A New Active Vitamin D, ED-71 for Osteoporosis

Sponsor

Chugai Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00144456

Collaborator

(none)

1,056

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: ED-71 Drug: Alfacalcidol Drug: ED-71 placebo Drug: Alfacalcidol placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1056 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Incidences of vertebral fracture [throughout study]

Secondary Outcome Measures

Changes of Lumbar Spine and total hip bone mineral density [throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Locations

No locations specified.

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Principal Investigator: Toshio Matsumoto, MD, Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience