CompletedPhase 3

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

United States, Argentina, Brazil1,139 participantsStarted 2012-11-20

Plain-language 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).

Age range50 Years – 85 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

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 Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.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

Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

NCT IDNCT01657162

SponsorRadius Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10-03

Results submitted2020-09-30