Status:
COMPLETED
Vitamin K Supplementation in Post-Menopausal Osteopenia
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Post-Menopausal Osteoporosis
Post-Menopausal Osteopenia
Eligibility:
FEMALE
18-100 years
Phase:
PHASE3
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00150969
Start Date
January 1 2002
End Date
September 1 2007
Last Update
December 28 2023
Active Locations (5)
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1
St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
2
Mt. Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
3
University Health Network, Osteoporosis Department
Toronto, Ontario, Canada, M5G 2C4
4
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M5S 1B2