Clinical Trial: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women

Brief Summary: To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome:

  • Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months [ Time Frame: Baseline and 12 months ]


Original Primary Outcome:

Current Secondary Outcome:

  • Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ]
  • Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months [ Time Frame: Baseline and 12 months ]
  • New Fracture and Fall [ Time Frame: 12 months ]
  • Height (Meter) [ Time Frame: Baseline and 12 months ]


Original Secondary Outcome:

Information By: Eisai Inc.

Dates:
Date Received: September 12, 2005
Date Started: May 2005
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014