A New Active Vitamin D, ED-71 for Osteoporosis - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144456

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 III

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Vitamin D Ergocalciferol Alfacalcidol ED 71

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ED-71 0.75μg/day(p.o.)for 144 weeks Drug: Alfacalcidol placebo 0 μg/day(p.o.)for 144 weeks
2: Active Comparator	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

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

Responsible Party:	- ( Chugai Pharmaceutical )
Study ID Numbers:	ED-209JP
Study First Received:	September 2, 2005
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00144456
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Vitamin D
Musculoskeletal Diseases
1-hydroxycholecalciferol
Fractures, Bone
Ergocalciferols

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Hydroxycholecalciferols

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009