Vitamin K and Bone Turnover in Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

Vitamin K and Bone Turnover in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062595
• Other study ID #: DK58363 (completed 2005)
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2003
• Last updated: May 16, 2016
• Start date: September 2000
• Est. completion date: October 2004

Study information

• Verified date: May 2016
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• phylloquinone (K1)

• menatetranone (MK4)

Locations

Country	Name	City	State
United States	University of Wisconsin Osteoporosis Clinical Research Prog.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Eisai Co., Ltd.

Country where clinical trial is conducted

United States, 

External Links

•   UW Osteoporosis Clincal Center and Research Program