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A New Active Vitamin D, ED-71 for Osteoporosis

Chugai Pharmaceutical logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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