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The Effect of Vitamin K2 on Bone Turnover

This study has been completed.
Information provided by:
Eisai Inc. Identifier:
First received: October 23, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: None (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:

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

Ages Eligible for Study:   49 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00548509

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
Study Director: Norio Iinuma Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
  More Information Identifier: NCT00548509     History of Changes
Other Study ID Numbers: E0167-J081-191
Study First Received: October 23, 2007
Last Updated: October 23, 2007

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin K
Vitamin K 2
Vitamin MK 7
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on September 20, 2017