NCT04366726

Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

Detailed description

This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	abaloparatide-sMTS	Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.

Timeline

• Start date: 2019-04-09
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2020-04-29
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study