This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy (NCT00577863), a non-randomized phase 3 study. The primary outcome is Summary of Forteo B Pen Complaints at 8 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00577863 |
| Phase | Phase 3 |
| Condition | Osteoporosis |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with osteoporosis who received at least one injection of study drug. The registry lists enrollment of 200, but the number who received an injection and contributed to the primary outcome is not reported in the registry record.
Intervention
Teriparatide self-administered with the Forteo B Pen in a community setting. The study was intended to collect patients’ experiences using the pen, including complaints and preferences about aspects of its use.
Comparator
There was no comparator group. The study is described as non-randomized and single-group, so it does not provide a like-for-like control comparison.
Primary question
What number and types of complaints were reported by participants using the Forteo B Pen at 8 weeks? The registry also describes common complaints as those reaching at least 3% complaint rate.
The question is about experience with a self-administration device, not a comparison of teriparatide with another treatment. The registry describes functional complaints as related to device malfunction, and nonfunctional complaints as related to cosmetic or perception concerns. That distinction frames the kinds of issues the complaint assessment was meant to capture.
Preference assessments were also listed for overall preference and specific tasks: learning to use the pen, attaching a new needle, setting the dose, injecting a dose, the force needed on the plunger, assurance that drug was delivered, and removing a used needle. These assessments broaden the focus from complaints to patient experience, but their results are not reported in the registry record. The primary complaint counts and the preference results therefore cannot establish how participants rated the device or how frequently particular problems occurred.
3. Trial Design
This was a phase 3, non-randomized, unmasked, single-group study sponsored by Eli Lilly and Company. The registry lists enrollment of 200 and status as completed. The recorded study start is 2008-01, and primary completion is recorded as 2008-05. These design features describe the study’s structure; they do not establish that the enrolled participants all received an injection or contributed data to the primary outcome.
Participants with osteoporosis used teriparatide with the Forteo B Pen to self-administer treatment in a community setting. The primary outcome population is defined as all participants who received at least one injection of study drug. The number in that population is not reported in the registry record. Because there was a single group and no masking, the study was structured to collect experience and complaints during use rather than to compare outcomes under blinded or randomized treatment assignments.
The registry’s stated purpose was to gather information about patients’ experience using the pen. It says the information would be used to assess whether changes were needed to the user manual and patient educational tools, and to assess the pen’s acceptability for commercial launch. Those aims are consistent with a device-use and experience study. They should not be read as evidence that the study tested comparative efficacy or established the effect of the drug relative to another treatment.
The record lists 36 outcome measures, including the primary complaint outcome and preference assessments. It lists 0 statistical analyses. The detailed protocol, recruitment procedures, complaint-collection process, and statistical analysis plan are not reported in the registry record. The sample-size justification is also not reported in the registry record, so the listed enrollment should not be interpreted as a documented calculation tied to a target precision or statistical power.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Results are reported for participants who received at least one injection of study drug.
Overall Study
| Stage | Current Users | Not Current Users |
|---|---|---|
| STARTED | 92 | 108 |
| Received at Least One Injection | 92 | 107 |
| COMPLETED | 82 | 94 |
| NOT COMPLETED | 10 | 14 |
Reasons for not completing this period:
| Reason | Current Users | Not Current Users |
|---|---|---|
| Adverse Event | 4 | 2 |
| Death | 1 | 0 |
| Lost to Follow-up | 2 | 2 |
| Entry Criteria Exclusion | 1 | 0 |
| Withdrawal by Subject | 0 | 2 |
| Sponsor Decision | 2 | 7 |
| Did Not Receive at Least One Injection | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one injection of study drug.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Current Users | Not Current Users | Total |
|---|---|---|---|---|
| Participants analysed | 92 | 107 | 199 | |
| Age Continuous | years | 67.1 (SD 11.01) | 68.5 (SD 11.54) | 67.9 (SD 11.30) |
| Sex: Female, Male: Female | Participants | 82 | 96 | 178 |
| Sex: Female, Male: Male | Participants | 10 | 11 | 21 |
| Region of Enrollment: United States | participants | 92 | 107 | 199 |
| Previous Teriparatide Use: Yes | participants | 92 | 27 | 119 |
| Previous Teriparatide Use: No | participants | 0 | 80 | 80 |
| Race/Ethnicity: Caucasian | participants | 87 | 104 | 191 |
| Race/Ethnicity: African | participants | 0 | 1 | 1 |
| Race/Ethnicity: Hispanic | participants | 2 | 1 | 3 |
| Race/Ethnicity: East Asian | participants | 3 | 1 | 4 |
| Duration of Prior Forteo 1.1 Pen Experience | weeks | 36.5 (SD 23.01) | 12.9 (SD 16.33) | 31.2 (SD 23.78) |
6. Primary Endpoint
The registry lists the primary outcome as Summary of Forteo B Pen Complaints at 8 Weeks, measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of complaints |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is the number of complaints at 8 weeks among participants who received at least one injection of study drug. The description separates functional complaints, which relate to device malfunction, from nonfunctional complaints, which relate to cosmetic or perception concerns. It also identifies common complaints using a threshold of at least 3% complaint rate.
