Phase 3 N=440 Randomized Triple-blind Prevention

Vitamin K Supplementation in Post-Menopausal Osteopenia

Post-Menopausal Osteoporosis · Post-Menopausal Osteopenia

Bottom Line

View on ClinicalTrials.gov: NCT00150969 ↗

Enrolled (actual)

440

Serious AEs

9.1%

Results posted

Mar 2012

Primary outcome: Primary: Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms. — -1.28; -1.22 percentage change in BMD — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: vitamin K1 (phylloquinone) (Dietary_supplement); placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University Health Network, Toronto
Primary completion: Sep 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.	-0.40; -1.76	—
PRIMARY Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.	-0.69; -0.88	<0.05 sig
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.	-2.05; -2.71	—
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.	-5.35; -5.23	—
SECONDARY Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker	21; 24	—
SECONDARY Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)	0.58; 0.54	—
SECONDARY Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin	-21.4; -2.0	—
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.	-0.69; -0.88	<0.05 sig
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.	-0.40; -1.76	—
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.	-2.05; -2.71	—
SECONDARY Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.	-5.35; -5.23	—
SECONDARY Difference in Serious Adverse Events	15; 25	—
SECONDARY Difference in Number of New Cancers by Treatment Arm.	3; 12	—
SECONDARY Difference in Number of New Clinical Fractures by Treatment Arm.	11; 21	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00150969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.