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

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

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).

Key facts

Study ID

NCT01657162

Run by

Radius Health, Inc.

People needed

1139

Starts

2012-11-20

Expected to finish

2016-10-03

Last updated by the study team

2020-12-11

Who can join

Age: 50 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
• The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).

You may not qualify if…

• Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
• Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).

Where it is running

• Study site — Lakewood, Colorado, United States
• Study site — Hialeah, Florida, United States
• Study site — Bethesda, Maryland, United States
• Study site — Buenos Aires, Argentina
• Study site — Brasília, Brazil
• Study site — Curitiba, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — São Paulo, Brazil
• Study site — Vitória, Brazil
• Study site — Brno, Czechia
• Study site — Brno-Vinohrady, Czechia
• Study site — Pardubice, Czechia
• Study site — Aalborg, Denmark
• Study site — Ballerup Municipality, Denmark
• Study site — Vejle, Denmark
• Study site — Tallinn, Estonia
• Study site — Tartu, Estonia
• Study site — Hong Kong, Hong Kong
• Study site — Vilnius, Lithuania
• Study site — Bialystok, Poland
• Study site — Kielce, Poland
• Study site — Lodz, Poland
• Study site — Warsaw, Poland
• Study site — Zgierz, Poland
• Study site — Bucharest, Romania

Full record on ClinicalTrials.gov

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