Completed
PHASE3
INTERVENTIONAL
NCT04064411
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
Detailed Description
This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 micrograms (mcg) compared to abaloparatide-SC 80 mcg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis.
Interventions
Name:
abaloparatide
Type:
COMBINATION_PRODUCT
Description:
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Name:
abaloparatide solid microstructured transdermal system
Type:
COMBINATION_PRODUCT
Description:
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Primary Outcomes
Measure:
Percent Change From Baseline in Lumbar Spine BMD at Month 12
TimeFrame:
Baseline, Month 12
Description:
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Trial Information
NCT ID
NCT04064411
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Radius Health, Inc.
Last Updated
December 15, 2025