Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062595
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2003-06-09
Brief Title:
Vitamin K and Bone Turnover in Postmenopausal Women
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Vitamin K and Bone Turnover in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None