MedTrace Logo

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

NCT00165607 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2010-01-29

No results posted yet for this study

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

Interventions

DRUG

MENATETRANONE

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Norio Iinuma · Post-Marketing Clinical Research Department. Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-04-30
Primary Completion
2005-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165607 on ClinicalTrials.gov