Status:
UNKNOWN
Vitamin K as Additive Treatment in Osteoporosis
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Post-menopausal Osteoporosis
Eligibility:
FEMALE
55-85 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Vitamin K is important for skeletal health. Vitamin K is essential for the carboxylation of several Gla proteins in bone which are implicated in bone formation and mineralization. These include osteoc...
Eligibility Criteria
Inclusion
- Inclusion in the cross-sectional part of the study which involves assessment of vitamin K status
- Informed consent to screening stage : assessment of vitamin K status
- 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
- Age \<55 years, or \> 85 years
- Male gender
- severe renal impairment (CKD stage 4 and 5)
- poor mobility (inability to walk 100 yards unaided)
- malabsorption (extensive bowel surgery, short bowel)
- generalised carcinomatosis
- glucocorticoid therapy
- inflammatory disorders (e.g. active rheumatoid arthritis, inflammatory bowel disease requiring oral glucocorticoids),
- endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism).
- chronic liver disease
- current treatment with teriparatide, strontium ranelate
- Participation in a trial with an investigational product within the previous 3 months
- Serum vitamin K \> 0.35 µg/ml
- patients on anti-coagulants such as warfarin
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01232647
Start Date
April 1 2015
End Date
March 31 2020
Last Update
February 13 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Guy's and St Thomas' Hospital NHS foundation Trust
London, United Kingdom, SE1 7EH
2
Osteoporosis Unit, Guy's Hospital
London, United Kingdom, SE1 9RT