A Study for the Transdermal Application of Teriparatide

Status Completed

Clinical Trial Summary

The primary purpose of this study is to help answer the following research questions:

1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).

2. The safety of the teriparatide skin patch and any side effects that might be associated with it.

Clinical Trial Description

Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Osteoporosis

Clinical Trial Details

NCT number	NCT01011556
Study type	Interventional
Source	Eli Lilly and Company
Contact
Status	Completed
Phase	Phase 2
Start date	November 2009
Completion date	September 2011

View Details

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