The Effect of Vitamin K2 on Bone Turnover - Full Text View

Sponsored by:	Eisai Limited
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00548509

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 IV

MedlinePlus related topics: Osteoporosis

Drug Information available for: Vitamin K Menaquinone 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research 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, Saitama Prefecture

Kumagaya-shi, Saitama Prefecture, Japan, 350-0831
Japan, Tokyo

Hachioji-shi, Tokyo, Japan, 192-0065

Setagaya-Ku, Tokyo, Japan, 157-0066
Japan, Yamanashi Prefecture

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

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

Study placed in the following topic categories:

Menatetrenone
Antiplasmin
Musculoskeletal Diseases
Vitamin K
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Vitamin K 2
Bone Diseases

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Micronutrients
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009