Overview

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

Status:
Completed
Trial end date:
2016-10-03
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radius Health, Inc.
Treatments:
Alendronate
Criteria
Inclusion Criteria:

1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or
placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).

2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study
BA058-05-003 (NCT02653417).

Exclusion Criteria:

1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.

2. Participants who experienced a treatment-related serious adverse event (SAE) during
Study BA058-05-003 (NCT02653417).