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

Condition(s) targeted: Osteoporosis

Intervention: teriparatide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Summary of Forteo B Pen Complaints at 8 Weeks

Number of Subjects With Forteo B Pen Complaints at 8 Weeks

Summary of Forteo B Pen Complaints at 46 Weeks

Number of Subjects With Forteo B Pen Complaints at 46 Weeks

Secondary outcome:

Summary of Subject Preference Assessments - Overall Preference

Summary of Subject Preference Assessments - Learning to Use the Pen

Summary of Subject Preference Assessments - Attaching a New Needle

Summary of Subject Preference Assessments - Setting the Dose

Summary of Subject Preference Assessments - Injecting a Dose

Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose

Summary of Subject Preference Assessments - Assurance That Drug is Delivered

Summary of Subject Preference Assessments - Removing a Used Needle

Summary of Subject Preference Assessments - Overall Ease of Use

Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen

Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package

Summary of Subject Perception (Attributes) Assessments - Easy to Read Label

Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen

Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap

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

Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle

Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle

Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose

Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose

Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting

Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use

Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use

Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied 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

Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use

Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections

Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home

Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home

Summary of Subject Perception (Attributes) Assessments - Reusing Needles

Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle

Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle

Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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, 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., S. 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

Lilly Clinical Trial Registry

Starting date: January 2008
Last updated: July 13, 2009