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CompletedNCT00144456Updated Aug 9, 2013

A New Active Vitamin D, ED-71 for Osteoporosis

A Phase 3 interventional study of ED-71 and Alfacalcidol in Osteoporosis, sponsored by Chugai Pharmaceutical. Completed. Per ClinicalTrials.gov, last updated 2013-08-09.

Sponsored by Chugai Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,056
Allocation
Randomized
Sex
All
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Study summary

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

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 1,056 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,056 participants (actual)

Study arms

  • Experimental
    1

    Drug: ED-71 · Drug: Alfacalcidol placebo

  • Active comparator
    2

    Drug: Alfacalcidol · Drug: ED-71 placebo

Interventions

  • DrugED-71

    0.75μg/day(p.o.)for 144 weeks

  • DrugAlfacalcidol

    1.0μg/day(p.o.)for 144 weeks

  • DrugED-71 placebo

    0 μg/day(p.o.)for 144 weeks

  • DrugAlfacalcidol placebo

    0 μg/day(p.o.)for 144 weeks

06

What researchers measure

Primary outcomes

  1. Incidences of vertebral fracture

    Time frame: throughout study

Secondary outcomes

  1. Changes of Lumbar Spine and total hip bone mineral density

    Time frame: throughout study

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23. PubMed 22794117 ↗
  • Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19. PubMed 21784190 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00144456
Lead sponsor
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Sep 5, 2005
Start date
Sep 2004
Primary completion
Sep 2008
Completion
Oct 2008
Last update
Aug 9, 2013

Study contacts

Toshio Matsumoto, MD
principal investigator · Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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