Text Size

A New Active Vitamin D, ED-71 for Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144456
First received: September 2, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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
Drug: Alfacalcidol
Drug: ED-71 placebo
Drug: Alfacalcidol placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Incidences of vertebral fracture [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of Lumbar Spine and total hip bone mineral density [ Time Frame: throughout study ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Chugai Pharmaceutical

Additional 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
Study First Received: September 2, 2005
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hydroxycholecalciferols
1-hydroxycholecalciferol
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013