The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Unnamed facility
Chubu Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Pain (Subjective Symptom)
Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable".
Time frame: Baseline and Week 4
Improvement Rate of Pain (Doctor's Judgment)
Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by "stopped or almost stopped" or "alleviated".
Time frame: Baseline and Week 4
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