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OpenTrials
Completed

NCT Number: NCT00144456

A New Active Vitamin D, ED-71 for Osteoporosis

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

ED-71

Drug

0.75μg/day(p.o.)for 144 weeks

Alfacalcidol

Drug

1.0μg/day(p.o.)for 144 weeks

ED-71 placebo

Drug

0 μg/day(p.o.)for 144 weeks

Alfacalcidol placebo

Drug

0 μg/day(p.o.)for 144 weeks

Primary outcomes

  1. Incidences of vertebral fracture

    Time frame: throughout study

Secondary outcomes

  1. Changes of Lumbar Spine and total hip bone mineral density

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 5, 2005
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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