This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
692
Oral
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Time frame: At the final evaluation point
Time-course changes in the percent change of bone metabolism markers
Time frame: Through the treatment period
Time-course changes in the total femoral bone mineral density by the DXA method
Time frame: Through the treatment period
Assessment of adverse events, lab test values
Time frame: Through the treatment period
Frequency of fracture
Time frame: At the final evaluation point
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