enrollment: 375

Location and Contact Information:

University of Wisconsin Osteoporosis Clinical Research Prog. *Recruiting*
Madison,  Wisconsin,  53705
United States
Recruiting Shari  Zeldin 608-265-6410


Additional Information:
Study ID Numbers:
  VITKBONE; 
Study Start Date: September 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062595

Other Osteoporosis Studies:
1. Hormone Replacement in Young Women with Premature Ovarian Failure

2. CVD Risk and Health in Postmenopausal Phytoestrogen Users

3. Hormone Replacement Therapy to Treat Turner Syndrome

4. Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

5. Osteoporosis Prevention in Preadolescent Girls

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