A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
Once a month, administration of DP-R206 \& placebo for 16 weeks
Once a month, administration of Bonviva \& placebo for 16 weeks
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
A ratio of subject whose 25 OHD concentration is less than 15ng/mL
A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks
Time frame: 16weeks
A ratio of subject whose 25 OHD concentration is less than 9ng/mL
A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks
Time frame: 16 weeks
Safety evaluation (AE, Lab test, Vital sign etc)
Time frame: 16weeks
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