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 The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries (NCT03812991), a randomized phase 4 study. The primary outcome is Visual Analogue Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03812991 |
| Phase | Phase 4 |
| Condition | Pelvic Ring Fractures |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 21 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Missouri-Columbia |
| Results posted | Yes |
2. Clinical Question
Population
Participants with pelvic ring fractures in the geriatric population. The primary outcome analysis included only participants who completed the study. The registry record does not report a specific age threshold or further eligibility details.
Intervention
Miacalcin calcitonin salmon nasal spray, described as one spray (200 IU) daily, with nostrils alternated each day.
Comparator
A non-treatment group, for which the arm description says no intervention was to be administered. Further care common to both groups is not described in the registry record.
Primary question
The trial set out to compare acute pain between the intranasal calcitonin and non-treatment groups, using a Visual Analogue Scale from 0 to 10. The scale labels 0 as no pain and 10 as the worst pain imaginable. Assessment was described as occurring up to three months post-injury. The registry record does not report a single comparison with numerical results, so the size and precision of any between-group difference cannot be characterized.
The rationale described in the registry concerns pain as a barrier to mobilization after pelvic ring injuries in older adults. It also describes early mobilization as a treatment tenet for osteoporotic fractures and notes that calcitonin has been studied for pain in other fracture settings. Those background statements explain the question motivating this trial; they are not results from this pelvic-fracture study.
The clinical question is therefore narrowly about the recorded acute-pain measure in the two randomized groups. The record does not state a primary contrast at a particular assessment time, beyond the broad timeframe of up to three months post-injury. It also does not report an estimate of the difference, its uncertainty, or a test of the comparison. The question can be identified, but its answer cannot be determined from the posted results described in the registry record.
3. Trial Design
This was a Phase 4 randomized, triple-masked, parallel-group trial sponsored by the University of Missouri-Columbia. The registry record lists an enrollment of 21 and a completed status. The recorded study start was 2019-07-01, and primary completion was 2022-09-30. These dates describe the trial record and do not provide information about how long each participant was followed.
The two arms were a non-treatment group and a group assigned Miacalcin Calcitonin Salmon Nasal Spray. The intervention description specifies one spray (200 IU) each day, alternating nostrils daily. The control description states that no intervention was to be administered. The record does not describe other care, the allocation ratio actually used, or the method used to generate or conceal the allocation sequence.
Randomization is intended, in general, to make treatment groups comparable at the start of a trial by assigning participants through a chance-based process. A parallel-group design assigns participants to one group for comparison with another rather than describing a crossover between interventions. Masking generally means that some people involved in the trial are not told which assignment was made; the record labels masking as triple but does not identify which roles were masked or how masking was maintained.
The primary outcome was a Visual Analogue Scale pain measure. Secondary outcomes listed in the registry were the Iowa Pelvic Score, SF-36 Short Form Health Survey, Timed Get Up and Go, and radiographic healing using intranasal salmon calcitonin. The record lists five outcome measures in total, but it does not provide numerical findings for these outcomes. It also does not describe the detailed visit schedule, the assessment timing for each secondary measure, or the analysis methods used for them.
Although the primary outcome description gives a broad timeframe of up to three months post-injury, the registry does not identify one assessment occasion for a single primary comparison. A protocol, detailed eligibility criteria, the intended allocation ratio, and a sample-size justification are not reported in the registry record. The listed enrollment should therefore be read as the number recorded for the trial, not as evidence about the adequacy of its planned 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.
Overall Study
| Stage | Non-Treatment Group | Miacalcin Calcitonin Salmon Nasal Spray |
|---|---|---|
| STARTED | 11 | 10 |
| COMPLETED | 8 | 9 |
| NOT COMPLETED | 3 | 1 |
Reasons for not completing this period:
| Reason | Non-Treatment Group | Miacalcin Calcitonin Salmon Nasal Spray |
|---|---|---|
| Lost to Follow-up | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Only participants who completed the study are included in the analysis of the data.
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.
Population: Only participants who completed the study are included in the analysis of the data.
| Characteristic | Unit | Non-Treatment Group | Miacalcin Calcitonin Salmon Nasal Spray | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 9 | 17 | |
| Age, Continuous | Years | 81 (65 to 95) | 81 (65 to 93) | 81 (65 to 95) |
| Sex: Female, Male: Female | Participants | 6 | 6 | 12 |
| Sex: Female, Male: Male | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 8 | 9 | 17 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 8 | 9 | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Analogue Scale, measured over The subject will be enrolled/assessed up to three months post-injury..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is acute pain measured with a Visual Analogue Scale. Its stated range is 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable. The registry lists the outcome unit as units on a scale and describes the summary parameter as a mean with standard deviation. The primary outcome population is limited to participants who completed the study.
