CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
abaloparatide +1 morecombination
Likely dose
Not stated in 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/NCT04064411
NCT04064411Phase 3Completed
CompareCT.gov

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)

Radius Health, Inc.·interventional·Posted Aug 21, 2019·Updated Feb 15, 2023

In Brief

A Phase 3 clinical trial evaluating abaloparatide and abaloparatide solid microstructured transdermal system for Postmenopausal Osteoporosis. Completed, enrolled 511 participants across 97 sites in 5 countries.

Detailed Summary

A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesDenmark, Hungary, Poland, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 21, 2019
Enrollment StartAug 5, 2019
Primary CompletionOct 5, 2021
Study CompletionNov 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.9 years ago

Interventions

abaloparatidecombination

Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.

abaloparatide solid microstructured transdermal systemcombination

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