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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577863
• Other study ID #: 10586
• Secondary ID: B3D-MC-GHDF
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: July 13, 2009
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.

Locations

Country	Name	City	State
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
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
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
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
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
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
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
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
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.	Huntsville	Alabama
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
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
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
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
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
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
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
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Forteo B Pen Complaints at 8 Weeks		8 weeks	Yes
Primary	Number of Subjects With Forteo B Pen Complaints at 8 Weeks		8 weeks	No
Primary	Summary of Forteo B Pen Complaints at 46 Weeks		46 weeks	No
Primary	Number of Subjects With Forteo B Pen Complaints at 46 Weeks		46 weeks	No
Secondary	Summary of Subject Preference Assessments - Overall Preference		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Learning to Use the Pen		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Attaching a New Needle		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Setting the Dose		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Injecting a Dose		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Assurance That Drug is Delivered		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Removing a Used Needle		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Overall Ease of Use		4 weeks	No
Secondary	Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen		4 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Read Label		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap		8 weeks	No
Secondary	Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose		8 weeks	No
Secondary	Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - Reusing Needles		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle		8 weeks	No
Secondary	Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use		8 weeks	No

External Links

•   Lilly Clinical Trial Registry