Conditions: Osteoporosis Postmenopausal Osteoporosis
Keywords: BA058 abaloparatide Abaloparatide-SC osteoporosis postmenopausal bone loss ACTIVE fracture
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2463
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Placebo identical in appearance to BA058 study drug arm 2: None arm 3: Blinded until after randomization, then open-label

Interventions: intervention 1: Placebo intervention 2: BA058 80 mcg intervention 3: teriparatide
Intervention descriptions: intervention 1: Placebo 0 mcg subcutaneous daily intervention 2: BA058 80 mcg subcutaneous daily intervention 3: teriparatide 20 mcg subcutaneous daily

Protocol document: