NCT00144456

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,056

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

4 years

First QC Date

September 2, 2005

Last Update Submit

August 6, 2013

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Incidences of vertebral fracture

    throughout study

Secondary Outcomes (1)

  • Changes of Lumbar Spine and total hip bone mineral density

    throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: ED-71Drug: Alfacalcidol placebo

2

ACTIVE COMPARATOR
Drug: AlfacalcidolDrug: ED-71 placebo

Interventions

ED-71DRUG

0.75μg/day(p.o.)for 144 weeks

1
AlfacalcidolDRUG

1.0μg/day(p.o.)for 144 weeks

2
ED-71 placeboDRUG

0 μg/day(p.o.)for 144 weeks

2
Alfacalcidol placeboDRUG

0 μg/day(p.o.)for 144 weeks

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoporotic patients who meet any of the following condition:
  • with at least one fragility fracture,
  • above 70 year-old with bone mineral density below 70% young adult mean,
  • with bone mineral density below 60% young adult mean
  • Women three years or more after menopause or men

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22794117DERIVED

  • 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.

    PMID: 21784190DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

eldecalcitolalfacalcidol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Toshio Matsumoto, MD

    Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

August 9, 2013

Record last verified: 2013-08