Trial Outcomes & Findings for Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy (NCT NCT00577863)

NCT ID: NCT00577863

Last Updated: 2009-07-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 200 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2009-07-22

Participant Flow

Results are reported for participants who received at least one injection of study drug.

Participant milestones

Measure	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.
Overall Study STARTED	92	108
Overall Study Received at Least One Injection	92	107
Overall Study COMPLETED	82	94
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	4	2
Overall Study Death	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Entry Criteria Exclusion	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Sponsor Decision	2	7
Overall Study Did Not Receive at Least One Injection	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Current Users n=92 Participants 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 n=107 Participants 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 n=199 Participants Total of all reporting groups
Age Continuous	67.1 years STANDARD_DEVIATION 11.01 • n=5 Participants	68.5 years STANDARD_DEVIATION 11.54 • n=7 Participants	67.9 years STANDARD_DEVIATION 11.30 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	96 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	107 participants n=7 Participants	199 participants n=5 Participants
Previous Teriparatide Use Yes	92 participants n=5 Participants	27 participants n=7 Participants	119 participants n=5 Participants
Previous Teriparatide Use No	0 participants n=5 Participants	80 participants n=7 Participants	80 participants n=5 Participants
Race/Ethnicity Caucasian	87 participants n=5 Participants	104 participants n=7 Participants	191 participants n=5 Participants
Race/Ethnicity African	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity Hispanic	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity East Asian	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Duration of Prior Forteo 1.1 Pen Experience	36.5 weeks STANDARD_DEVIATION 23.01 • n=5 Participants	12.9 weeks STANDARD_DEVIATION 16.33 • n=7 Participants	31.2 weeks STANDARD_DEVIATION 23.78 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=199 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Forteo B Pen Complaints at 8 Weeks All Complaints	47 number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks Complaint Category: Functional	4 number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks Complaint Category: Nonfunctional	27 number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks Nonfunctional (4%): Pen too large, awkward, bulky	8 number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks Complaint Category: User Manual Related	16 number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks User Manual (3.5%): No information on alcohol swab	7 number of complaints

PRIMARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=199 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Number of Subjects With Forteo B Pen Complaints at 8 Weeks All Complaints	31 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 8 Weeks Complaint Category: Functional	4 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 8 Weeks Complaint Category: Nonfunctional	19 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 8 Weeks Nonfunctional (4%): Pen too large, awkward, bulky	8 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 8 Weeks Complaint Category: User Manual Related	14 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 8 Weeks User Manual (3.5%): No information on alcohol swab	7 number of participants with complaints

PRIMARY outcome

Timeframe: 46 weeks

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

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.

Outcome measures

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

PRIMARY outcome

Timeframe: 46 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=199 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Number of Subjects With Forteo B Pen Complaints at 46 Weeks All Complaints	37 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks Complaint Category: Functional	9 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks Functional (3%): Stopped working, wouldn't inject	6 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks Complaint Category: Nonfunctional	21 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks Nonfunctional (4%): Pen too large, awkward, bulky	8 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks Complaint Category: User Manual Related	14 number of participants with complaints
Number of Subjects With Forteo B Pen Complaints at 46 Weeks User Manual (3.5%): No information on alcohol swab	7 number of participants with complaints

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Overall Preference 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Overall Preference 2	1 participants
Summary of Subject Preference Assessments - Overall Preference 3 = No Preference	4 participants
Summary of Subject Preference Assessments - Overall Preference 4	6 participants
Summary of Subject Preference Assessments - Overall Preference 5 = Strong Preference for Forteo B Pen	79 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Learning to Use the Pen 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Learning to Use the Pen 2	0 participants
Summary of Subject Preference Assessments - Learning to Use the Pen 3 = No Preference	8 participants
Summary of Subject Preference Assessments - Learning to Use the Pen 4	7 participants
Summary of Subject Preference Assessments - Learning to Use the Pen 5 = Strong Preference for Forteo B Pen	75 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Attaching a New Needle 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Attaching a New Needle 2	0 participants
Summary of Subject Preference Assessments - Attaching a New Needle 3 = No Preference	36 participants
Summary of Subject Preference Assessments - Attaching a New Needle 4	8 participants
Summary of Subject Preference Assessments - Attaching a New Needle 5 = Strong Preference for Forteo B Pen	46 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Setting the Dose 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Setting the Dose 2	0 participants
Summary of Subject Preference Assessments - Setting the Dose 3 = No Preference	3 participants
Summary of Subject Preference Assessments - Setting the Dose 4	8 participants
Summary of Subject Preference Assessments - Setting the Dose 5 = Strong Preference for Forteo B Pen	79 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Injecting a Dose 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Injecting a Dose 2	1 participants
Summary of Subject Preference Assessments - Injecting a Dose 3 = No Preference	16 participants
Summary of Subject Preference Assessments - Injecting a Dose 4	6 participants
Summary of Subject Preference Assessments - Injecting a Dose 5 = Strong Preference for Forteo B Pen	67 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose 1 = Strong Preference for Forteo 1.1 Pen	2 participants
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose 2	3 participants
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose 3 = No Preference	14 participants
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose 4	11 participants
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose 5 = Strong Preference for Forteo B Pen	62 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Assurance That Drug is Delivered 1 = Strong Preference for Forteo 1.1 Pen	4 participants
Summary of Subject Preference Assessments - Assurance That Drug is Delivered 2	3 participants
Summary of Subject Preference Assessments - Assurance That Drug is Delivered 3 = No Preference	23 participants
Summary of Subject Preference Assessments - Assurance That Drug is Delivered 4	16 participants
Summary of Subject Preference Assessments - Assurance That Drug is Delivered 5 = Strong Preference for Forteo B Pen	46 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Removing a Used Needle 1 = Strong Preference for Forteo 1.1 Pen	3 participants
Summary of Subject Preference Assessments - Removing a Used Needle 2	1 participants
Summary of Subject Preference Assessments - Removing a Used Needle 3 = No Preference	36 participants
Summary of Subject Preference Assessments - Removing a Used Needle 4	7 participants
Summary of Subject Preference Assessments - Removing a Used Needle 5 = Strong Preference for Forteo B Pen	45 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Overall Ease of Use 1 = Strong Preference for Forteo 1.1 Pen	1 participants
Summary of Subject Preference Assessments - Overall Ease of Use 2	3 participants
Summary of Subject Preference Assessments - Overall Ease of Use 3 = No Preference	4 participants
Summary of Subject Preference Assessments - Overall Ease of Use 4	3 participants
Summary of Subject Preference Assessments - Overall Ease of Use 5 = Strong Preference for Forteo B Pen	81 participants

SECONDARY outcome

Timeframe: 4 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=92 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen 1 = Strong Preference for Forteo 1.1 Pen	3 participants
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen 2	2 participants
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen 3 = No Preference	15 participants
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen 4	9 participants
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen 5 = Strong Preference for Forteo B Pen	63 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package 3	5 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package 4	19 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package 5 = Strongly Agree	174 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label 2	2 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label 3	6 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label 4	25 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label 5 = Strongly Agree	165 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen 1 = Strongly Disagree	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen 2	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen 3	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen 4	16 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen 5 = Strongly Agree	180 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap 5 = Strongly Agree	182 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap 3	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap 4	15 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap 2	0 participants
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap 3	0 participants
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap 4	14 participants
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap 5 = Strongly Agree	184 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle 1 = Strongly Disagree	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle 3	5 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle 4	17 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle 5 = Strongly Agree	175 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=197 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle 2	2 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle 3	9 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle 4	18 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle 5 = Strongly Agree	168 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=197 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose 2	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose 1 = Strongly Disagree	1 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose 3	3 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose 4	9 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose 5 = Strongly Agree	183 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose 3	4 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose 4	19 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose 5 = Strongly Agree	175 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting 1 = Strongly Disagree	0 participants
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting 2	2 participants
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting 3	8 participants
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting 4	29 participants
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting 5 = Strongly Agree	159 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use 3	8 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use 4	16 participants
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use 5 = Strongly Agree	174 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use 2	0 participants
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use 3	1 participants
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use 4	18 participants
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use 5 = Strongly Agree	179 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen 1 = Very Dissatisfied	0 participants
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen 2	0 participants
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen 3	4 participants
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen 4	18 participants
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen 5 = Very Satisfied	176 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=197 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen 1 = Not At All Confident	2 participants
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen 2	4 participants
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen 3	10 participants
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen 4	32 participants
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen 5 = Very Confident	149 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use 2	1 participants
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use 3	1 participants
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use 4	19 participants
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use 5 = Strongly Agree	177 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=197 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections 1 = Strongly Disagree	3 participants
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections 2	2 participants
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections 3	14 participants
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections 4	27 participants
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections 5 = Strongly Agree	151 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home 1 = Strongly Disagree	0 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home 2	1 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home 3	3 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home 4	15 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home 5 = Strongly Agree	179 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=194 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home 1 = Strongly Disagree	2 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home 2	5 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home 3	19 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home 4	26 participants
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home 5 = Strongly Agree	142 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - Reusing Needles No	197 participants
Summary of Subject Perception (Attributes) Assessments - Reusing Needles Yes - Occasionally	0 participants
Summary of Subject Perception (Attributes) Assessments - Reusing Needles Yes - Often	0 participants
Summary of Subject Perception (Attributes) Assessments - Reusing Needles Yes - Rarely	1 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=199 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle Immediately Before Each Injection	197 participants
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle Several Hours Before Each Use	2 participants
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle At Home If Injection Is Completed Away From Home	5 participants
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle Other	0 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=198 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle Immediately	197 participants
Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle When I Get Home If Injection Completed Away	0 participants
Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle Other	1 participants

SECONDARY outcome

Timeframe: 8 weeks

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

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.

Outcome measures

Measure	Forteo B Pen Users n=199 Participants All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use Larger Print	22 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use More Color	5 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use Less Color	1 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use More Pictures	7 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use Less Pictures	3 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use More Detail in the Description	10 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use Less Detail in the Description	1 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use More Questions and Answers	11 participants
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use No Improvements Needed	156 participants

Adverse Events

Teriparatide

Serious events: 14 serious events

Other events: 134 other events

Deaths: 0 deaths

Serious adverse events

Measure	Teriparatide Teriparatide 20 micrograms per day
Blood and lymphatic system disorders Iron deficiency anaemia	0.50% 1/199 • Number of events 1
Cardiac disorders Arrhythmia	0.50% 1/199 • Number of events 1
Cardiac disorders Atrial fibrillation	0.50% 1/199 • Number of events 1
Cardiac disorders Bradycardia	0.50% 1/199 • Number of events 1
Cardiac disorders Cardiac failure congestive	0.50% 1/199 • Number of events 1
Cardiac disorders Cardiogenic shock/Death	0.50% 1/199 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.50% 1/199 • Number of events 1
Gastrointestinal disorders Intestinal obstruction	0.50% 1/199 • Number of events 1
Infections and infestations Pneumonia	0.50% 1/199 • Number of events 1
Injury, poisoning and procedural complications Ankle fracture	0.50% 1/199 • Number of events 1
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.50% 1/199 • Number of events 1
Injury, poisoning and procedural complications Upper limb fracture	0.50% 1/199 • Number of events 1
Metabolism and nutrition disorders Dehydration	0.50% 1/199 • Number of events 1
Metabolism and nutrition disorders Fluid overload	0.50% 1/199 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.50% 1/199 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.50% 1/199 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.50% 1/199 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.50% 1/199 • Number of events 1
Nervous system disorders Syncope	0.50% 1/199 • Number of events 1
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.50% 1/199 • Number of events 2

Other adverse events

Measure	Teriparatide Teriparatide 20 micrograms per day
Blood and lymphatic system disorders Anaemia	2.0% 4/199 • Number of events 4
Ear and labyrinth disorders Ear pain	1.0% 2/199 • Number of events 2
Ear and labyrinth disorders Vertigo	1.0% 2/199 • Number of events 2
Gastrointestinal disorders Abdominal pain	1.0% 2/199 • Number of events 2
Gastrointestinal disorders Gastritis	1.0% 2/199 • Number of events 2
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 4/199 • Number of events 4
Gastrointestinal disorders Nausea	4.0% 8/199 • Number of events 8
Gastrointestinal disorders Vomiting	1.5% 3/199 • Number of events 3
General disorders Fatigue	4.5% 9/199 • Number of events 9
General disorders Injection site bruising	1.0% 2/199 • Number of events 2
General disorders Injection site haemorrhage	1.0% 2/199 • Number of events 2
General disorders Non-cardiac chest pain	1.0% 2/199 • Number of events 2
General disorders Oedema peripheral	2.0% 4/199 • Number of events 4
Immune system disorders Drug hypersensitivity	1.0% 2/199 • Number of events 2
Infections and infestations Bronchitis	2.5% 5/199 • Number of events 5
Infections and infestations Gastroenteritis viral	1.5% 3/199 • Number of events 3
Infections and infestations Helicobacter infection	1.0% 2/199 • Number of events 2
Infections and infestations Influenza	2.0% 4/199 • Number of events 4
Infections and infestations Nasopharyngitis	2.0% 4/199 • Number of events 4
Infections and infestations Pneumonia	1.0% 2/199 • Number of events 2
Infections and infestations Sinusitis	3.5% 7/199 • Number of events 7
Infections and infestations Upper respiratory tract infection	6.0% 12/199 • Number of events 13
Infections and infestations Urinary tract infection	4.0% 8/199 • Number of events 10
Injury, poisoning and procedural complications Back injury	1.0% 2/199 • Number of events 2
Injury, poisoning and procedural complications Contusion	4.0% 8/199 • Number of events 9
Injury, poisoning and procedural complications Excoriation	1.0% 2/199 • Number of events 3
Injury, poisoning and procedural complications Fall	1.0% 2/199 • Number of events 2
Injury, poisoning and procedural complications Joint sprain	1.0% 2/199 • Number of events 2
Injury, poisoning and procedural complications Procedural pain	1.0% 2/199 • Number of events 2
Investigations Colonoscopy	1.0% 2/199 • Number of events 2
Investigations Heart rate irregular	1.0% 2/199 • Number of events 2
Investigations Vitamin D decreased	1.0% 2/199 • Number of events 2
Investigations Weight decreased	1.5% 3/199 • Number of events 3
Metabolism and nutrition disorders Hypercalcaemia	1.0% 2/199 • Number of events 2
Metabolism and nutrition disorders Hypercholesterolaemia	1.0% 2/199 • Number of events 2
Metabolism and nutrition disorders Vitamin D deficiency	1.0% 2/199 • Number of events 2
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 9/199 • Number of events 9
Musculoskeletal and connective tissue disorders Back pain	4.0% 8/199 • Number of events 8
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.0% 2/199 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle spasms	1.5% 3/199 • Number of events 4
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.5% 7/199 • Number of events 7
Musculoskeletal and connective tissue disorders Myalgia	1.5% 3/199 • Number of events 4
Musculoskeletal and connective tissue disorders Osteoarthritis	2.5% 5/199 • Number of events 5
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 4/199 • Number of events 4
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.0% 2/199 • Number of events 2
Musculoskeletal and connective tissue disorders Scoliosis	1.0% 2/199 • Number of events 2
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.5% 3/199 • Number of events 3
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	1.0% 2/199 • Number of events 2
Nervous system disorders Dizziness	4.0% 8/199 • Number of events 8
Nervous system disorders Headache	3.0% 6/199 • Number of events 6
Nervous system disorders Tremor	1.0% 2/199 • Number of events 2
Psychiatric disorders Depression	2.0% 4/199 • Number of events 4
Psychiatric disorders Insomnia	1.0% 2/199 • Number of events 2
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 3/199 • Number of events 3
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 2/199 • Number of events 2
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	1.0% 2/199 • Number of events 2
Skin and subcutaneous tissue disorders Rash	2.0% 4/199 • Number of events 6
Surgical and medical procedures Dental prosthesis placement	1.0% 2/199 • Number of events 2
Surgical and medical procedures Joint arthroplasty	1.0% 2/199 • Number of events 2

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60