The Effect of Vitamin K2 on Bone Turnover

Eisai

Status and phase

Completed

Phase 4

Conditions

Osteoporosis

Treatments

Drug: Menatetrenone (Vitamin K2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00548509

E0167-J081-191

Details and patient eligibility

About

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.

Enrollment

131 patients

Sex

Female

Ages

49 to 90 years old

Volunteers

No Healthy Volunteers

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.