NCT01674621

Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 85 Years
• Healthy volunteers: Not accepted

Summary

To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Abaloparatide Transdermal (50 mcg)	Abaloparatide Transdermal Microneedle Active Patch
DRUG	Abaloparatide Transdermal (100 mcg)	Abaloparatide Transdermal Microneedle Active Patch
DRUG	Abaloparatide Transdermal (150 mcg)	Abaloparatide Transdermal Microneedle Active Patch
DRUG	Abaloparatide Injection (80 mcg)	Abaloparatide Subcutaneous Injection
DRUG	Abaloparatide Placebo	Abaloparatide Transdermal Microneedle Placebo Patch

Timeline

• Start date: 2012-09-25
• Primary completion: 2013-08-02
• Completion: 2013-08-02
• First posted: 2012-08-29
• Last updated: 2020-06-16
• Results posted: 2016-12-19

Locations

9 sites across 4 countries: United States, Denmark, Estonia, Poland