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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00577863 (opens ClinicalTrials.gov in a new tab)Other id10586Other idB3D-MC-GHDF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
200 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2008
Primary completion
May 2008
Completion
Dec 2008
First posted
20 Dec 2007 (estimated)
Last update posted
22 Jul 2009 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 3

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

    NCT00577863

    Jan 2008 to Dec 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • teriparatideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Summary of Forteo B Pen Complaints at 8 Weeks

    Time frame · 8 weeks

    Registry description

    Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.

  2. Number of Subjects With Forteo B Pen Complaints at 8 Weeks

    Time frame · 8 weeks

    Registry description

    Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.

  3. Summary of Forteo B Pen Complaints at 46 Weeks

    Time frame · 46 weeks

    Registry description

    Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.

  4. Number of Subjects With Forteo B Pen Complaints at 46 Weeks

    Time frame · 46 weeks

    Registry description

    Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.

Secondary outcomes(20)

  1. Summary of Subject Preference Assessments - Overall Preference

    Time frame · 4 weeks

    Registry description

    To assess overall subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  2. Summary of Subject Preference Assessments - Learning to Use the Pen

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for learning to use the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  3. Summary of Subject Preference Assessments - Attaching a New Needle

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for attaching a new needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  4. Summary of Subject Preference Assessments - Setting the Dose

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for setting the dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  5. Summary of Subject Preference Assessments - Injecting a Dose

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for injecting a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  6. Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for force on the plunger needed to inject a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  7. Summary of Subject Preference Assessments - Assurance That Drug is Delivered

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for assurance that drug is delivered for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  8. Summary of Subject Preference Assessments - Removing a Used Needle

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for removing a used needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  9. Summary of Subject Preference Assessments - Overall Ease of Use

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for overall ease of use for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  10. Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen

    Time frame · 4 weeks

    Registry description

    To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.

  11. Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.

  12. Summary of Subject Perception (Attributes) Assessments - Easy to Read Label

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.

  13. Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.

  14. Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.

  15. Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.

  16. Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.

  17. Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.

  18. Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.

  19. Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.

  20. Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting

    Time frame · 8 weeks

    Registry description

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 8 weeks

Summary of Forteo B Pen Complaints at 8 Weeks

GroupValue (number of complaints)
Forteo B Pen Users47
Primary outcomeNumber· 8 weeks

Number of Subjects With Forteo B Pen Complaints at 8 Weeks

GroupValue (number of participants with complaints)
Forteo B Pen Users31
Secondary and other outcome results(6)
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Overall Preference

GroupValue (participants)
Forteo 1.1 Pen Users2
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Learning to Use the Pen

GroupValue (participants)
Forteo 1.1 Pen Users2
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Attaching a New Needle

GroupValue (participants)
Forteo 1.1 Pen Users2
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Setting the Dose

GroupValue (participants)
Forteo 1.1 Pen Users2
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Injecting a Dose

GroupValue (participants)
Forteo 1.1 Pen Users2
Secondary outcomeNumber· 4 weeks

Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose

GroupValue (participants)
Forteo 1.1 Pen Users2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideTeriparatide 20 micrograms per day–14 / ?134 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2009

Patient experience with a new teriparatide delivery device.

Dore et al. 2009Current medical research and opinioncited by 1

PMID 19656016DOI 10.1185/03007990903173074PUB-19656016

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis in the opinion of the investigator. Subjects must be at high risk for fracture in the opinion of the investigator. 2. Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel. 3. Able to read, understand, and respond to self-administered questionnaires. 4. Without language barrier, cooperative, and expected to return for all follow-up procedures. 5. 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. Exclusion Criteria: 6. Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator. 7. Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator. 8. Subjects who have an increased baseline risk of osteosarcoma, including those with: Paget's disease of the bone or unexplained elevations of alkaline phosphatase, children and young adults with open epiphyses, and subjects who have received external beam or implant radiation therapy involving the skeleton. 9. History of malignant neoplasms in the 5 years prior to study entry, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated, or history of carcinoma in situ of the cervix or uterus.

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