A New Active Vitamin D, ED-71 for Osteoporosis

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Alfacalcidol; Eldecalcitol; Hydroxycholecalciferols

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