Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: teriparatide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy |
- Summary of Forteo B Pen Complaints at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Number of Subjects With Forteo B Pen Complaints at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Forteo B Pen Complaints at 46 Weeks [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
- Number of Subjects With Forteo B Pen Complaints at 46 Weeks [ Time Frame: 46 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Overall Preference [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Learning to Use the Pen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Attaching a New Needle [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Setting the Dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Injecting a Dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Assurance That Drug is Delivered [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Removing a Used Needle [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Overall Ease of Use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Read Label [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - Reusing Needles [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
-
Drug: teriparatide
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Alabama | |
| 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, United States, 35801 | |
| 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, United States, 36111 | |
| United States, Arizona | |
| 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, United States, 85381 | |
| United States, California | |
| 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, United States, 90211 | |
| 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, United States, 92653 | |
| 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, United States, 92780 | |
| United States, Connecticut | |
| 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, United States, 06611 | |
| United States, Florida | |
| 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, United States, 34684 | |
| 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. | |
| S. Miami, Florida, United States, 33143 | |
| United States, Georgia | |
| 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, United States, 30033 | |
| 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, United States, 30501 | |
| United States, Maryland | |
| 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, United States, 20902 | |
| United States, New York | |
| 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, United States, 12206 | |
| United States, North Carolina | |
| 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, United States, 28801 | |
| United States, Ohio | |
| 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, United States, 45219 | |
| United States, Virginia | |
| 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, United States, 24541 | |
| United States, Washington | |
| 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, United States, 98405 | |
| United States, West Virginia | |
| 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, United States, 25801 | |
| Study Director: | 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 |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00577863 History of Changes |
| Other Study ID Numbers: | 10586, B3D-MC-GHDF |
| Study First Received: | December 18, 2007 |
| Results First Received: | May 5, 2009 |
| Last Updated: | July 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013