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Sponsored by: |
Eisai Limited |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00548509 |
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 |
ChemIDplus related topics: | Vitamin K Menaquinone 4 |
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 |
Ages Eligible for Study: | 49 Years to 90 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 |
Eisai Limited |
Study Director: | Norio Iinuma | Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited |
Study ID Numbers: | E0167-J081-191 |
First Received: | October 23, 2007 |
Last Updated: | October 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00548509 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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