Clinical trial NCT00577863: Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
Official title: B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Summary of Forteo B Pen Complaints at 8 Weeks
timeFrame: 8 weeks
measure: Number of Subjects With Forteo B Pen Complaints at 8 Weeks
timeFrame: 8 weeks
measure: Summary of Forteo B Pen Complaints at 46 Weeks
timeFrame: 46 weeks
measure: Number of Subjects With Forteo B Pen Complaints at 46 Weeks
timeFrame: 46 weeks
Secondary outcomes:
measure: Summary of Subject Preference Assessments - Overall Preference
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Learning to Use the Pen
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Attaching a New Needle
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Setting the Dose
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Injecting a Dose
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Assurance That Drug is Delivered
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Removing a Used Needle
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Overall Ease of Use
timeFrame: 4 weeks
measure: Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen
timeFrame: 4 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Read Label
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose
timeFrame: 8 weeks
measure: Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - Reusing Needles
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle
timeFrame: 8 weeks
measure: Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 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.
state: Alabama
city: Montgomery
country: United States
facility: 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.
state: Alabama
city: Peoria
country: United States
facility: 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.
state: Arizona
city: Beverly Hills
country: United States
facility: 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.
state: California
city: Laguna Hills
country: United States
facility: 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.
state: California
city: Tustin
country: United States
facility: 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.
state: California
city: Trumbull
country: United States
facility: 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.
state: Connecticut
city: Palm Harbor
country: United States
facility: 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.
state: Florida
city: S. Miami
country: United States
facility: 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.
state: Florida
city: Decatur
country: United States
facility: 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.
state: Georgia
city: Gainesville
country: United States
facility: 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.
state: Georgia
city: Wheaton
country: United States
facility: 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.
state: Maryland
city: Albany
country: United States
facility: 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.
state: New York
city: Asheville
country: United States
facility: 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.
state: North Carolina
city: Cincinnati
country: United States
facility: 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.
state: Ohio
city: Danville
country: United States
facility: 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.
state: Virginia
city: Tacoma
country: United States
facility: 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.
state: Washington
city: Beckley
country: United States
facility: 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.
state: West Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.