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The Effect of Vitamin K2 on Bone Turnover

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00548509
First received: October 23, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: Menatetrenone (Vitamin K2)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Menadione
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Gamma-carboxylation

Secondary Outcome Measures:
  • Bone turnover marker

Estimated Enrollment: 100
Study Start Date: February 2002
  Eligibility

Ages Eligible for Study:   49 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548509

Locations
Japan
Kumagaya-shi, Saitama Prefecture, Japan, 350-0831
Hachioji-shi, Tokyo, Japan, 192-0065
Setagaya-Ku, Tokyo, Japan, 157-0066
Nishiyatsushiro-Gun, Yamanashi Prefecture, Japan, 409-3244
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Norio Iinuma Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00548509     History of Changes
Other Study ID Numbers: E0167-J081-191
Study First Received: October 23, 2007
Last Updated: October 23, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin K
Vitamins
Vitamin K 2
Menatetrenone
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013