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Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)

Phase 3
Not Enrolling
Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia

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Trial Information

Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)

Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women. It
is a systemic disease characterized by low bone mass and deterioration of bone
microarchitecture, resulting in bone fragility and an increased risk of fractures. One in
six women over the age of 50 have osteoporosis. The lifetime risk of an osteoporotic
fracture for an average 50 year-old Canadian woman is >40%. The annual health care costs
for osteoporotic fractures in Canada have been estimated to exceed $1.3 billion.

Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures.
Vitamin K is a co-factor of gamma-glutamyl carboxylase, an enzyme that catalyzes the
gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin.
Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo
studies in animals. Vitamin K levels are low in individuals with osteoporosis and in
patients with osteoporotic fractures. The few studies examining vitamin K supplementation
in humans have showed promising results with no significant side effects, but these studies
had significant methodological shortcomings such as inadequate sample size and lack of

The primary objective of our study is to examine whether vitamin K supplementation will
increase bone mineral density in postmenopausal women with osteopenia. Our secondary
objectives are to examine the possible adverse effects from long-term vitamin K
supplementation, to investigate whether vitamin K will decrease risk of fractures and to
determine if vitamin K affects quality of life. Our hypotheses are that vitamin K increases
bone mineral density in postmenopausal women, and that there are no significant adverse
effects from vitamin K supplementation.

Inclusion Criteria:

Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with
either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2.
Osteopenic: T-score at baseline has to be between (and including) -1.0 and

-2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the
above three measurements must be between -1.0 and -2.0

Exclusion Criteria:

1. Women ever having had a fragility fracture after age 40;

2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months,
or expected to be on anticoagulants in the near future;

3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin
during the past 3 months;

4. Women who have ever been on a bisphosphonate for more than 6 months;

5. Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism
or other metabolic bone diseases;

6. Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart;

7. Women with a history of active cancer in the past 5 years;

8. Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than
400 iu per day);

9. Women involved in other clinical trials;

10. Any women who, in the opinion of the principal investigator, is at poor medical or
psychiatric risk for the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.

Outcome Description:

BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer

Outcome Time Frame:

0 to 24 months

Safety Issue:


Principal Investigator

Angela M Cheung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, University of Toronto


Canada: Health Canada

Study ID:




Start Date:

January 2002

Completion Date:

September 2007

Related Keywords:

  • Post-Menopausal Osteoporosis
  • Post-Menopausal Osteopenia
  • vitamin K
  • bone mineral density
  • post-menopausal women
  • randomized double blind placebo controlled trial
  • osteoporosis
  • women's health
  • Bone Diseases, Metabolic
  • Osteoporosis
  • Osteoporosis, Postmenopausal