Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy

What Was Tested

In this phase 3 trial, researchers set out to test Teriparatide.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 200 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel. Able to read, understand, and respond to self-administered questionnaires. Without language barrier, cooperative, and expected to return for all follow-up procedures. Have provided written informed consent to participate in this study, according to local regulations after being informed of the risks, medications, and procedures to be used in the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator; having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-01 with completion listed for 2008-05.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Summary of Forteo B Pen Complaints at 8 Weeks (time frame: 8 weeks). Number of Subjects With Forteo B Pen Complaints at 8 Weeks (time frame: 8 weeks). Summary of Forteo B Pen Complaints at 46 Weeks (time frame: 46 weeks).

It also tracked 32 secondary outcomes, for example Summary of Subject Preference Assessments - Overall Preference, Summary of Subject Preference Assessments - Learning to Use the Pen, Summary of Subject Preference Assessments - Attaching a New Needle, Summary of Subject Preference Assessments - Assurance That Drug is Delivered, Summary of Subject Preference Assessments - Removing a Used Needle and Summary of Subject Preference Assessments - Overall Ease of Use.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Teriparatide in 200 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, all human trials.