The Effect of Vitamin K2 on Bone Turnover
Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study
1 other identifier
interventional
131
1 country
4
Brief Summary
To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2002
Longer than P75 for phase_4
4 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
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 23, 2007
CompletedFirst Posted
Study publicly available on registry
October 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 29, 2018
October 1, 2007
10.9 years
October 23, 2007
October 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Gamma-carboxylation
Secondary Outcomes (1)
Bone turnover marker
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.
- These criteria state that patients with a lumbar bone mineral density (BMD)\<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD\<80% of the young adult mean can be diagnosed as having osteoporosis.
You may not qualify if:
- Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ).
- Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Limitedlead
Study Sites (4)
Unknown Facility
Kumagaya-shi, Saitama, 350-0831, Japan
Unknown Facility
Hachioji-shi, Tokyo, 192-0065, Japan
Unknown Facility
Setagaya-Ku, Tokyo, 157-0066, Japan
Unknown Facility
Nishiyatsushiro-Gun, Yamanashi, 409-3244, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Norio Iinuma
Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2007
First Posted
October 24, 2007
Study Start
February 1, 2002
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
October 29, 2018
Record last verified: 2007-10