A New Active Vitamin D, ED-71 for Osteoporosis

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144456
• Other study ID #: ED-209JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: August 6, 2013
• Start date: September 2004
• Est. completion date: October 2008

Study information

• Verified date: August 2013
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• ED-71
0.75µg/day(p.o.)for 144 weeks
• Alfacalcidol
1.0µg/day(p.o.)for 144 weeks
• ED-71 placebo
0 µg/day(p.o.)for 144 weeks
• Alfacalcidol placebo
0 µg/day(p.o.)for 144 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of vertebral fracture		throughout study	No
Secondary	Changes of Lumbar Spine and total hip bone mineral density		throughout study	No