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| Sponsor: | University Health Network, Toronto |
|---|---|
| Collaborator: |
Canadian Institutes of Health Research (CIHR) |
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00150969 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Post-Menopausal Osteoporosis Post-Menopausal Osteopenia |
Drug: vitamin K1 (phylloquinone) |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial) |
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | September 2006 |
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 randomization.
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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:
Contacts and Locations| Canada, Ontario | |
| University Health Network, Osteoporosis Department | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| St. Michael's Hospital Health Centre | |
| Toronto, Ontario, Canada, M5C 2T2 | |
| Sunnybrook & Women's College Health Sciences Centre | |
| Toronto, Ontario, Canada, M5S 1B2 | |
| Mt. Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| University of Toronto | |
| Toronto, Ontario, Canada, M5S 3E2 | |
| Principal Investigator: | Angela M Cheung, MD, PhD | University Health Network, University of Toronto |
More Information
| Study ID Numbers: | CIHR-50422 |
| Study First Received: | September 6, 2005 |
| Last Updated: | September 9, 2005 |
| ClinicalTrials.gov Identifier: | NCT00150969 History of Changes |
| Health Authority: | Canada: Health Canada |
|
vitamin K bone mineral density post-menopausal women |
randomized double blind placebo controlled trial osteoporosis women's health |
|
Coagulants Molecular Mechanisms of Pharmacological Action Growth Substances Hematologic Agents Physiological Effects of Drugs Osteoporosis Bone Diseases, Metabolic Bone Diseases Vitamin K 1 Hemostatics |
Pharmacologic Actions Fibrin Modulating Agents Antifibrinolytic Agents Musculoskeletal Diseases Therapeutic Uses Vitamins Osteoporosis, Postmenopausal Vitamin K Micronutrients |