NCT04064411

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	abaloparatide	Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
COMBINATION_PRODUCT	abaloparatide solid microstructured transdermal system	Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.

Timeline

• Start date: 2019-08-05
• Primary completion: 2021-10-05
• Completion: 2021-11-09
• First posted: 2019-08-21
• Last updated: 2023-02-15
• Results posted: 2023-02-15

Locations

97 sites across 5 countries: United States, Denmark, Hungary, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study