The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
teriparatide 20 µg subcutaneous daily
Placebo subcutaneous daily
BA058 20 µg subcutaneous daily
Radius Health, Inc.
Cambridge, Massachusetts, United States
Change in Marker of Bone Metabolism, PINP
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Time frame: 6 months
Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Time frame: 6 months
Change in Bone Mineral Density, Femoral Neck.
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Time frame: 6 months
Change in Bone Mineral Density, Total Hip.
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Time frame: 6 months
Change in Bone Mineral Density, Total Spine.
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Time frame: 12 months
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BA058 40 µg subcutaneous daily
BA058 80 µg subcutaneous daily