Vitamin K as Additive Treatment in Osteoporosis

• Status: Active, not recruiting
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: Female

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 want to test the hypothesis that treatment with bisphosphonates combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer additional benefit on skeletal metabolism and reduction of 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Treatments: Menatetrenone; Vitamin K; Vitamin K 1; Vitamin K 2; Vitamins

Criteria

Inclusion Criteria:

Inclusion in the cross-sectional part of the study which involves assessment of vitamin K status

1. Informed consent to screening stage : assessment of vitamin K status

2. serum vitamin K concentration < 0.35 ug/ml

Inclusion into the randomised controlled trial

1. ambulatory post-menopausal women aged between 55-85 years 2. Post-menopausal osteoporosis ( history of previous fragility fractures or BMD evidence of osteoporosis or osteopenia with at least one clinical risk factors such as low BMI, positive family history of osteoporosis) 3. Treatment with a bisphosphonate and calcium/vitamin D supplements for at least 12 months 4. Informed written consent 5. e GFR >30 ml/min 6. normocalcaemia

• Exclusion Criteria:

1. Age <55 years, or > 85 years

2. Male gender

3. severe renal impairment (CKD stage 4 and 5)

4. poor mobility (inability to walk 100 yards unaided)

5. malabsorption (extensive bowel surgery, short bowel)

6. generalised carcinomatosis

7. glucocorticoid therapy

8. inflammatory disorders (e.g. active rheumatoid arthritis, inflammatory bowel disease requiring oral glucocorticoids),

9. endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism).

10. chronic liver disease

11. current treatment with teriparatide, strontium ranelate

12. Participation in a trial with an investigational product within the previous 3 months

13. Serum vitamin K > 0.35 µg/ml

14. patients on anti-coagulants such as warfarin