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A New Active Vitamin D, ED-71 for Osteoporosis

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ClinicalTrials.gov Identifier: NCT00144456
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: ED-71 Drug: Alfacalcidol Drug: ED-71 placebo Drug: Alfacalcidol placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1056 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144456


Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Principal Investigator: Toshio Matsumoto, MD Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144456     History of Changes
Other Study ID Numbers: ED-209JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alfacalcidol
 Hydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances