A New Active Vitamin D, ED-71 for Osteoporosis

August 6, 2013 updated by: Chugai Pharmaceutical

A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1056

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoporotic patients who meet any of the following condition:

    1. with at least one fragility fracture,
    2. above 70 year-old with bone mineral density below 70% young adult mean,
    3. with bone mineral density below 60% young adult mean
  • Women three years or more after menopause or men

Exclusion Criteria:

  • Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis
  • A history or suspicion of active urolithiasis at any time
  • Use of bisphosphonates in the past 12 months
  • Use of medications known to affect bone in the past 2 months
  • Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ED-71
0.75μg/day(p.o.)for 144 weeks
Drug: Alfacalcidol placebo
0 μg/day(p.o.)for 144 weeks
Active Comparator: 2
Drug: Alfacalcidol
1.0μg/day(p.o.)for 144 weeks
Drug: ED-71 placebo
0 μg/day(p.o.)for 144 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of vertebral fracture
Time Frame: throughout study
throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of Lumbar Spine and total hip bone mineral density
Time Frame: throughout study
throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-209JP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe