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

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

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

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 ]