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Vitamin K Supplementation in Post-menopausal Osteoporosis
NCT01232647Phase 3
Key facts
- Status
- Unknown
- Start
- Apr 2015
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- osteoporosis
01
Overview
Phase 3, randomised, double-blind trial in osteoporosis comparing Vitamin K1, Menatetrenone MK4 and Placebo (3 arms). Primary endpoint: Bone Mineral Density at 18 months. Status: unknown.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Vitamin K1
Phylloquinone 1.0 mg daily
Menatetrenone MK4
Menatetrenone 45 mg daily
Placebo
Placebo pills
03
Who it enrols
Post-menopausal women aged 55-85 with osteoporosis and low vitamin K status (<0.35 ug/ml) who have been on bisphosphonate and calcium/vitamin D treatment for at least 12 months.
04
Endpoints
Primary
Bone Mineral Density
Secondary
Biochemical Markers of Bone Turnover
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