CompletedPhase 3

Vitamin K Supplementation in Post-Menopausal Osteopenia

Canada440 participantsStarted 2002-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexFEMALE

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Inclusion criteria

✓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);

What they're measuring

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

Timeframe: 0 to 24 months

Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.

Timeframe: 0 to 24 months

Trial details

NCT IDNCT00150969

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-09

Results submitted2012-01-10

View on ClinicalTrials.gov More Post-Menopausal Osteoporosis trials