Back to resultsThe Effect of Vitamin K2 on Bone Turnover
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Menatetrenone (Vitamin K2)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Gamma-carboxylation
Secondary Outcome Measures
Bone turnover marker
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00548509
Brief Title
The Effect of Vitamin K2 on Bone Turnover
Official Title
Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 1, 2002 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Limited
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Menatetrenone (Vitamin K2)
Primary Outcome Measure Information:
Title
Gamma-carboxylation
Secondary Outcome Measure Information:
Title
Bone turnover marker
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norio Iinuma
Organizational Affiliation
Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
Official's Role
Study Director
Facility Information:
City
Kumagaya-shi
State/Province
Saitama Prefecture
ZIP/Postal Code
350-0831
Country
Japan
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0065
Country
Japan
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
City
Nishiyatsushiro-Gun
State/Province
Yamanashi Prefecture
ZIP/Postal Code
409-3244
Country
Japan
12. IPD Sharing Statement
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The Effect of Vitamin K2 on Bone Turnover
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