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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

December 18, 2007
July 13, 2009
January 2008
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
To collect complaint data from patients in the community setting using the Forteo B Pen. In particular, the objective is to detect common complaints, which are any complaints that have at least 3% complaint rate in subjects using the Forteo B Pen. [ Time Frame: At 8 weeks and end of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00577863 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To assess subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To collect adverse events in subjects self-administering teriparatide via the Forteo B Pen. [ Time Frame: 8 weeks and end of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
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
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577863
10586, B3D-MC-GHDF
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP