Vitamin K as Additive Treatment in Osteoporosis
VITKANDOP
The Additive Effect of Vitamin K Supplementation and Bisphosphonate on Fracture Risk in Post-menopausal Osteoporosis
1 other identifier
interventional
105
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2015
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedFebruary 13, 2020
February 1, 2020
5 years
November 1, 2010
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome measures- Changes in BMD at the Lumber spine, hip, fore-arm at 18 months.
Measurement of changes in bone mineral density by DXA scan.
18 months
Secondary Outcomes (1)
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.
18 months
Study Arms (3)
Vitamin k1
ACTIVE COMPARATOR1.0 mg of vitamin K1 (phylloquinone) and placebo MK4 will be given to one of the treatment arm for 18 months
placebo vitamin K1 and MK4
PLACEBO COMPARATORplacebo pill of both vitamin K1 and MK4 given for 18 months to the control arm
Menatetrenone MK4
ACTIVE COMPARATOR45 mg MK4 given daily and placebo vitamin K1 will be given to one of treatment arm for 18 months
Interventions
placebo vitamin K1 and placebo MK4 given daily for 18 months
Eligibility Criteria
You may qualify if:
- Informed consent to screening stage : assessment of vitamin K status
- serum vitamin K concentration \< 0.35 ug/ml
- \. 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guy's and St Thomas' Hospital NHS foundation Trust
London, SE1 7EH, United Kingdom
Osteoporosis Unit, Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Moore AE, Dulnoan D, Voong K, Ayis S, Mangelis A, Gorska R, Harrington DJ, Tang JCY, Fraser WD, Hampson G. The additive effect of vitamin K supplementation and bisphosphonate on fracture risk in post-menopausal osteoporosis: a randomised placebo controlled trial. Arch Osteoporos. 2023 Jun 20;18(1):83. doi: 10.1007/s11657-023-01288-w.
PMID: 37338608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Geeta Hampson, MD
Guy's and St Thomas' NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 2, 2010
Study Start
April 1, 2015
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
February 13, 2020
Record last verified: 2020-02