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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00577863
First received: December 18, 2007
Last updated: July 13, 2009
Last verified: July 2009
Results First Received: May 5, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Intervention: Drug: teriparatide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Results are reported for participants who received at least one injection of study drug.

Reporting Groups
  Description
Current Users A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
Not Current Users A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.

Participant Flow:   Overall Study
    Current Users     Not Current Users  
STARTED     92     108  
Received at Least One Injection     92     107  
COMPLETED     82     94  
NOT COMPLETED     10     14  
Adverse Event                 4                 2  
Death                 1                 0  
Lost to Follow-up                 2                 2  
Entry Criteria Exclusion                 1                 0  
Withdrawal by Subject                 0                 2  
Sponsor Decision                 2                 7  
Did Not Receive at Least One Injection                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Current Users A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
Not Current Users A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
Total Total of all reporting groups

Baseline Measures
    Current Users     Not Current Users     Total  
Number of Participants  
[units: participants]
  92     107     199  
Age  
[units: years]
Mean ± Standard Deviation
  67.1  ± 11.01     68.5  ± 11.54     67.9  ± 11.30  
Gender  
[units: participants]
     
Female     82     96     178  
Male     10     11     21  
Region of Enrollment  
[units: participants]
     
United States     92     107     199  
Previous Teriparatide Use  
[units: participants]
     
Yes     92     27     119  
No     0     80     80  
Race/Ethnicity  
[units: participants]
     
Caucasian     87     104     191  
African     0     1     1  
Hispanic     2     1     3  
East Asian     3     1     4  
Duration of Prior Forteo 1.1 Pen Experience  
[units: weeks]
Mean ± Standard Deviation
  36.5  ± 23.01     12.9  ± 16.33     31.2  ± 23.78  



  Outcome Measures
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1.  Primary:   Summary of Forteo B Pen Complaints at 8 Weeks   [ Time Frame: 8 weeks ]

2.  Primary:   Number of Subjects With Forteo B Pen Complaints at 8 Weeks   [ Time Frame: 8 weeks ]

3.  Primary:   Summary of Forteo B Pen Complaints at 46 Weeks   [ Time Frame: 46 weeks ]

4.  Primary:   Number of Subjects With Forteo B Pen Complaints at 46 Weeks   [ Time Frame: 46 weeks ]

5.  Secondary:   Summary of Subject Preference Assessments - Overall Preference   [ Time Frame: 4 weeks ]

6.  Secondary:   Summary of Subject Preference Assessments - Learning to Use the Pen   [ Time Frame: 4 weeks ]

7.  Secondary:   Summary of Subject Preference Assessments - Attaching a New Needle   [ Time Frame: 4 weeks ]

8.  Secondary:   Summary of Subject Preference Assessments - Setting the Dose   [ Time Frame: 4 weeks ]

9.  Secondary:   Summary of Subject Preference Assessments - Injecting a Dose   [ Time Frame: 4 weeks ]

10.  Secondary:   Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose   [ Time Frame: 4 weeks ]

11.  Secondary:   Summary of Subject Preference Assessments - Assurance That Drug is Delivered   [ Time Frame: 4 weeks ]

12.  Secondary:   Summary of Subject Preference Assessments - Removing a Used Needle   [ Time Frame: 4 weeks ]

13.  Secondary:   Summary of Subject Preference Assessments - Overall Ease of Use   [ Time Frame: 4 weeks ]

14.  Secondary:   Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen   [ Time Frame: 4 weeks ]

15.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package   [ Time Frame: 8 weeks ]

16.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Read Label   [ Time Frame: 8 weeks ]

17.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen   [ Time Frame: 8 weeks ]

18.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap   [ Time Frame: 8 weeks ]

19.  Secondary:   Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap   [ Time Frame: 8 weeks ]

20.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle   [ Time Frame: 8 weeks ]

21.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle   [ Time Frame: 8 weeks ]

22.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose   [ Time Frame: 8 weeks ]

23.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose   [ Time Frame: 8 weeks ]

24.  Secondary:   Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting   [ Time Frame: 8 weeks ]

25.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use   [ Time Frame: 8 weeks ]

26.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use   [ Time Frame: 8 weeks ]

27.  Secondary:   Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen   [ Time Frame: 8 weeks ]

28.  Secondary:   Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen   [ Time Frame: 8 weeks ]

29.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use   [ Time Frame: 8 weeks ]

30.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections   [ Time Frame: 8 weeks ]

31.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home   [ Time Frame: 8 weeks ]

32.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home   [ Time Frame: 8 weeks ]

33.  Secondary:   Summary of Subject Perception (Attributes) Assessments - Reusing Needles   [ Time Frame: 8 weeks ]

34.  Secondary:   Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle   [ Time Frame: 8 weeks ]

35.  Secondary:   Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle   [ Time Frame: 8 weeks ]

36.  Secondary:   Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00577863     History of Changes
Other Study ID Numbers: 10586, B3D-MC-GHDF
Study First Received: December 18, 2007
Results First Received: May 5, 2009
Last Updated: July 13, 2009
Health Authority: United States: Food and Drug Administration