A complaint count can describe the volume of reported issues and, when complaint categories are recorded consistently, the kinds of issues participants raise. In a device-use study, this can help characterize practical experience in the setting in which the device is intended to be used. The registry states that the information was intended to inform the user manual, patient educational tools, and assessment of acceptability for commercial launch.
The endpoint does not, by itself, measure comparative treatment benefit. Nor does a count alone tell a reader how many participants were exposed to the device, whether multiple complaints came from the same participant, or how complete complaint reporting was. Those details, along with the observed complaint count and category breakdown, are not reported in the registry record. Consequently, the endpoint’s purpose is clear, but its numerical result and precision cannot be assessed from the registry information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a patient-experience question and defines a primary outcome, but it does not report the observed number of complaints at 8 weeks. It therefore does not support a quantitative statement about how many complaints occurred, which complaint categories were most frequent, or how precisely those frequencies were estimated. The definition of common complaints as those with at least 3% complaint rate is a criterion for classification, not a reported finding that any complaint met that criterion.
The study’s single-group structure matters for interpretation. It can describe complaints and preferences recorded among participants who used the Forteo B Pen, but it does not provide a concurrent control group for distinguishing device-related experience from other influences. The record specifically identifies the allocation as non-randomized and indicates that the arms are not a like-for-like control comparison. In this study, no control arm is described. Any account of the results should therefore remain descriptive rather than framing the findings as a comparative treatment effect.
The primary outcome population is participants who received at least one injection, but the number in that population is not reported in the registry record. Enrollment is listed as 200; that figure does not establish the analyzed population size. Without the number contributing outcome data, the complaint count, and information about missing observations, readers cannot judge the completeness or precision of the primary outcome assessment.
The registry also lists 14 participants affected by serious adverse events and 134 affected by other adverse events in the teriparatide group. The corresponding numbers at risk are not reported in the registry record. Serious-event terms listed include Iron deficiency anaemia, Arrhythmia, Atrial fibrillation, Bradycardia, Cardiac failure congestive, and Cardiogenic shock/Death, each shown with 0.5%. These safety entries do not supply the missing primary complaint results, and the available information does not allow calculation of event rates or comparison with another group.
There are 36 outcome measures listed and 0 statistical analyses. The registry does not report inferential results, confidence intervals, p-values, or an analysis plan. Thus, the record supports a description of the study’s intended assessment and design, but not a conclusion about the frequency of complaints, the precision of the estimates, or the statistical evidence for any difference.
9. Statistical Methods Explained
The primary outcome is a count: the number of complaints recorded at 8 weeks. General statistical context is useful for understanding what such an endpoint can and cannot convey. A count summarizes how many events or reports were recorded, while a complaint rate relates that count to an exposure or population denominator. The registry gives a threshold of at least 3% for describing common complaints, but the number of complaints, the denominator used for that rate, and the category-specific results are not reported in the registry record.
What does a count analysis need to define?
General statistical principle: a count outcome is interpretable only when the counted event and observation window are defined clearly. For a complaint assessment, relevant details include what qualified as a complaint, how repeat complaints were handled, how reports were assigned to functional or nonfunctional categories, and whether reports were collected for every participant over the same period. The registry supplies the broad category definitions and the 8-week timeframe, but further operational details are not reported in the registry record.
A count can also be presented at the participant level or as a total across all participants. Those summaries answer different questions. A participant-level summary can describe how complaints were distributed among people; a total count describes the overall number of reports. The registry’s endpoint is titled as a summary of the number of complaints, but the exact reporting format and the handling of multiple complaints from one participant are not reported in the registry record. It would be inappropriate to infer those details from the outcome title.
