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A New Active Vitamin D, ED-71 for Osteoporosis

NCT00144456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2013-08-09

No results posted yet for this study

Summary

A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence

Conditions

Interventions

DRUG

ED-71

0.75μg/day(p.o.)for 144 weeks

DRUG

Alfacalcidol

1.0μg/day(p.o.)for 144 weeks

DRUG

ED-71 placebo

0 μg/day(p.o.)for 144 weeks

DRUG

Alfacalcidol placebo

0 μg/day(p.o.)for 144 weeks

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Toshio Matsumoto, MD · Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-09-30
Completion
2008-10-31

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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 NCT00144456 on ClinicalTrials.gov