A pain scale turns a participant’s assessment into a numeric measure that can be summarized across a group. In general, a mean describes the group’s average recorded score, while a standard deviation describes the spread of individual scores around that average. These summaries can help describe both the typical score and how varied the scores were, but they do not by themselves show the between-group effect or its precision. A comparison requires the relevant group values and a defined assessment time.
The registry describes the purpose as comparing acute pain and gives a timeframe of up to three months post-injury. It does not identify a single time point for a primary contrast or report the group means and standard deviations. The record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the endpoint’s measurement scale and intended summary are identifiable, but a particular numerical treatment contrast is not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial question, design, primary pain measure, and two treatment groups, but does not report numerical primary outcome results. In particular, it does not give group-level Visual Analogue Scale means or standard deviations, a between-group estimate, a confidence interval, or a p-value. Without those quantities, the direction, magnitude, and precision of the observed pain comparison cannot be described from the record.
The record lists an enrollment of 21 and says that only participants who completed the study were included in the primary outcome analysis. Enrollment alone does not establish how many participants contributed data to each group or at each assessment. Group-specific completion counts and the amount of missing outcome data are not reported in the registry record. It is therefore not possible to determine the analyzed sample sizes or assess whether missing observations could have affected the comparison.
The primary outcome is described as a mean of a 0-to-10 pain scale, but the record notes that it has several categories or time points and was not reduced to one comparison. A broad timeframe of up to three months post-injury is stated, without a single assessment occasion for the primary contrast. Multiple assessments can produce different answers depending on which time point or summary is selected. The registry does not report which specific contrast, if any, was used for a final statistical analysis.
Confidence intervals, when reported, express the statistical uncertainty around an estimated effect under the analysis assumptions. A narrow interval generally indicates greater precision than a wide interval, but neither width nor location can be assessed without an estimate and interval limits. A p-value addresses compatibility between data and a specified null model under specified assumptions; it does not measure the size or clinical importance of an effect. No such inferential results are reported for the primary comparison in this record.
The registry lists secondary measures covering pelvic function, health status, mobility, and radiographic healing. It does not provide their numerical results or the analyses used to evaluate them. The adverse-event entries list zero participants at risk and zero affected participants in both groups, as well as zero deaths. Because the listed at-risk counts are zero, these entries do not provide an evaluable denominator for estimating adverse-event occurrence, and they should not be interpreted as demonstrating that no events occurred among trial participants.
The trial is marked completed, but completion status is not itself evidence for or against an effect. The registry record also does not report a sponsor analysis that can be compared with an unadjusted recalculation. In the absence of a posted outcome estimate and its uncertainty, the appropriate statistical reading is that the trial’s reported results are insufficient to quantify the primary comparison. No claim about whether the intervention changes pain can be made from these registry entries alone.
9. Statistical Methods Explained
The design and outcome descriptions identify some elements needed to understand a trial analysis, while leaving other elements unspecified. The sections below explain the statistical concepts relevant to those recorded features and distinguish general principles from details of this study.
What does randomization contribute?
In general, random assignment is used to reduce systematic differences between groups at the point of assignment. It does not guarantee that the groups will be identical, particularly in a small trial, and it does not replace the need to describe baseline characteristics and analyze outcomes appropriately. The registry labels this study randomized, but the sequence-generation method, allocation concealment method, and group allocation ratio are not reported in the registry record.
The trial is described as parallel group. In general, a parallel design compares outcomes among participants assigned to separate groups. Interpretation depends on knowing how outcomes were measured, when they were measured, and which participants contributed to each analysis. The registry identifies the arms and the primary outcome timeframe but does not supply a complete assessment schedule or analysis population details beyond stating that study completers were included for the primary outcome.
How should the primary measure be read?
The primary endpoint is a continuous pain score summarized as a mean and standard deviation. In general, a mean is the arithmetic average of observed scores; the standard deviation describes how dispersed those scores are around the mean. A standard deviation is not the uncertainty around the mean difference. To quantify uncertainty in a comparison, an analysis would ordinarily report an estimate and a confidence interval or another suitable uncertainty measure.
The scale is recorded as ranging from 0 to 10, with its endpoint meanings specified in the registry. A group mean compresses the individual responses into one summary, so it cannot show the full score distribution. The standard deviation adds information about spread but also cannot show every feature of that distribution. The record supplies no group means or standard deviations, and therefore no descriptive comparison can be reconstructed from the registry entries.
For an interpretable treatment comparison, the assessment occasion matters. A score measured at one point after injury may answer a different question from a score measured at another point. The registry gives a timeframe of up to three months post-injury and notes several categories or time points, but does not reduce the primary endpoint to a single comparison. The specific primary time point, any method of combining repeated observations, and any adjustment for baseline pain are not reported in the registry record.
