A New Active Vitamin D, ED-71 for Osteoporosis

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: ED-71; Drug: Alfacalcidol; Drug: Alfacalcidol placebo; Drug: ED-71 placebo

• Registration Number: NCT00144456
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1056

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ED-71	-
1	Alfacalcidol placebo	-
2	ED-71 placebo	-
2	Alfacalcidol	-

Primary Outcome Measures

Name	Time	Method
Incidences of vertebral fracture	throughout study

Secondary Outcome Measures

Name	Time	Method
Changes of Lumbar Spine and total hip bone mineral density	throughout study