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

Guy's and St. Thomas' NHS Foundation Trust0 个研究点目标入组 105 人开始时间: 2014年11月26日最近更新: 2020年10月19日

试验速览

暂无简介。

•Inclusion in the cross-sectional part of the study which involves assessment of vitamin K status
•1. Informed consent to pre –screen assessment of vitamin K
•2. ambulatory post-menopausal women aged between 55-85 years
•3. 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)
•4. Treatment with a bisphosphonate and calcium/vitamin D supplements or a bisphosphonate and calcium/vitamin D replete for at least 12 months
•Inclusion into the randomised controlled trial
•1. Informed consent to main study
•2. serum vitamin K concentration = 0.40 µg/L
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 105
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 105

•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. Untreated endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism).
•10. chronic liver disease
•11. current treatment with teriparatide or strontium ranelate
•12. Participation in a trial with an investigational product within the previous 3 months
•13. Serum vitamin K > 0.40 µg/L
•14. current treatment with anti-coagulants such as warfarin

发起方