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Post-menopausal Osteoporosis | Vitamin K as Additive Treatment in Osteoporosis

Post-menopausal Osteoporosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post-menopausal Osteoporosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Phylloquinone1.0 mg daily of vitamin K1

Drug:Menatetrenone (MK4)Menatetrenone (MK4) 45 mg daily

Drug:placeboplacebo vitamin K1 and placebo MK4 given daily for 18 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vitamin k11.0 mg of vitamin K1 (phylloquinone) and placebo MK4 will be given to one of the treatment arm for 18 months

placebo vitamin K1 and MK4placebo pill of both vitamin K1 and MK4 given for 18 months to the control arm

Menatetrenone MK445 mg MK4 given daily and placebo vitamin K1 will be given to one of treatment arm for 18 months

Study Status

Recruiting

Start Date: April 2015

Completed Date: March 2020

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Primary outcome measures- Changes in BMD at the Lumber spine, hip, fore-arm at 18 months.

Secondary Outcome: Secondary outcome measure- Bone Turnover as assessed by the biochemical markers (serum CTX, P1NP, BALP, carboxylated and undercarboxylated osteocalcin (OC), OPG). These markers will be measured at the same time point during each clinic visit.

Study sponsors, principal investigator, and references

Principal Investigator: Geeta Hampson, MD

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01232647

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