- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548509
The Effect of Vitamin K2 on Bone Turnover
October 26, 2018 updated by: Eisai Limited
Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saitama Prefecture
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Kumagaya-shi, Saitama Prefecture, Japan, 350-0831
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Tokyo
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Hachioji-shi, Tokyo, Japan, 192-0065
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Setagaya-Ku, Tokyo, Japan, 157-0066
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Yamanashi Prefecture
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Nishiyatsushiro-Gun, Yamanashi Prefecture, Japan, 409-3244
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
49 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Gamma-carboxylation
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Secondary Outcome Measures
Outcome Measure |
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Bone turnover marker
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Norio Iinuma, Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2002
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 23, 2007
First Submitted That Met QC Criteria
October 23, 2007
First Posted (Estimate)
October 24, 2007
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Micronutrients
- Vitamins
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Vitamin K 2
- Menatetrenone
Other Study ID Numbers
- E0167-J081-191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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