The Effect of Vitamin K2 on Bone Turnover

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548509
• Other study ID #: E0167-J081-191
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2002
• Est. completion date: January 2013

Study information

• Verified date: October 2007
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 49 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Menatetrenone (Vitamin K2)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gamma-carboxylation
Secondary	Bone turnover marker