Trial · NCT00577863

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

NCT00577863, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-06-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy. Trials, record NCT00577863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00577863

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy
NCT number: NCT00577863
Status: Completed
Phases: Phase 3
Enrollment: 200 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Osteoporosis
Interventions: teriparatide
First posted: 2007-12-20
Last updated: 2009-07-22
Results first posted: 2009-06-24

Source ClinicalTrials.gov

Registered outcomes36

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Summary of Forteo B Pen Complaints at 8 Weeks	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.
Primary	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	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.
Primary	Summary of Forteo B Pen Complaints at 46 Weeks	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.
Primary	Number of Subjects With Forteo B Pen Complaints at 46 Weeks	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.
Secondary	Summary of Subject Preference Assessments - Overall Preference	4 weeks	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.
Secondary	Summary of Subject Preference Assessments - Learning to Use the Pen	4 weeks	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.
Secondary	Summary of Subject Preference Assessments - Attaching a New Needle	4 weeks	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.
Secondary	Summary of Subject Preference Assessments - Setting the Dose	4 weeks	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.
Secondary	Summary of Subject Preference Assessments - Injecting a Dose	4 weeks	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.
Secondary	Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose	4 weeks	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.

1 to 10 of 36Source ClinicalTrials.gov

See all 36 registered outcomes

Outcomes36

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Summary of Forteo B Pen Complaints at 8 Weeks	8 weeks	All participants who received at least one injection of study drug.	number of complaints	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Overall Preference	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Learning to Use the Pen	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
PRIMARY	Number of Subjects With Forteo B Pen Complaints at 8 Weeks	8 weeks	All participants who received at least one injection of study drug.	number of participants with complaints	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Attaching a New Needle	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Setting the Dose	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Injecting a Dose	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Assurance That Drug is Delivered	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER
SECONDARY	Summary of Subject Preference Assessments - Removing a Used Needle	4 weeks	All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.	participants	NUMBER

1 to 10 of 36Source ClinicalTrials.gov

See all 36 outcomes

Results by group186

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	All Complaints	47	number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	Complaint Category: Functional	4	number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	Complaint Category: Nonfunctional	27	number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	Nonfunctional (4%): Pen too large, awkward, bulky	8	number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	Complaint Category: User Manual Related	16	number of complaints
Summary of Forteo B Pen Complaints at 8 Weeks	Forteo B Pen Users	User Manual (3.5%): No information on alcohol swab	7	number of complaints
Summary of Subject Preference Assessments - Overall Preference	Forteo 1.1 Pen Users	1 = Strong Preference for Forteo 1.1 Pen	2	participants
Summary of Subject Preference Assessments - Overall Preference	Forteo 1.1 Pen Users	2	1	participants
Summary of Subject Preference Assessments - Overall Preference	Forteo 1.1 Pen Users	3 = No Preference	4	participants
Summary of Subject Preference Assessments - Overall Preference	Forteo 1.1 Pen Users	4	6	participants

1 to 10 of 186Source ClinicalTrials.gov

See all 186 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Current Users	92
Overall Study	STARTED	Not Current Users	108
Overall Study	Received at Least One Injection	Current Users	92
Overall Study	Received at Least One Injection	Not Current Users	107
Overall Study	COMPLETED	Current Users	82
Overall Study	COMPLETED	Not Current Users	94
Overall Study	NOT COMPLETED	Current Users	10
Overall Study	NOT COMPLETED	Not Current Users	14

Source ClinicalTrials.gov

Adverse events79

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Teriparatide	4	199	4
other	Ear pain	Ear and labyrinth disorders	Teriparatide	2	199	2
other	Vertigo	Ear and labyrinth disorders	Teriparatide	2	199	2
other	Abdominal pain	Gastrointestinal disorders	Teriparatide	2	199	2
other	Gastritis	Gastrointestinal disorders	Teriparatide	2	199	2
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Teriparatide	4	199	4
other	Nausea	Gastrointestinal disorders	Teriparatide	8	199	8
other	Vomiting	Gastrointestinal disorders	Teriparatide	3	199	3
other	Fatigue	General disorders	Teriparatide	9	199	9
other	Injection site bruising	General disorders	Teriparatide	2	199	2

1 to 10 of 79Source ClinicalTrials.gov

See all 79 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Teriparatide
Total, other adverse events	Teriparatide	134
Total, serious adverse events	Teriparatide	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19656016	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00577863

GET https://conductscience.org/api/trials/v1/NCT00577863/registered?page=2

API reference For AI assistants