A New Active Vitamin D, ED-71 for Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144456
First received: September 2, 2005
Last updated: August 6, 2013
Last verified: August 2013
  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:


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
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 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: August 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 19, 2014