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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: teriparatide


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: teriparatide|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |