Status:
COMPLETED
A New Active Vitamin D, ED-71 for Osteoporosis
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Osteoporosis
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
1056 Patients enrolled
Trial Details
Trial ID
NCT00144456
Start Date
September 1 2004
End Date
October 1 2008
Last Update
August 9 2013
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