CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
vitamin K1 (phylloquinone) +1 moredietary
Likely dose
Vitamin K1 (phylloquinone) 1 pill dailyAI-extracted
Key inclusion· 2
  • ✓Postmenopausal status: ≥1 year since natural cessation of menses, OR hysterectomy with FSH confirmation of postmenopausal status, OR age ≥55
  • ✓Osteopenia: T-score between -1.0 and -2.0 (inclusive) at lumbar spine (L1-L4), total hip, or femoral neck, with lowest of three measurements in this range
Key exclusion· 9
  • ✕History of fragility fracture after age 40
  • ✕Current or recent anticoagulant use (within past 3 months) or planned future use
  • ✕Bone-active therapy in past 3 months: hormone replacement therapy, raloxifene, bisphosphonates, or calcitonin
  • ✕Prior bisphosphonate use for >6 months duration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00150969
NCT00150969Phase 3Completed
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Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)

University Health Network, Toronto·interventional·Posted Sep 8, 2005·Updated Dec 28, 2023

In Brief

A Phase 3 clinical trial evaluating vitamin K1 (phylloquinone) and placebo for Post-Menopausal Osteoporosis and Post-Menopausal Osteopenia. Completed, enrolled 440 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Menopausal Osteoporosis, Post-Menopausal Osteopenia
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR)

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 1, 2002
Primary CompletionSep 1, 2006
Study CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 years ago

Interventions

vitamin K1 (phylloquinone)dietary

placebodietary

1 pill daily