Why can count data be more variable than expected?
General statistical principle: count models often begin with assumptions about the relationship between the average count and its variability. Over-dispersion occurs when the observed variability is greater than a model assumes. If over-dispersion is present but ignored, uncertainty may be understated and statistical tests may be too optimistic. Complaint counts could vary across participants because of differences in exposure, reporting, or experience, but the registry does not report a model, a dispersion assessment, or any analysis of that kind. These are general considerations, not methods reported for this study.
General statistical principle: a count distribution can also contain more zero values than a standard model expects, a feature sometimes called zero inflation. Whether that issue is relevant depends on how complaints were recorded and on the observed data. The registry does not report the distribution of complaint counts, so it is not possible to assess this feature or say that a zero-inflated method was needed or used.
How should uncertainty be described?
General statistical principle: a confidence interval expresses a range of values compatible with the data and the assumptions of the analysis. A narrow interval indicates greater precision under those assumptions, while a wide interval indicates more uncertainty. A count or rate without an interval gives less information about precision. No confidence intervals for the complaint outcome are reported in the registry record. No p-values or inferential analysis results are reported either, so there is no basis for characterizing statistical significance.
The registry’s common-complaint threshold of at least 3% is a descriptive rule. It does not provide an uncertainty interval or show how stable the classification would be in another group of users. General statistical principle: when estimates are near a cutoff, uncertainty can affect whether a category appears to cross that threshold. Without the category counts, denominator, and uncertainty estimates, no such assessment can be made for this study.
What do the planning calculations mean?
The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It is a planning illustration based on the observed effect, not a description of this study’s design. This study is single-group and does not provide a like-for-like comparison between two arms. Such an illustration should not be interpreted as the trial’s sample-size justification or as observed power. The trial’s own sample-size justification is not reported in the registry record.
General statistical principle: power is a design-stage probability calculated under specified assumptions about the effect, variability, analysis, and sample size. It is not a measure of whether a completed study has demonstrated an effect. A post hoc calculation based on an observed effect does not replace an analysis of the actual data or quantify the precision of the reported outcome. No observed complaint effect or analysis result is reported in the registry record, so no trial-specific power interpretation can be made.
Finally, statistical methods must align with the question and the structure of the data. This study’s stated purpose centers on complaints and patient preferences, while its design has no comparator. Descriptive counts, rates, and preference summaries could address those experience questions if the data and denominators were reported. The registry lists 0 statistical analyses, so the methods actually used to summarize or analyze these outcomes are not reported in the registry record. General discussion of count models, uncertainty, or power does not imply that any of those methods was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 36 outcome measures and identifies several preference assessments: overall preference, learning to use the pen, attaching a new needle, setting the dose, injecting a dose, force on the plunger needed to inject a dose, assurance that drug is delivered, and removing a used needle. It does not report results for these preference outcomes in the registry record. The remaining outcome details and the role of each measure in the analysis are not reported in the registry record.
When a study assesses many outcomes, the chance of at least one apparently notable result can increase if each is tested separately. General statistical principle: multiplicity can be addressed through prespecified outcome hierarchies, adjusted testing procedures, or by treating the results as exploratory and emphasizing estimates with uncertainty. The registry lists 0 statistical analyses and does not report a multiplicity strategy, so it is not possible to determine whether any adjustment or hierarchy was planned or used.
Missing-data handling is also not reported in the registry record. The primary population includes participants who received at least one injection, but the number who met that definition is not reported. The registry does not report how many participants completed the 8-week assessment, whether complaint data were missing, or how missing observations were treated. The analysis population for the preference assessments is not reported in the registry record either.
These gaps limit interpretation of both outcome completeness and uncertainty. They do not establish that data were missing or that multiplicity affected the findings; they mean the registry record does not provide the information needed to evaluate those possibilities.
11. What the Result Does, and Does Not, Mean
The study addresses a practical question: what complaints and preferences were reported by participants using the Forteo B Pen to self-administer teriparatide in a community setting? Its primary outcome is defined as the number of complaints at 8 weeks, with functional and nonfunctional complaint categories. Its secondary outcomes cover overall preference and several steps involved in using the pen.
