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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00577863
First received: December 18, 2007
Last updated: July 13, 2009
Last verified: July 2009
  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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    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.
    Other Name: LY333334
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577863

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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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 August 27, 2014