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A New Active Vitamin D, ED-71 for Osteoporosis

NCT ID: NCT00144456

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1056 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

ED-71

Intervention Type DRUG

0.75μg/day(p.o.)for 144 weeks

Alfacalcidol placebo

Intervention Type DRUG

0 μg/day(p.o.)for 144 weeks

2

Group Type ACTIVE_COMPARATOR

Alfacalcidol

Intervention Type DRUG

1.0μg/day(p.o.)for 144 weeks

ED-71 placebo

Intervention Type DRUG

0 μg/day(p.o.)for 144 weeks

Interventions

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ED-71

0.75μg/day(p.o.)for 144 weeks

Intervention Type DRUG

Alfacalcidol

1.0μg/day(p.o.)for 144 weeks

Intervention Type DRUG

ED-71 placebo

0 μg/day(p.o.)for 144 weeks

Intervention Type DRUG

Alfacalcidol placebo

0 μg/day(p.o.)for 144 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshio Matsumoto, MD

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type DERIVED
PMID: 22794117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21784190 (View on PubMed)

Other Identifiers

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ED-209JP

Identifier Type: -

Identifier Source: org_study_id