Phase 3
N=200
Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00577863 ↗Enrolled (actual)
200
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Summary of Forteo B Pen Complaints at 8 Weeks — 47; 4; 27; 8 number of complaints
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- teriparatide (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Forteo B Pen Complaints at 8 Weeks |
47; 4; 27; 8; 16; 7 | — |
| PRIMARY Number of Subjects With Forteo B Pen Complaints at 8 Weeks |
31; 4; 19; 8; 14; 7 | — |
| PRIMARY Summary of Forteo B Pen Complaints at 46 Weeks |
58; 9; 6; 32; 8; 17 | — |
| PRIMARY Number of Subjects With Forteo B Pen Complaints at 46 Weeks |
37; 9; 6; 21; 8; 14 | — |
| SECONDARY Summary of Subject Preference Assessments - Overall Preference |
2; 1; 4; 6; 79 | — |
| SECONDARY Summary of Subject Preference Assessments - Learning to Use the Pen |
2; 0; 8; 7; 75 | — |
| SECONDARY Summary of Subject Preference Assessments - Attaching a New Needle |
2; 0; 36; 8; 46 | — |
| SECONDARY Summary of Subject Preference Assessments - Setting the Dose |
2; 0; 3; 8; 79 | — |
| SECONDARY Summary of Subject Preference Assessments - Injecting a Dose |
2; 1; 16; 6; 67 | — |
| SECONDARY Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose |
2; 3; 14; 11; 62 | — |
| SECONDARY Summary of Subject Preference Assessments - Assurance That Drug is Delivered |
4; 3; 23; 16; 46 | — |
| SECONDARY Summary of Subject Preference Assessments - Removing a Used Needle |
3; 1; 36; 7; 45 | — |
| SECONDARY Summary of Subject Preference Assessments - Overall Ease of Use |
1; 3; 4; 3; 81 | — |
| SECONDARY Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen |
3; 2; 15; 9; 63 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package |
0; 0; 5; 19; 174 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Read Label |
0; 2; 6; 25; 165 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen |
1; 1; 0; 16; 180 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap |
0; 0; 1; 15; 182 | — |
| SECONDARY Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap |
0; 0; 0; 14; 184 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle |
1; 0; 5; 17; 175 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle |
0; 2; 9; 18; 168 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose |
1; 1; 3; 9; 183 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose |
0; 0; 4; 19; 175 | — |
| SECONDARY Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting |
0; 2; 8; 29; 159 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use |
0; 0; 8; 16; 174 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use |
0; 0; 1; 18; 179 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen |
0; 0; 4; 18; 176 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen |
2; 4; 10; 32; 149 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use |
0; 1; 1; 19; 177 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections |
3; 2; 14; 27; 151 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home |
0; 1; 3; 15; 179 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home |
2; 5; 19; 26; 142 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - Reusing Needles |
197; 0; 0; 1 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle |
197; 2; 5; 0 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle |
197; 0; 1 | — |
| SECONDARY Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use |
22; 5; 1; 7; 3; 10 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00577863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.