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A New Active Vitamin D, ED-71 for Osteoporosis

This study has been completed.
Information provided by (Responsible Party):
Chugai Pharmaceutical Identifier:
First received: September 2, 2005
Last updated: August 6, 2013
Last verified: August 2013
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 Drug: Alfacalcidol Drug: ED-71 placebo Drug: Alfacalcidol placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Incidences of vertebral fracture [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Changes of Lumbar Spine and total hip bone mineral density [ Time Frame: throughout study ]

Enrollment: 1056
Study Start Date: September 2004
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00144456

Sponsors and Collaborators
Chugai Pharmaceutical
Principal Investigator: Toshio Matsumoto, MD Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chugai Pharmaceutical Identifier: NCT00144456     History of Changes
Other Study ID Numbers: ED-209JP
Study First Received: September 2, 2005
Last Updated: August 6, 2013

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances processed this record on August 18, 2017