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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-MC-GHDF |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Forteo B Pen Complaints at 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 46 weeks |
| 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. | 46 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Subject Preference Assessments - Overall Preference | 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. | 4 weeks |
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Inclusion Criteria:
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.
Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
Able to read, understand, and respond to self-administered questionnaires.
Without language barrier, cooperative, and expected to return for all follow-up procedures.
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:
Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 35801 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19656016 | Derived | Dore RK, Feldman RG, Taylor KA, See K, Dalsky GP, Warner MR. Patient experience with a new teriparatide delivery device. Curr Med Res Opin. 2009 Oct;25(10):2413-22. doi: 10.1185/03007990903173074. |
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Results are reported for participants who received at least one injection of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Summary of Subject Preference Assessments - Learning to Use the Pen |
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. |
| 4 weeks |
| Summary of Subject Preference Assessments - Attaching a New Needle | 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 weeks |
| Summary of Subject Preference Assessments - Setting the Dose | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Injecting a Dose | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Assurance That Drug is Delivered | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Removing a Used Needle | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Overall Ease of Use | 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. | 4 weeks |
| Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen | 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. | 4 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Read Label | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Remove 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 remove the pen cap. | 8 weeks |
| 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose | 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. | 8 weeks |
| Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - Reusing Needles | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle | 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. | 8 weeks |
| Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use | 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. | 8 weeks |
| United States |
| 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 | 36111 | United States |
| 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 | 85381 | United States |
| 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 | 90211 | United States |
| 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 | 92653 | United States |
| 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 | 92780 | United States |
| 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 | 06611 | United States |
| 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 | 34684 | United States |
| 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. | South Miami | Florida | 33143 | United States |
| 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 | 30033 | United States |
| 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 | 30501 | United States |
| 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 | 20902 | United States |
| 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 | 12206 | United States |
| 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 | 28801 | United States |
| 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 | 45219 | United States |
| 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 | 24541 | United States |
| 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 | 98405 | United States |
| 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 | 25801 | United States |
| 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. |
| Received at Least One Injection |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Previous Teriparatide Use | Number | participants |
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| Race/Ethnicity | Number | participants |
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| Duration of Prior Forteo 1.1 Pen Experience | Mean | Standard Deviation | weeks |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Forteo B Pen Complaints at 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. | All participants who received at least one injection of study drug. | Posted | Number | number of complaints | 8 weeks |
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| Secondary | Summary of Subject Preference Assessments - Overall Preference | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Learning to Use the Pen | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| 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. | All participants who received at least one injection of study drug. | Posted | Number | number of participants with complaints | 8 weeks |
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| Secondary | Summary of Subject Preference Assessments - Attaching a New Needle | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Setting the Dose | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Injecting a Dose | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Assurance That Drug is Delivered | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Removing a Used Needle | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Overall Ease of Use | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen | 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. | All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question. | Posted | Number | participants | 4 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Read Label | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Remove 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 remove the pen cap. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - Reusing Needles | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| Secondary | Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use | 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. | All participants who received at least one injection of study drug and who answered the question. | Posted | Number | participants | 8 weeks |
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| 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. | All participants who received at least one injection of study drug. | Posted | Number | number of complaints | 46 weeks |
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| 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. | All participants who received at least one injection of study drug. | Posted | Number | number of participants with complaints | 46 weeks |
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Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide | Teriparatide 20 micrograms per day | 14 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiogenic shock/Death | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Colonoscopy | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dental prosthesis placement | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Joint arthroplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
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| No |
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| African |
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| Hispanic |
|
| East Asian |
|
| Title | Measurements |
|---|---|
|
| Nonfunctional (4%): Pen too large, awkward, bulky |
|
| Complaint Category: User Manual Related |
|
| User Manual (3.5%): No information on alcohol swab |
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