Trial | NCT00144456  Report issue

Title

A New Active Vitamin D, ED-71 for Osteoporosis
A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1056
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Study Started
Sep 30
2004
Primary Completion
Sep 30
2008
Study Completion
Oct 31
2008
Last Update
Aug 09
2013
Estimate

Drug ED-71

0.75μg/day(p.o.)for 144 weeks

Drug Alfacalcidol

1.0μg/day(p.o.)for 144 weeks

Drug ED-71 placebo

0 μg/day(p.o.)for 144 weeks

Drug Alfacalcidol placebo

0 μg/day(p.o.)for 144 weeks

1 Experimental

2 Active Comparator

Criteria 

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
No Results Posted