CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
Abaloparatide Transdermal (50 mcg) +4 moredrug
Likely dose
Abaloparatide Transdermal (50 mcg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01674621
NCT01674621Phase 2Completed
CompareCT.gov

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

Radius Health, Inc.·interventional·Posted Aug 29, 2012·Updated Jun 16, 2020

In Brief

A Phase 2 clinical trial evaluating Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), and 3 other interventions for Post Menopausal Osteoporosis. Completed, enrolled 250 participants across 9 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Menopausal Osteoporosis
CountriesDenmark, Estonia, Poland, United States
CollaboratorsNordic Bioscience A/S

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2012
Enrollment StartSep 25, 2012
Primary CompletionAug 2, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.8 years ago

Interventions

Abaloparatide Transdermal (50 mcg)drug

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Transdermal (100 mcg)drug

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Transdermal (150 mcg)drug

Abaloparatide Transdermal Microneedle Active Patch

Abaloparatide Injection (80 mcg)drug

Abaloparatide Subcutaneous Injection

Abaloparatide Placebodrug

Abaloparatide Transdermal Microneedle Placebo Patch