The registry record does not report the observed complaint count, category-specific results, or preference findings. It therefore cannot establish which complaints occurred most often, whether any complaint met the stated common-complaint criterion, or how participants rated the device. It also cannot show how precise any estimate was, because outcome counts, denominators, and confidence intervals are not reported in the registry record.
The single-group, non-randomized design is suited to collecting descriptions of users’ experience, but it does not support a like-for-like comparison with another device or treatment group. The study’s stated purpose includes informing user materials and assessing acceptability for commercial launch; that purpose should not be mistaken for a demonstrated conclusion about acceptability. The record describes the questions the study was designed to address, not the results needed to answer them quantitatively.
The adverse-event entries list 14 participants affected by serious adverse events and 134 affected by other adverse events, with no numbers at risk reported in the registry record. These entries are separate from the primary complaint outcome and do not permit rates or comparative safety conclusions. Overall, the registry information describes the design and outcome framework but does not report enough results to quantify complaints, preferences, or their uncertainty.
12. Why This Trial Matters Statistically
This study is statistically distinctive because its central aim is to describe patients’ experience with a self-administration device, rather than to estimate a treatment contrast between randomized groups. The primary outcome is a complaint count, and the listed secondary outcomes concern preferences across device-use tasks. For this kind of question, clear definitions, a transparent denominator, and complete descriptive reporting are central to interpretation.
The record makes the endpoint’s broad purpose visible, including the distinction between functional complaints related to malfunction and nonfunctional complaints related to cosmetic or perception concerns. It also sets a threshold of at least 3% for common complaints. But the complaint results themselves are not reported in the registry record. This contrast illustrates an important statistical point: defining an outcome and a reporting threshold does not reveal the observed frequency or its precision.
The design also constrains what can be learned. With a single group and no like-for-like control comparison, the study can be understood as an experience assessment, not as a comparative evaluation. The listed planning assumptions involving equal allocation between two arms are not the design of this study and should not be treated as its sample-size rationale or as evidence of observed power.
Finally, the record lists 36 outcome measures but 0 statistical analyses. Without results, analysis details, missing-data information, or uncertainty estimates, readers cannot evaluate the stability of complaint or preference summaries. The study matters statistically as an example of why outcome definitions and design descriptions must be distinguished from reported findings: a carefully framed question is not a substitute for the data needed to answer it.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is that the registry record does not report the primary complaint count or the complaint-category results. The number of participants who received at least one injection, and therefore met the stated primary outcome population definition, is not reported in the registry record. Although enrollment is listed as 200, the record does not establish how many contributed to the 8-week assessment.
The complaint rate denominator and the method for handling multiple complaints from the same participant are not reported in the registry record. Details of complaint ascertainment, the completeness of follow-up, and the handling of missing observations are also not reported. Without these details, readers cannot assess the reliability or precision of the complaint summaries.
The study is non-randomized, unmasked, and single-group. It therefore has no comparator for a like-for-like assessment, and reports of experience cannot be interpreted as comparative effects. The registry does not report the statistical analysis plan or any statistical analyses. It also does not report whether outcome definitions, preference measures, or multiplicity procedures were prespecified in the protocol.
The registry lists adverse-event counts but does not report the corresponding numbers at risk. This prevents calculation of event rates from the stated information. These are limitations of what is reported in the registry record; they do not establish that data collection or analyses were inadequate.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Study of the Experience of Patients With Osteoporosis Using the Forteo B Pen to Self Administer Once Daily Teriparatide Therapy — NCT00577863.
- Registry record last updated 2009-07-22; status last verified 2009-07.
- Results first posted 2009-06-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NCT00577863 is a completed phase 3, non-randomized, unmasked, single-group study sponsored by Eli Lilly and Company. It concerns patients with osteoporosis using teriparatide with the Forteo B Pen in a community setting. The registry lists enrollment of 200, a study start of 2008-01, and primary completion in 2008-05.
The primary outcome is the number of complaints at 8 weeks among participants who received at least one injection. Functional and nonfunctional complaints are distinguished, and common complaints are defined using a threshold of at least 3% complaint rate. Secondary outcomes include preference assessments related to the overall device experience and specific use tasks.
The registry lists 36 outcome measures and 0 statistical analyses. The observed primary outcome, preference results, analysis methods, and sample-size justification are not reported in the registry record. The design supports an experience-focused description, not a like-for-like control comparison.