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A New Active Vitamin D, ED-71 for Osteoporosis - Article


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Osteoporosis

Bone Loss


Clinical Trial: A New Active Vitamin D, ED-71 for Osteoporosis

This study is no longer recruiting patients.

Sponsored by: Chugai Pharmaceutical
Information provided by: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144456

Purpose

A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Condition Intervention Phase
Osteoporosis
 Drug: ED-71
Phase III

MedlinePlus related topics:  Osteoporosis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Prospective, Randomized, Double-Blind Study to Compare the Effect of ED-71 with That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients

Further Study Details: 
Primary Outcomes: Incidences of vertebral fracture
Secondary Outcomes: Changes of Lumbar Spine and total hip bone mineral density
Expected Total Enrollment:  1000

Study start: September 2004

Eligibility

Genders Eligible for Study:  Both
Criteria

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

Location Information

Study chairs or principal investigators

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

More Information

Study ID Numbers:  ED-209JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144456
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13


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July 25, 2008



Page Updated: May 11, 2006
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