OsteoporosisPhase 3NCT00577863
Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
A Phase 3 study testing teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- teriparatide
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
- Able to read, understand, and respond to self-administered questionnaires.
- Without language barrier, cooperative, and expected to return for all follow-up procedures.
- 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.
Who cannot join
- Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
- Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
- 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.
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
South Miami, Florida, 33143
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
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
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
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
About this study
Official title: 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.
- Conditions
- Osteoporosis
- Being tested
- teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriparatideDrug
Also called LY333334
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Forteo B Pen Complaints at 8 Weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Measured: 8 weeks
Number of Subjects With Forteo B Pen Complaints at 8 Weeks
Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Measured: 8 weeks
Summary of Forteo B Pen Complaints at 46 Weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Measured: 46 weeks
Number of Subjects With Forteo B Pen Complaints at 46 Weeks
Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Measured: 46 weeks
Secondary outcomes (32)
Summary of Subject Preference Assessments - Overall Preference
To assess overall 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Learning to Use the Pen
To assess subject preferences for learning to use the pen 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Attaching a New Needle
To assess subject preferences for attaching a new needle 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Setting the Dose
To assess subject preferences for setting the dose 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Injecting a Dose
To assess subject preferences for injecting a dose 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose
To assess subject preferences for force on the plunger needed to inject a dose 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Assurance That Drug is Delivered
To assess subject preferences for assurance that drug is delivered 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Removing a Used Needle
To assess subject preferences for removing a used needle 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Overall Ease of Use
To assess subject preferences for overall ease of use 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.
Measured: 4 weeks
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen
To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen 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.
Measured: 4 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.
Measured: 8 weeks
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.
Measured: 8 weeks
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to use the Forteo B Pen Instructions for Use.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how satisfied they were with the Forteo B Pen.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how confident they were that they received the medication with the Forteo B Pen.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how convenient Forteo B Pen was to use.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Reusing Needles
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.
Measured: 8 weeks
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use
To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577863
- Sponsor's protocol ID
- 10586
- Other IDs
- B3D-MC-GHDF
- Status last verified
- Jul 2009
- First submitted
- 18 Dec 2007
- Last updated
- 22 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19656016
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B3D-MC-GHDF: Community Experience of Subjects With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
- ClinicalTrials.gov ID
- NCT00577863
- Acronym / sponsor ID
- 10586
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 24 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Willing to be trained and use the pen-injector daily to the satisfaction of study site personnel.
- Able to read, understand, and respond to self-administered questionnaires.
- Without language barrier, cooperative, and expected to return for all follow-up procedures.
- 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.
Key exclusion criteria (4 listed)
- Any disease of sufficient severity to preclude treatment with teriparatide or participation in and completion of the study as defined by the investigator.
- Having laboratory values, such as elevated serum calcium, precluding teriparatide treatment as defined by the investigator.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teriparatideAlso: LY333334Subcutaneous 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. | Drug | – |
Primary outcome
Summary of Forteo B Pen Complaints at 8 Weeks
Time frame: 8 weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Number of Subjects With Forteo B Pen Complaints at 8 Weeks
Time frame: 8 weeks
Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Summary of Forteo B Pen Complaints at 46 Weeks
Time frame: 46 weeks
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Number of Subjects With Forteo B Pen Complaints at 46 Weeks
Time frame: 46 weeks
Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
32 secondary outcomes
Summary of Subject Preference Assessments - Overall Preference
Time frame: 4 weeks
Summary of Subject Preference Assessments - Learning to Use the Pen
Time frame: 4 weeks
Summary of Subject Preference Assessments - Attaching a New Needle
Time frame: 4 weeks
Summary of Subject Preference Assessments - Setting the Dose
Time frame: 4 weeks
Summary of Subject Preference Assessments - Injecting a Dose
Time frame: 4 weeks
Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose
Time frame: 4 weeks
Summary of Subject Preference Assessments - Assurance That Drug is Delivered
Time frame: 4 weeks
Summary of Subject Preference Assessments - Removing a Used Needle
Time frame: 4 weeks
Summary of Subject Preference Assessments - Overall Ease of Use
Time frame: 4 weeks
Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen
Time frame: 4 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Read Label
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap
Time frame: 8 weeks
Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose
Time frame: 8 weeks
Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - Reusing Needles
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle
Time frame: 8 weeks
Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19656016Dore 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Eli Lilly and Company
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of Forteo B Pen Complaints at 8 Weeks (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00577863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.