Vitamin K in Osteoporosis

Phase 1

• Conditions: Post-menopausal osteoporosis; MedDRA version: 20.1Level: LLTClassification code 10031286Term: Osteoporosis senileSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 20.0Level: LLTClassification code 10031283Term: Osteoporosis fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.0Level: LLTClassification code 10017082Term: Fracture due to osteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2010-022587-12-GB
• Lead Sponsor: Guy's and St. Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-26
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

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

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. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified