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

B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577863

Enrollment

200

Registered

2007-12-20

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2009-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGteriparatide

Subcutaneous injection of teriparatide 20 micrograms once daily using the Forteo B Pen. The primary phase of the study is 8 weeks after which time patients may participate in a study extension until the patient completes their maximum duration of teriparatide therapy or the Forteo B Pen becomes commercially available.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Men with primary or hypogonadal osteoporosis or postmenopausal women with osteoporosis in the opinion of the investigator. Subjects must be at high risk for fracture in the opinion of the investigator. 2. Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel. 3. Able to read, understand, and respond to self-administered questionnaires. 4. Without language barrier, cooperative, and expected to return for all follow-up procedures. 5. Have provided written informed consent to participate in this study, according to local regulations after being informed of the risks, medications, and procedures to be used in the study.

Exclusion criteria

6. Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator. 7. Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator. 8. Subjects who have an increased baseline risk of osteosarcoma, including those with: Paget's disease of the bone or unexplained elevations of alkaline phosphatase, children and young adults with open epiphyses, and subjects who have received external beam or implant radiation therapy involving the skeleton. 9. History of malignant neoplasms in the 5 years prior to study entry, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated, or history of carcinoma in situ of the cervix or uterus.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
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.	92
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.	107
Total	199

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	2
Overall Study	Death	1	0
Overall Study	Did Not Receive at Least One Injection	0	1
Overall Study	Entry Criteria Exclusion	1	0
Overall Study	Lost to Follow-up	2	2
Overall Study	Sponsor Decision	2	7
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Current Users	Not Current Users	Total
Age Continuous	67.1 years STANDARD_DEVIATION 11.01	68.5 years STANDARD_DEVIATION 11.54	67.9 years STANDARD_DEVIATION 11.3
Duration of Prior Forteo 1.1 Pen Experience	36.5 weeks STANDARD_DEVIATION 23.01	12.9 weeks STANDARD_DEVIATION 16.33	31.2 weeks STANDARD_DEVIATION 23.78
Previous Teriparatide Use No	0 participants	80 participants	80 participants
Previous Teriparatide Use Yes	92 participants	27 participants	119 participants
Race/Ethnicity African	0 participants	1 participants	1 participants
Race/Ethnicity Caucasian	87 participants	104 participants	191 participants
Race/Ethnicity East Asian	3 participants	1 participants	4 participants
Race/Ethnicity Hispanic	2 participants	1 participants	3 participants
Region of Enrollment United States	92 participants	107 participants	199 participants
Sex: Female, Male Female	82 Participants	96 Participants	178 Participants
Sex: Female, Male Male	10 Participants	11 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	134 / —
serious Total, serious adverse events	14 / —

Outcome results

Primary

Number of Subjects With Forteo B Pen Complaints at 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.

Time frame: 46 weeks

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

Arm	Measure	Group	Value (NUMBER)
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	All Complaints	37 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	Complaint Category: Functional	9 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	Functional (3%): Stopped working, wouldn't inject	6 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	Complaint Category: Nonfunctional	21 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	Nonfunctional (4%): Pen too large, awkward, bulky	8 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	Complaint Category: User Manual Related	14 number of participants with complaints
Forteo B Pen Users	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

Primary

Number of Subjects With Forteo B Pen Complaints at 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.

Time frame: 8 weeks

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

Arm	Measure	Group	Value (NUMBER)
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	All Complaints	31 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	Complaint Category: Functional	4 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	Complaint Category: Nonfunctional	19 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	Nonfunctional (4%): Pen too large, awkward, bulky	8 number of participants with complaints
Forteo B Pen Users	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	Complaint Category: User Manual Related	14 number of participants with complaints
Forteo B Pen Users	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

Summary of Forteo B Pen Complaints at 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.

Time frame: 46 weeks

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

Arm	Measure	Group	Value (NUMBER)
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	All Complaints	58 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	Complaint Category: Functional	9 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	Functional (3%): Stopped working, wouldn't inject	6 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	Complaint Category: Nonfunctional	32 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	Nonfunctional (4%): Pen too large, awkward, bulky	8 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	Complaint Category: User Manual Related	17 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 46 Weeks	User Manual (3.5%): No information on alcohol swab	7 number of complaints

Primary

Summary of Forteo B Pen Complaints at 8 Weeks

Time frame: 8 weeks

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

Arm	Measure	Group	Value (NUMBER)
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	All Complaints	47 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	Complaint Category: Functional	4 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	Complaint Category: Nonfunctional	27 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	Nonfunctional (4%): Pen too large, awkward, bulky	8 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	Complaint Category: User Manual Related	16 number of complaints
Forteo B Pen Users	Summary of Forteo B Pen Complaints at 8 Weeks	User Manual (3.5%): No information on alcohol swab	7 number of complaints

Secondary

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

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