drugset / Trial / NCT00165607

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

NCT00165607

Phase 4 Completed Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
1996-04
Primary completion
2005-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Menatetrenone Unknown

Indications