Osteoporosis
Conditions
Brief summary
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Interventions
DRUGED-71
0.75μg/day(p.o.)for 144 weeks
DRUGAlfacalcidol
1.0μg/day(p.o.)for 144 weeks
DRUGED-71 placebo
0 μg/day(p.o.)for 144 weeks
DRUGAlfacalcidol placebo
0 μg/day(p.o.)for 144 weeks
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of vertebral fracture | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Lumbar Spine and total hip bone mineral density | throughout study |
Outcome results
None listed