drugset / Trial / NCT03512262

Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

NCT03512262 ↗

Phase 3 Completed 228 enrolled Radius Health, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.

Timeline

Start
2018-05-03
Primary completion
2021-08-17
Completion
2021-09-08

Outcome

Met primary endpoint

registry analysis (superiority test); Abaloparatide vs Placebo; p <0.0001; Least Squares (LSM) Means Difference 7.3165 (99% CI 5.0668 to 9.5663); NCT03512262 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abaloparatide Peptide 80 ug Subcutaneous

Indications