Vitamin K Supplementation in Post-Menopausal Osteopenia
Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
About this trial
This is an interventional prevention trial for Post-Menopausal Osteoporosis focused on measuring vitamin K, bone mineral density, post-menopausal women, randomized double blind placebo controlled trial, osteoporosis, women's health
Eligibility Criteria
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: Women ever having had a fragility fracture after age 40; Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future; Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months; Women who have ever been on a bisphosphonate for more than 6 months; Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases; Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart; Women with a history of active cancer in the past 5 years; Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day); Women involved in other clinical trials; Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Sites / Locations
- St. Michael's Hospital Health Centre
- Mt. Sinai Hospital
- University Health Network, Osteoporosis Department
- Sunnybrook & Women's College Health Sciences Centre
- University of Toronto
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
phyloquinone
placebo
5 mg Vitamin K1