NCT01343004

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,463 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo 0 mcg subcutaneous daily
DRUG	BA058 80 mcg	BA058 80 mcg subcutaneous daily
DRUG	teriparatide	teriparatide 20 mcg subcutaneous daily

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-04-27
• Last updated: 2017-03-01
• Results posted: 2017-03-01

Locations

28 sites across 10 countries: United States, Argentina, Brazil, Czechia, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania