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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00577863
• Collaborator: (none)
• Enrollment: 200
• Locations: 18
• Duration (Months): 11
• Patients Per Site: 11.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: teriparatide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. Summary of Forteo B Pen Complaints at 8 Weeks [8 weeks]

   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 [8 weeks]

   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 [46 weeks]

   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 [46 weeks]

   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 Outcome Measures

1. Summary of Subject Preference Assessments - Overall Preference [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

   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 [4 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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 [8 weeks]

    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.

21. Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use [8 weeks]

    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 use the Forteo B Pen Instructions for Use.

22. Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.

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

    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 satisfied they were with the Forteo B Pen.

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

    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 confident they were that they received the medication with the Forteo B Pen.

25. Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use [8 weeks]

    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 convenient Forteo B Pen was to use.

26. Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.

27. Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.

28. Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.

29. Summary of Subject Perception (Attributes) Assessments - Reusing Needles [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.

30. Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.

31. Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle [8 weeks]

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.

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

    To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.

2. Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.

3. 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.

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Huntsville	Alabama	United States	35801
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Montgomery	Alabama	United States	36111
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Peoria	Arizona	United States	85381
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Beverly Hills	California	United States	90211
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Laguna Hills	California	United States	92653
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tustin	California	United States	92780
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Trumbull	Connecticut	United States	06611
8	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Palm Harbor	Florida	United States	34684
9	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	S. Miami	Florida	United States	33143
10	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Decatur	Georgia	United States	30033
11	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gainesville	Georgia	United States	30501
12	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wheaton	Maryland	United States	20902
13	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Albany	New York	United States	12206
14	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Asheville	North Carolina	United States	28801
15	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cincinnati	Ohio	United States	45219
16	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Danville	Virginia	United States	24541
17	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tacoma	Washington	United States	98405
18	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Beckley	West Virginia	United States	25801

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Lilly Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00577863
• Other Study ID Numbers: 10586; B3D-MC-GHDF
• First Posted: Dec 20, 2007
• Last Update Posted: Jul 22, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Osteoporosis; Teriparatide

Study Results

Participant Flow

Pre-assignment Detail	Results are reported for participants who received at least one injection of study drug.

Arm/Group Title	Current Users	Not Current Users
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	92	108
Received at Least One Injection	92	107
COMPLETED	82	94
NOT COMPLETED	10	14

Baseline Characteristics

Arm/Group Title	Current Users	Not Current Users	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	92	107	199
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (11.01)	68.5 (11.54)	67.9 (11.30)
Sex: Female, Male (Count of Participants)
Female	82 89.1%	96 89.7%	178 89.4%
Male	10 10.9%	11 10.3%	21 10.6%
Region of Enrollment (participants) [Number]
United States	92 100%	107 100%	199 100%
Previous Teriparatide Use (participants) [Number]
Yes	92 100%	27 25.2%	119 59.8%
No	0 0%	80 74.8%	80 40.2%
Race/Ethnicity (participants) [Number]
Caucasian	87 94.6%	104 97.2%	191 96%
African	0 0%	1 0.9%	1 0.5%
Hispanic	2 2.2%	1 0.9%	3 1.5%
East Asian	3 3.3%	1 0.9%	4 2%
Duration of Prior Forteo 1.1 Pen Experience (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	36.5 (23.01)	12.9 (16.33)	31.2 (23.78)

Outcome Measures

1. Primary Outcome

Title	Summary of Forteo B Pen Complaints at 8 Weeks
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	199
All Complaints	47
Complaint Category: Functional	4
Complaint Category: Nonfunctional	27
Nonfunctional (4%): Pen too large, awkward, bulky	8
Complaint Category: User Manual Related	16
User Manual (3.5%): No information on alcohol swab	7

2. Secondary Outcome

Title	Summary of Subject Preference Assessments - Overall Preference
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	1 1.1%
3 = No Preference	4 4.3%
4	6 6.5%
5 = Strong Preference for Forteo B Pen	79 85.9%

3. Secondary Outcome

Title	Summary of Subject Preference Assessments - Learning to Use the Pen
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	0 0%
3 = No Preference	8 8.7%
4	7 7.6%
5 = Strong Preference for Forteo B Pen	75 81.5%

4. Primary Outcome

Title	Number of Subjects With Forteo B Pen Complaints at 8 Weeks
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
Measure Participants	199
All Complaints	31 33.7%
Complaint Category: Functional	4 4.3%
Complaint Category: Nonfunctional	19 20.7%
Nonfunctional (4%): Pen too large, awkward, bulky	8 8.7%
Complaint Category: User Manual Related	14 15.2%
User Manual (3.5%): No information on alcohol swab	7 7.6%

5. Secondary Outcome

Title	Summary of Subject Preference Assessments - Attaching a New Needle
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	0 0%
3 = No Preference	36 39.1%
4	8 8.7%
5 = Strong Preference for Forteo B Pen	46 50%

6. Secondary Outcome

Title	Summary of Subject Preference Assessments - Setting the Dose
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	0 0%
3 = No Preference	3 3.3%
4	8 8.7%
5 = Strong Preference for Forteo B Pen	79 85.9%

7. Secondary Outcome

Title	Summary of Subject Preference Assessments - Injecting a Dose
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	1 1.1%
3 = No Preference	16 17.4%
4	6 6.5%
5 = Strong Preference for Forteo B Pen	67 72.8%

8. Secondary Outcome

Title	Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	2 2.2%
2	3 3.3%
3 = No Preference	14 15.2%
4	11 12%
5 = Strong Preference for Forteo B Pen	62 67.4%

9. Secondary Outcome

Title	Summary of Subject Preference Assessments - Assurance That Drug is Delivered
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	4 4.3%
2	3 3.3%
3 = No Preference	23 25%
4	16 17.4%
5 = Strong Preference for Forteo B Pen	46 50%

10. Secondary Outcome

Title	Summary of Subject Preference Assessments - Removing a Used Needle
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	3 3.3%
2	1 1.1%
3 = No Preference	36 39.1%
4	7 7.6%
5 = Strong Preference for Forteo B Pen	45 48.9%

11. Secondary Outcome

Title	Summary of Subject Preference Assessments - Overall Ease of Use
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	1 1.1%
2	3 3.3%
3 = No Preference	4 4.3%
4	3 3.3%
5 = Strong Preference for Forteo B Pen	81 88%

12. Secondary Outcome

Title	Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen
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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.

Arm/Group Title	Forteo 1.1 Pen Users
Arm/Group Description	Current users of the Forteo 1.1 Pen.
Measure Participants	92
1 = Strong Preference for Forteo 1.1 Pen	3 3.3%
2	2 2.2%
3 = No Preference	15 16.3%
4	9 9.8%
5 = Strong Preference for Forteo B Pen	63 68.5%

13. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	5 5.4%
4	19 20.7%
5 = Strongly Agree	174 189.1%

14. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Read Label
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	2 2.2%
3	6 6.5%
4	25 27.2%
5 = Strongly Agree	165 179.3%

15. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	1 1.1%
2	1 1.1%
3	0 0%
4	16 17.4%
5 = Strongly Agree	180 195.7%

16. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	1 1.1%
4	15 16.3%
5 = Strongly Agree	182 197.8%

17. Secondary Outcome

Title	Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	0 0%
4	14 15.2%
5 = Strongly Agree	184 200%

18. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	1 1.1%
2	0 0%
3	5 5.4%
4	17 18.5%
5 = Strongly Agree	175 190.2%

19. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	197
1 = Strongly Disagree	0 0%
2	2 2.2%
3	9 9.8%
4	18 19.6%
5 = Strongly Agree	168 182.6%

20. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	197
1 = Strongly Disagree	1 1.1%
2	1 1.1%
3	3 3.3%
4	9 9.8%
5 = Strongly Agree	183 198.9%

21. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	4 4.3%
4	19 20.7%
5 = Strongly Agree	175 190.2%

22. Secondary Outcome

Title	Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting
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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	2 2.2%
3	8 8.7%
4	29 31.5%
5 = Strongly Agree	159 172.8%

23. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use
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 use the Forteo B Pen Instructions for Use.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	8 8.7%
4	16 17.4%
5 = Strongly Agree	174 189.1%

24. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use
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 the overall ease of use.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	0 0%
3	1 1.1%
4	18 19.6%
5 = Strongly Agree	179 194.6%

25. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen
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 satisfied they were with the Forteo B Pen.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Very Dissatisfied	0 0%
2	0 0%
3	4 4.3%
4	18 19.6%
5 = Very Satisfied	176 191.3%

26. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen
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 confident they were that they received the medication with the Forteo B Pen.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	197
1 = Not At All Confident	2 2.2%
2	4 4.3%
3	10 10.9%
4	32 34.8%
5 = Very Confident	149 162%

27. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use
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 convenient Forteo B Pen was to use.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	1 1.1%
3	1 1.1%
4	19 20.7%
5 = Strongly Agree	177 192.4%

28. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections
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 whether the Forteo B Pen reduces their reluctance to take injections.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	197
1 = Strongly Disagree	3 3.3%
2	2 2.2%
3	14 15.2%
4	27 29.3%
5 = Strongly Agree	151 164.1%

29. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home
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 whether the Forteo B Pen helps them manage their osteoporosis when they are at home.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
1 = Strongly Disagree	0 0%
2	1 1.1%
3	3 3.3%
4	15 16.3%
5 = Strongly Agree	179 194.6%

30. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home
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 whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	194
1 = Strongly Disagree	2 2.2%
2	5 5.4%
3	19 20.7%
4	26 28.3%
5 = Strongly Agree	142 154.3%

31. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - Reusing Needles
Description	To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
No	197 214.1%
Yes - Occasionally	0 0%
Yes - Often	0 0%
Yes - Rarely	1 1.1%

32. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle
Description	To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	199
Immediately Before Each Injection	197 214.1%
Several Hours Before Each Use	2 2.2%
At Home If Injection Is Completed Away From Home	5 5.4%
Other	0 0%

33. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle
Description	To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	198
Immediately	197 214.1%
When I Get Home If Injection Completed Away	0 0%
Other	1 1.1%

34. Secondary Outcome

Title	Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use
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 what could be done to improve the Forteo B Pen Instructions for Use.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug and who answered the question.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Measure Participants	199
Larger Print	22 23.9%
More Color	5 5.4%
Less Color	1 1.1%
More Pictures	7 7.6%
Less Pictures	3 3.3%
More Detail in the Description	10 10.9%
Less Detail in the Description	1 1.1%
More Questions and Answers	11 12%
No Improvements Needed	156 169.6%

35. Primary Outcome

Title	Summary of Forteo B Pen Complaints at 46 Weeks
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.
Time Frame	46 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
Measure Participants	199
All Complaints	58
Complaint Category: Functional	9
Functional (3%): Stopped working, wouldn't inject	6
Complaint Category: Nonfunctional	32
Nonfunctional (4%): Pen too large, awkward, bulky	8
Complaint Category: User Manual Related	17
User Manual (3.5%): No information on alcohol swab	7

36. Primary Outcome

Title	Number of Subjects With Forteo B Pen Complaints at 46 Weeks
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.
Time Frame	46 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one injection of study drug.

Arm/Group Title	Forteo B Pen Users
Arm/Group Description	All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
Measure Participants	199
All Complaints	37 40.2%
Complaint Category: Functional	9 9.8%
Functional (3%): Stopped working, wouldn't inject	6 6.5%
Complaint Category: Nonfunctional	21 22.8%
Nonfunctional (4%): Pen too large, awkward, bulky	8 8.7%
Complaint Category: User Manual Related	14 15.2%
User Manual (3.5%): No information on alcohol swab	7 7.6%

Adverse Events

Arm/Group Title	Teriparatide
Arm/Group Description	Teriparatide 20 micrograms per day
All Cause Mortality
	Teriparatide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Teriparatide
	Affected / at Risk (%)	# Events
Total	14/ (NaN)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/199 (0.5%)	1
Cardiac disorders
Arrhythmia	1/199 (0.5%)	1
Atrial fibrillation	1/199 (0.5%)	1
Bradycardia	1/199 (0.5%)	1
Cardiac failure congestive	1/199 (0.5%)	1
Cardiogenic shock/Death	1/199 (0.5%)	1
Gastrointestinal disorders
Diarrhoea	1/199 (0.5%)	1
Intestinal obstruction	1/199 (0.5%)	1
Infections and infestations
Pneumonia	1/199 (0.5%)	1
Injury, poisoning and procedural complications
Ankle fracture	1/199 (0.5%)	1
Cardiac valve replacement complication	1/199 (0.5%)	1
Upper limb fracture	1/199 (0.5%)	1
Metabolism and nutrition disorders
Dehydration	1/199 (0.5%)	1
Fluid overload	1/199 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma	1/199 (0.5%)	1
Breast cancer	1/199 (0.5%)	1
Breast cancer stage II	1/199 (0.5%)	1
Small cell lung cancer stage unspecified	1/199 (0.5%)	1
Nervous system disorders
Syncope	1/199 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/199 (0.5%)	2
Other (Not Including Serious) Adverse Events
	Teriparatide
	Affected / at Risk (%)	# Events
Total	134/ (NaN)
Blood and lymphatic system disorders
Anaemia	4/199 (2%)	4
Ear and labyrinth disorders
Ear pain	2/199 (1%)	2
Vertigo	2/199 (1%)	2
Gastrointestinal disorders
Abdominal pain	2/199 (1%)	2
Gastritis	2/199 (1%)	2
Gastrooesophageal reflux disease	4/199 (2%)	4
Nausea	8/199 (4%)	8
Vomiting	3/199 (1.5%)	3
General disorders
Fatigue	9/199 (4.5%)	9
Injection site bruising	2/199 (1%)	2
Injection site haemorrhage	2/199 (1%)	2
Non-cardiac chest pain	2/199 (1%)	2
Oedema peripheral	4/199 (2%)	4
Immune system disorders
Drug hypersensitivity	2/199 (1%)	2
Infections and infestations
Bronchitis	5/199 (2.5%)	5
Gastroenteritis viral	3/199 (1.5%)	3
Helicobacter infection	2/199 (1%)	2
Influenza	4/199 (2%)	4
Nasopharyngitis	4/199 (2%)	4
Pneumonia	2/199 (1%)	2
Sinusitis	7/199 (3.5%)	7
Upper respiratory tract infection	12/199 (6%)	13
Urinary tract infection	8/199 (4%)	10
Injury, poisoning and procedural complications
Back injury	2/199 (1%)	2
Contusion	8/199 (4%)	9
Excoriation	2/199 (1%)	3
Fall	2/199 (1%)	2
Joint sprain	2/199 (1%)	2
Procedural pain	2/199 (1%)	2
Investigations
Colonoscopy	2/199 (1%)	2
Heart rate irregular	2/199 (1%)	2
Vitamin D decreased	2/199 (1%)	2
Weight decreased	3/199 (1.5%)	3
Metabolism and nutrition disorders
Hypercalcaemia	2/199 (1%)	2
Hypercholesterolaemia	2/199 (1%)	2
Vitamin D deficiency	2/199 (1%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	9/199 (4.5%)	9
Back pain	8/199 (4%)	8
Intervertebral disc degeneration	2/199 (1%)	2
Muscle spasms	3/199 (1.5%)	4
Musculoskeletal pain	7/199 (3.5%)	7
Myalgia	3/199 (1.5%)	4
Osteoarthritis	5/199 (2.5%)	5
Pain in extremity	4/199 (2%)	4
Rotator cuff syndrome	2/199 (1%)	2
Scoliosis	2/199 (1%)	2
Spinal osteoarthritis	3/199 (1.5%)	3
Temporomandibular joint syndrome	2/199 (1%)	2
Nervous system disorders
Dizziness	8/199 (4%)	8
Headache	6/199 (3%)	6
Tremor	2/199 (1%)	2
Psychiatric disorders
Depression	4/199 (2%)	4
Insomnia	2/199 (1%)	2
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	3/199 (1.5%)	3
Dyspnoea	2/199 (1%)	2
Respiratory tract congestion	2/199 (1%)	2
Skin and subcutaneous tissue disorders
Rash	4/199 (2%)	6
Surgical and medical procedures
Dental prosthesis placement	2/199 (1%)	2
Joint arthroplasty	2/199 (1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.