Osteoporosis |
Bone Loss |
Clinical Trial: A New Active Vitamin D, ED-71 for Osteoporosis
This study is no longer recruiting patients.
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Osteoporosis | Drug: ED-71 | Phase III |
MedlinePlus related topics: Osteoporosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Double-Blind Study to Compare the Effect of ED-71 with That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients
Secondary Outcomes: Changes of Lumbar Spine and total hip bone mineral density
Expected Total Enrollment: 1000
Study start: September 2004
Eligibility
Inclusion Criteria:
-
Osteoporotic patients who meet any of the following condition:
- 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
Location Information
Toshio Matsumoto, MD, Principal Investigator, Department of Medicine and Bioregulatory Sciences, Universitof Tokushima Graduate School of Health Bioscience
More Information
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144456
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13

Not Signed In -


