The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,463
Placebo 0 mcg subcutaneous daily
BA058 80 mcg subcutaneous daily
teriparatide 20 mcg subcutaneous daily
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Miami, Florida, United States
Number of Participants With New Vertebral Fractures at 18 Months
Time frame: 18 months
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months
Time frame: Basline and 18 months
Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18
Time frame: Baseline and 18 months
Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18
Time frame: Baseline and 18 months
Number of Participants With Non-vertebral Fractures at 18 Months
Time frame: 18 months
Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months
Time frame: 18 months
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Unnamed facility
North Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Buenos Aires, Argentina
Unnamed facility
Brasília, Brazil
Unnamed facility
Curitiba, Brazil
Unnamed facility
Rio de Janeiro, Brazil
Unnamed facility
São Paulo, Brazil
...and 18 more locations