Trials / Completed

CompletedNCT00165607

Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)

Status: Completed
Phase: Phase 4
Study type: Interventional
Enrollment: —

Sponsor: Eisai Limited · Industry
Sex: Female
Age: 50 Years
Healthy volunteers: Not accepted

Summary

To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.

Conditions

Osteoporosis

Interventions

Type	Name	Description
DRUG	MENATETRANONE

Timeline

Start date: 1996-04-01
Primary completion: 2005-06-01
First posted: 2005-09-14
Last updated: 2010-01-29

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00165607. Inclusion in this directory is not an endorsement.