Vitamin K in osteoporosis

• Research type

  Research Study

• Full title

  The Additive effect of Vitamin K Supplementation and Bisphosphonate on Fracture Risk in Post-menopausal Osteoporosis

• IRAS ID

  59675

• Contact name

  Geeta Hampson

• Sponsor organisation

  Guy's & St Thomas' Foundation NHS Trust, R&D Department

• Eudract number

  2010-022587-12

• ISRCTN Number

  xx

• Research summary

  Research Summary:
  Vitamin K is thought to be important for bone health because it activates several proteins involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main dietary form of vitamin K (called K1) or another common form which our bodies make from K1(called MK4), to improve bone health have given mixed results. This confusion is thought to have arisen because these studies involved people who already had enough vitamin K or did not have osteoporosis. We think the benefits of giving vitamin K may be greatest in patients with a poor vitamin K status (identified using laboratory tests) and osteoporosis. Giving extra vitamin K to this population to correct their body stores, in addition to their regular treatment for post-menopausal osteoporosis, may further improve bone density and fracture risk. We want to test this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with low vitamin K will then be recruited to study the effect of supplementation with either K1 or MK4.

  Summary of results:
  Several studies have highlighted the importance of vitamin K (best known for its effects on blood clotting) for bone health. The two main forms of vitamin K are vitamin K1 (the main dietary form) and vitamin K2 (called MK-4) which our bodies make from K1. We carried out a trial to see if using vitamin K1 or MK-4 together with an oral bisphosphonate for women with post-menopausal osteoporosis (PMO) could further strengthen bone. We studied 105 women with PMO and low vitamin K1 (<0.4 ug/L) who were randomised to three groups and received placebo or vitamin K1 (1.0 mg/day) or MK-4 (45 mg/day) for 18 months. Our results showed that changes in bone mineral density at the hip and lumbar spine, and the bone turnover markers measured from the blood samples did not differ significantly following either K1 or MK-4 supplementation compared to placebo. However, our results did show that the use of vitamin K1 may have a positive effect on parameters of hip geometry, and this could improve hip bone mechanical strength.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/72

• Date of REC Opinion

  9 Nov 2010

• REC opinion

  Further Information Favourable Opinion