CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
teriparatidedrug
Likely dose
teriparatide 20 microgramsfrom 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/NCT00577863
NCT00577863Phase 3Completed

B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy

Eli Lilly and Company·interventional·Posted Dec 20, 2007·Updated Jul 22, 2009

In Brief

A Phase 3 clinical trial evaluating teriparatide for Osteoporosis. Completed, enrolled 200 participants across 18 sites.

Detailed Summary

This study is being conducted to collect information from subjects with osteoporosis regarding their experience using the Forteo B Pen to self-administer teriparatide in the community setting. Information collected during this study will be used to assess the need for changes to the Forteo B-Pen User Manual and patient educational tools. Additionally, the information generated from patients during this trial will be reviewed to assess the acceptability of the Forteo B Pen for commercial launch.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2007
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.5 years ago

Interventions

teriparatidedrug

Subcutaneous injection of teriparatide 20 micrograms once daily using the Forteo B Pen. The primary phase of the study is 8 weeks after which time patients may participate in a study extension until the patient completes their maximum duration of teriparatide therapy or the Forteo B Pen becomes commercially available.