A New Active Vitamin D, ED-71 for Osteoporosis

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Alfacalcidol placebo; Drug: ED-71; Drug: ED-71 placebo; Drug: Alfacalcidol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144456

ED-209JP

Details and patient eligibility

About

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

Enrollment: 1,056 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,056 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: ED-71

Drug: Alfacalcidol placebo

2

Active Comparator group

Treatment:

Drug: Alfacalcidol

Drug: ED-71 placebo