Phase
Condition
Post-menopausal Osteopenia
Post-menopausal Osteoporosis
Osteoporosis
Treatment
placebo
vitamin K1 (phylloquinone)
Clinical Study ID
Ages 18-100 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with eitherpostmenopausal 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 theabove three measurements must be between -1.0 and -2.0
Exclusion
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 duringthe past 3 months;
- Women who have ever been on a bisphosphonate for more than 6 months;
- Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidismor 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 400iu per day);
- Women involved in other clinical trials;
- Any women who, in the opinion of the principal investigator, is at poor medical orpsychiatric risk for the study.
Study Design
Study Description
Connect with a study center
Mt. Sinai Hospital
Toronto, Ontario M5G 1X5
CanadaSite Not Available
St. Michael's Hospital Health Centre
Toronto, Ontario M5C 2T2
CanadaSite Not Available
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario M5S 1B2
CanadaSite Not Available
University Health Network, Osteoporosis Department
Toronto, Ontario M5G 2C4
CanadaSite Not Available
University of Toronto
Toronto, Ontario M5S 3E2
CanadaSite Not Available
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