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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)

NCT04366726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-11-22

Study results available
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Summary

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

Conditions

  • Postmenopausal Osteoporosis

Interventions

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.

Sponsors & Collaborators

  • Radius Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Radius Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2019-05-14
Completion
2019-05-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366726 on ClinicalTrials.gov