What do masking and analysis choices mean?
The registry identifies the trial as triple-masked. In general, masking can limit the influence of treatment expectations on care, outcome assessment, or analysis. The meaning of a masking label depends on which trial roles were kept unaware of assignment. Those roles and the practical masking procedures are not described in the registry record, so the label cannot be expanded into more specific claims.
Statistical analysis choices determine how the observed data are translated into estimates. For example, an unadjusted comparison uses outcome summaries without covariate adjustment, while an adjusted model accounts for selected participant characteristics. The registry record does not identify a model, covariates, a primary contrast, or inferential procedures for the pain outcome. It would therefore be inappropriate to attribute a particular analysis method to this trial.
In general, a confidence interval is a range of values compatible with the observed data under a specified statistical procedure and its assumptions. It communicates uncertainty about an estimate, not the probability that a particular treatment effect is true. A p-value is also conditional on an analysis model and tests compatibility with a null hypothesis; it is not a measure of effect magnitude. No confidence interval or p-value for the primary pain comparison is reported in the registry record, so these concepts cannot be applied to a numerical trial result.
What do the planning assumptions describe?
The record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence that the trial was designed with those assumptions, and not an account of the trial’s own sample-size justification. The actual sample-size justification is not reported in the registry record.
In general, a sample-size calculation estimates how many participants would be needed under chosen assumptions to detect a specified effect with a specified statistical power. Such planning depends on the target effect, outcome variability, significance level, allocation, and analysis method. The registry record does not include numerical planning estimates or the values of the effect fractions in the available information. The planning assumptions therefore cannot be used to state a participant count needed for any particular effect. Sample-size planning figures, when available, are not observed power and do not establish what the completed trial was able to detect.
The registry’s planning description distinguishes total event counts for time-to-event outcomes from participants per arm for other outcomes. The primary endpoint in this trial is recorded as a continuous measure, so the relevant general planning unit is participants per arm. No numerical per-arm planning estimates are reported in the registry record. The listed enrollment of 21 should not be confused with a calculated planning target or with the number analyzed in each arm.
Why can over-dispersion matter?
In general, over-dispersion occurs when data vary more than a statistical model expects. A model that underestimates variability can produce confidence intervals that are too narrow and p-values that appear more conclusive than warranted. This concept is relevant to choosing and checking models for some types of outcome data, but the registry does not report a model or evidence of over-dispersion for this trial. The primary pain score is described as a continuous measure summarized by a mean and standard deviation; no claim about model fit can be made without the underlying data and analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The primary pain outcome is not presented as one reduced comparison. The registry explicitly notes several categories or time points, and it gives a broad assessment timeframe of up to three months post-injury. When an outcome is measured at multiple times or through several categories, the choice of contrast can affect interpretation. Testing multiple comparisons can also increase the chance of at least one apparently notable result by chance. In general, multiplicity procedures can address this issue, but the registry record does not report a multiplicity adjustment or a prespecified approach to selecting among times or categories.
The record lists the Visual Analogue Scale as the primary outcome and four secondary outcomes: the Iowa Pelvic Score, SF-36 Short Form Health Survey, Timed Get Up and Go, and radiographic healing using intranasal salmon calcitonin. It does not report a hierarchy of secondary analyses, a family of hypotheses, or a method for controlling error across outcomes. The number of outcome measures recorded does not by itself establish how many statistical tests were conducted.
For the primary pain analysis, the registry states that only participants who completed the study were included. This indicates a completer analysis population for that endpoint, but does not describe how completion was defined, how many participants completed, or how missing measurements were handled. The analysis population for the secondary outcomes is not reported in the registry record. Details such as imputation, exclusion rules, or sensitivity analyses are also not reported.
The record gives no analysis count and no numerical outcome analyses. It does not report interim analyses, and the existence or absence of an interim plan is not reported in the registry record. Without analysis details and results, it is not possible to assess how multiplicity or missingness affected the reported evidence.
11. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, triple-masked, parallel-group trial compared intranasal calcitonin with a non-treatment group in elderly pelvic ring injuries. It identifies acute pain on a 0-to-10 Visual Analogue Scale as the primary outcome and describes its summary as a mean with standard deviation. These details clarify the intended question and how the primary outcome was to be represented.
They do not establish the direction or size of a difference between groups. No group-specific pain summaries, effect estimate, confidence interval, or p-value are reported in the registry record. Without an estimate and uncertainty, the posted information does not show how much the groups differed, how precise such a difference was, or whether the observed data were compatible with a range of possible effects.
