DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Vitamin K and Bone Turnover in Postmenopausal Women

Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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
Last updated: March 17, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017