This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The Catholic University of Korea Yeouido Saint Mary's Hospital
Seoul, South Korea
Bone mineral density (BMD) change rate
The % change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Time frame: 12 month
Bone mineral density (BMD) change
The change from baseline in lumbar spine Bone mineral density (BMD) through end of 12-month treatment.
Time frame: 12 month
Bone mineral density (BMD) change
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Time frame: 6 and 18 month
Bone mineral density (BMD) % change
The change \& % change from baseline in lumbar spine Bone mineral density (BMD) through end of 6 and 18-month treatment.
Time frame: 6 and 18 month
Bone mineral density (BMD) change
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Time frame: 6, 12 and 18 month
Bone mineral density (BMD) % change
The change \& % change from baseline in total hip Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Time frame: 6, 12 and 18 month
Bone mineral density (BMD) change
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Time frame: 6, 12 and 18 month
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Bone mineral density (BMD) % change
The change \& % change from baseline in femoral neck Bone mineral density (BMD) through end of 6, 12 and 18-month treatment.
Time frame: 6, 12 and 18 month
% incidence of new non-vertebral fractures
The % incidence of new non-vertebral fractures over 12 months of treatment
Time frame: 12 month