The enrollment of 21 is a record-level trial count, not a result. It does not reveal the analyzed number in each arm or the number contributing to each outcome assessment. Because the primary analysis included study completers, and completion counts are not reported, the available record also cannot establish how missing observations relate to the analysis.
The secondary outcomes broaden the planned assessment to pelvic function, health status, mobility, and radiographic healing, but numerical results for them are not reported. Similarly, the adverse-event entries have zero at-risk counts, so they do not provide an adequate basis for interpreting event frequency. Trial completion and a list of intended outcomes should not be mistaken for evidence about the outcomes themselves.
In general, a trial result is most informative when it includes a clearly defined comparison, the group data or effect estimate, an uncertainty measure, and enough information to understand who was analyzed and when. Those elements are not present for a single primary comparison in this registry record. The statistical meaning is therefore limited: the trial’s question and design are recorded, but the posted results do not permit a quantitative conclusion about the pain comparison.
12. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a registered question and an interpretable result. The record specifies randomization, masking, parallel groups, the intervention, a comparator, and a primary pain measure. Those details help identify what the investigators intended to compare. Yet an intended comparison and a completed trial status do not substitute for an effect estimate and its uncertainty.
The enrollment recorded as 21 makes careful attention to analyzed counts especially important. A total enrollment does not tell readers how many participants were assigned to each group, how many completed the study, or how many contributed an outcome at a given time. These details matter for understanding precision and the possible influence of missing data. They are not reported for the primary outcome analysis beyond the statement that only study completers were included.
The timeframe of up to three months post-injury, together with the note that the primary outcome has several categories or time points, also highlights the importance of a clearly specified primary contrast. When more than one assessment may be relevant, readers need to know which comparison is intended as primary and how other analyses are handled. That information is not reported in the registry record.
The record also separates the trial’s own design from planning illustrations based on an observed effect. Such illustrations are planning exercises, not evidence of observed power or proof that a trial was adequately sized. Without the numerical planning outputs and a reported sample-size justification, no conclusion about the trial’s design adequacy can be drawn from those assumptions.
These features matter because transparent reporting allows readers to judge not only what was asked, but also how strongly the posted data support an answer. In this record, the statistical methods and numerical findings are too incomplete to quantify the primary comparison. Recognizing that limit is a substantive interpretation, rather than treating missing results as a positive or negative finding.
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 main trial-specific limitation in the registry record is the absence of numerical outcome results for the primary pain measure. The record names the Visual Analogue Scale and its range, but does not report group means, standard deviations, a between-group estimate, or an uncertainty measure. As a result, neither the direction nor the precision of a primary comparison can be assessed.
The primary endpoint is described over a timeframe of up to three months post-injury, and the record notes several categories or time points without reducing them to one comparison. The specific occasion used for the primary analysis and the approach to any repeated assessments are not reported. This makes the intended primary contrast less fully specified than a single-time-point result would be.
The registry records enrollment of 21, while the primary analysis population is limited to participants who completed the study. It does not report completion counts by group, analyzed counts, or outcome-specific missingness. The effect of restricting the analysis to completers therefore cannot be evaluated. The eligibility criteria, baseline characteristics, and actual allocation ratio are also not reported in the registry record.
Although the study is labeled triple-masked, the roles masked and procedures for maintaining masking are not described. The statistical analysis plan, model, adjustment variables, handling of missing data, and multiplicity approach are not reported. The listed adverse-event group counts show zero participants at risk, which does not permit an assessment of event occurrence among participants.
Finally, the registry describes planning assumptions but does not report numerical planning estimates or a trial-specific sample-size justification. These gaps prevent a complete appraisal of the precision the study was intended to achieve. They do not establish that the trial failed or that the intervention had a particular effect; they limit what can be concluded from the recorded information.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries — NCT03812991.
- Registry record last updated 2024-06-11; status last verified 2024-06.
- Results first posted 2024-06-11.
- 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
The registry record describes a completed Phase 4 randomized, triple-masked, parallel-group trial sponsored by the University of Missouri-Columbia. It lists an enrollment of 21 and a comparison between a non-treatment group and Miacalcin Calcitonin Salmon Nasal Spray, given as one spray (200 IU) daily with nostrils alternated each day.
The primary outcome was acute pain measured on a Visual Analogue Scale from 0 to 10, with a timeframe of up to three months post-injury. Only participants who completed the study were included in the primary analysis. Secondary outcomes were the Iowa Pelvic Score, SF-36 Short Form Health Survey, Timed Get Up and Go, and radiographic healing using intranasal salmon calcitonin.
The registry does not report a single numerical primary comparison, group outcome summaries, or inferential results. It also does not report the detailed analysis plan, handling of missing data, or multiplicity procedures. The statistical record therefore identifies the trial’s question and design but does not permit a quantitative interpretation of its outcomes.