Vitamin K and Bone Turnover in Postmenopausal Women

Vitamin K and Bone Turnover in Postmenopausal Women

Sponsoren

Hauptsponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Mitarbeiter: Eisai Co., Ltd.

Quelle National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum September 2000
Fertigstellungstermin October 2004
Phase Phase 3
Studientyp Interventional
Einschreibung 375
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: phylloquinone (K1)

Interventionsart: Drug

Interventionsname: menatetranone (MK4)

Teilnahmeberechtigung

Kriterien:

- 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.

Geschlecht: Female

Mindestalter: N/A

Maximales Alter: N/A

Gesunde Freiwillige: Accepts Healthy Volunteers

Ort
Einrichtung: University of Wisconsin Osteoporosis Clinical Research Prog.
Standort Länder

United States

Überprüfungsdatum

May 2016

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov