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 Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly (NCT01410799), a na phase 2 study. The primary outcome is Muscle Strength.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01410799 |
| Phase | Phase 2 |
| Condition | Hormone Deficiency, Aging |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
The planned participants were healthy men and women aged 65 and older. The registry lists 13 enrolled participants and the conditions Hormone Deficiency and Aging. It does not report further eligibility details or describe the characteristics of the enrolled participants.
Intervention
The intervention was growth hormone releasing hormone (GHRH), described as a drug. The brief summary describes four nightly doses for 12 weeks. Dose amounts and other administration details are not reported in the registry record.
Comparator
No comparator group is listed. The study is classified as a single-group study, and allocation is listed as not applicable. It therefore does not provide a like-for-like control comparison.
Primary question
The primary outcome was muscle strength, assessed with pre-drug and post-drug one-repetition maximum testing over 12 weeks. The registry record states that the study was terminated and no data were collected, so it cannot answer whether muscle strength changed during treatment.
The broader research aim described in the registry was to evaluate GHRH in relation to muscle, bone, and fat tissues, as well as physical performance and the body's use of sugar. The listed secondary outcomes include glucose homeostasis, fat-free and lean mass, fuel utilization, physical performance, and tolerability of nocturnal administration. These aims describe what the study intended to investigate, not observed effects. The record does not report outcome estimates, participant-level measurements, or analyses that would establish whether any of these outcomes changed.
3. Trial Design
This was a phase 2, single-group study sponsored by the University of Pennsylvania. The registry lists 13 participants as enrolled. Allocation is recorded as not applicable, and masking is listed as none. With no comparator group, the design was not a randomized or controlled comparison. The study status is terminated. Its start is recorded as 2011-05 and its primary completion as 2011-06; those registry dates do not establish that participants completed the planned treatment or assessments.
The intervention was GHRH. The brief summary describes four doses nightly for 12 weeks, while the primary outcome timeframe is also listed as 12 weeks. Specific dose amounts, the schedule of outcome visits, and other treatment details are not reported in the registry record. The intended population was healthy men and women aged 65 and older. Further eligibility criteria and details about the participants actually enrolled are not reported.
The primary outcome was muscle strength, described as pre-drug and post-drug one-repetition maximum testing. The secondary outcomes named in the record concern glucose homeostasis, fat-free and lean mass, fuel utilization, physical performance, and tolerability of nocturnal administration. The record lists 6 outcome measures but 0 analyses. It states that the study was terminated and no data were collected for the primary outcome. Outcome results and explanations for termination are not reported in the registry record.
This design could have described changes within participants if measurements had been collected. Without a comparator, any change would also have been difficult to separate from other influences over time. In this case, the more immediate constraint is that the record reports no collected primary outcome data, so neither within-group change nor a comparison with another treatment can be estimated.
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 | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| STARTED | 13 |
| COMPLETED | 0 |
| NOT COMPLETED | 13 |
Reasons for not completing this period:
| Reason | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| PI decision | 13 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated, no data collected.
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 | Growth Hormone Releasing Hormone (GHRH) |
|---|---|---|
| Participants analysed | 13 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 13 |
| Sex/Gender, Customized: Male or Female | Participants | NA |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Muscle Strength, measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was muscle strength, assessed with pre-drug and post-drug one-repetition maximum testing. One-repetition maximum testing is a general method for quantifying the greatest load a person can lift once under the test conditions. As a measure of strength, it can provide a direct performance outcome rather than relying only on a participant's impression of change. The registry does not specify the exercise or exercises used, testing procedures, outcome units, or how multiple test results would be combined.
In general, measuring the same outcome before and after treatment can describe change over time within participants. Such a comparison does not by itself show that treatment caused a change, because other factors may also differ over time. A control group and an appropriate analysis can help assess those alternatives, but this study is listed as single-group with no comparator.
The primary outcome timeframe is listed as 12 weeks. However, the registry record states that the study was terminated and no data were collected. No baseline or follow-up strength measurements, change estimate, measure of uncertainty, or test of statistical significance is reported. The intended endpoint therefore has no result in the registry record to interpret.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical finding is the absence of an estimable primary outcome, rather than evidence for or against a change in strength. The registry explicitly states that the study was terminated and no primary outcome data were collected. It reports no muscle-strength estimate, confidence interval, or statistical test. Accordingly, the record cannot quantify the size or precision of a treatment-associated change in one-repetition maximum.
The listed enrollment is 13, but that number does not represent an analyzable sample for the primary outcome when the record states that no data were collected. Enrollment alone cannot supply an effect estimate or indicate how much uncertainty a hypothetical result would have had. Nor does the record establish how many people received treatment, completed the intended treatment period, or were assessed at any follow-up. Those details are not reported in the registry record.
The single-group design would have limited causal interpretation even if before-and-after measurements had been recorded. In general, a change observed over time in one group can reflect treatment, natural variation, changes in behavior, measurement variability, or other events. A comparator group can help distinguish treatment-associated change from changes that might occur without the intervention. Here, there is no comparator, and the absence of outcome data prevents even a descriptive estimate of within-group change.
The registry names several intended secondary outcomes, but no results or analyses are reported for them. The record lists 6 outcome measures and 0 analyses. These entries indicate the scope of planned measurement in the registry, not evidence that measurements were completed. The reason for termination, the extent of any data collection beyond the primary endpoint, and any analysis plan are not reported in the registry record.
There are no posted estimates from which to assess statistical precision. A confidence interval is a general way to express the range of values reasonably compatible with an estimate under a specified statistical model. Without an observed estimate and its underlying data, there is no interval to interpret. Likewise, the absence of a reported p-value is not evidence that an effect was absent or that a test was nonsignificant; it means the registry does not report an analysis that answers that question.
The adverse-event entries are separate from evidence about efficacy. The record lists no serious adverse events among 13 participants at risk and one participant affected by an other adverse event among 13 at risk. These descriptive counts do not establish that GHRH caused or did not cause an event, and the limited recorded information cannot characterize event types beyond what the registry lists. Overall, the record documents a terminated study with an intended clinical question but no reported outcome analysis capable of answering it.
9. Statistical Methods Explained
The registry identifies a single-group study with no masking and allocation listed as not applicable. These design features determine what kinds of statistical conclusions would be available if measurements had been collected. In a single-group study, outcomes can be described within the treated group, but there is no concurrent control group to represent what might have happened over the same period without the intervention. Lack of masking can also matter in general when measurements or assessments may be influenced by expectations, although the registry does not describe the assessment procedures in enough detail to judge that issue for this study.
What can a pre-treatment and post-treatment comparison show?
General statistical context: a paired analysis compares each participant's post-treatment measurement with that same participant's pre-treatment measurement. Pairing can account for stable differences between participants because the comparison is made within individuals. It still does not establish that treatment caused any observed change. Time trends, changes in activity or health, measurement conditions, and chance variation can also contribute. The registry describes pre-drug and post-drug one-repetition maximum testing, but reports no measurements or paired analysis. The analysis method that would have been used is not reported in the registry record.
For a numeric outcome such as a strength measurement, an analysis might report an average change or another summary of the change, together with a measure of uncertainty. The choice between an average and a different summary depends on the distribution of the data and the analysis plan. General statistical context: an estimate describes the observed magnitude in the analyzed participants; a confidence interval describes uncertainty around that estimate under the chosen model. Neither is available for the primary endpoint in this record.
Why does a comparator matter?
General statistical context: a controlled comparison estimates how outcomes differ between groups, rather than relying only on a before-and-after change in one group. Random allocation, when used, can make groups more comparable on average at the outset, though it does not guarantee identical groups. This study is not listed as randomized and has no comparator. It therefore cannot estimate a treatment-versus-control contrast. Even if pre-treatment and post-treatment measurements had been collected, changes could not be attributed to GHRH on the basis of that comparison alone.
A single-group design may still be useful for describing feasibility, measurement procedures, or changes observed among participants, depending on the data collected and the analysis. In this record, no primary outcome data were collected, so these descriptive uses cannot be assessed for muscle strength. The record does not report whether any other measurements were collected before termination.
What does the record say about statistical analyses?
The record lists 0 analyses and gives no primary outcome estimate, standard error, confidence interval, or p-value. A p-value, in general, summarizes how incompatible observed data are with a specified null model, subject to the assumptions of the test. It does not measure the probability that a hypothesis is true or establish clinical importance. Here, no reported test result is available to explain in those terms. The statistical analysis plan, including model choice, covariate adjustment, handling of repeated measurements, and criteria for interpreting results, is not reported in the registry record.
General statistical context: model assumptions matter because a statistical procedure is reliable only to the extent that its assumptions fit the data and design. For example, count outcomes can show over-dispersion when their variability exceeds what a simple count model expects; a model that accounts for that extra variability may produce more appropriate uncertainty estimates. That concept is not a finding about this study. The registry does not report outcome data or analysis methods from which to assess distributions, model fit, or over-dispersion.
How should planning calculations be read?
General statistical context: sample-size calculations estimate how many participants might be needed under specified assumptions about the effect to detect, variability, significance level, power, allocation, and analysis. They are planning illustrations, not observed power and not evidence that a study achieved a particular probability of detecting an effect. Any calculation based on an assumed fraction of an effect depends on that assumption and on the statistical model used. The registry record does not report the trial's own sample-size justification or its statistical plan.
The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect defined as a stated fraction of an observed effect. Those assumptions describe a hypothetical two-arm planning exercise, not the actual single-group design. No observed primary outcome effect is available in the registry record, so such an illustration cannot be treated as a study-derived estimate of the effect of GHRH. A planning illustration is also distinct from this study's enrollment of 13; the latter is the listed enrollment, not a demonstration that a particular power target was met.
General statistical context: precision generally improves with more informative data, but it also depends on variability, measurement quality, design, and analysis. No amount of discussion of hypothetical sample size can substitute for collected outcomes. Because this record reports no primary endpoint data and no analyses, the effect size, its precision, and the assumptions needed to analyze it remain unavailable.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 6 outcome measures, including muscle strength as the primary outcome and secondary outcomes concerning glucose homeostasis, fat-free and lean mass, fuel utilization, physical performance, and tolerability of nocturnal administration. It reports 0 analyses. No results are posted for the primary or secondary outcomes, so there are no outcome-specific estimates or tests to compare.
Multiplicity refers, in general, to the increased chance of obtaining at least one apparently notable result when many outcomes or statistical tests are examined. A statistical plan may address this by identifying a primary endpoint in advance, adjusting for multiple testing, or distinguishing confirmatory from exploratory analyses. The registry names a primary outcome, but the approach to multiple outcomes or tests is not reported in the registry record. It would be inappropriate to infer that any particular adjustment was planned or used.
The record states that no data were collected for the primary outcome and lists no analyses. It does not explain whether any secondary-outcome data were collected before termination. Participant flow, exclusions, the number assessed for each outcome, and the analysis populations are not reported in the registry record. Missing-data procedures and the handling of incomplete measurements are also not reported. Since no primary outcome data are reported, there is no basis for assessing whether missingness could have affected an estimate. These gaps limit interpretation independently of the absence of a comparator.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Growth Hormone Releasing Hormone (GHRH) | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Growth Hormone Releasing Hormone (GHRH) | 0 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Growth Hormone Releasing Hormone (GHRH) | 1 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Growth Hormone Releasing Hormone (GHRH) |
|---|---|---|
| Fatigue | Endocrine disorders | 1 of 13 |
The registry lists 13 participants at risk for serious adverse events in the GHRH group and 0 participants affected by serious adverse events. It also lists 13 at risk for other adverse events and 1 participant affected by an other adverse event. The recorded number of deaths is 0, and no top serious-event terms are listed.
These are descriptive registry counts. They do not establish whether an event was caused by GHRH, and the record does not report event descriptions, timing, severity details beyond the serious-versus-other classification, or follow-up duration for safety collection. The listed at-risk counts should not be read as proof that all enrolled participants received treatment or completed the intended 12 weeks, because those details are not reported.
General statistical context: when few participants are observed, a count of zero serious events does not show that the underlying risk is zero. The information is too limited to quantify safety precisely. These entries also do not compensate for the lack of collected primary outcome data or provide evidence about treatment effects.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase 2 study intended to evaluate GHRH in older adults, with muscle strength as the primary outcome and several additional outcomes of interest. It records 13 enrolled participants, a single-group design, no masking, and a terminated status. Most importantly for interpretation, it states that no primary outcome data were collected. As a result, the record provides no estimate of change in muscle strength and no statistical analysis of that outcome.
This does not mean that muscle strength was unchanged, that GHRH had no effect, or that an effect was present. Each of those conclusions would require outcome data. The record also does not establish why the study was terminated. The reasons for termination, any treatment exposure actually received, and the status of data collection for secondary outcomes are not reported in the registry record.
The intended before-and-after design could have described changes in participants over time, but a single-group study does not directly distinguish a treatment-associated change from other influences. A comparator would be needed for a treatment contrast, and this study has none. In this case, no primary measurements are available even for a within-group description.
The adverse-event counts should be read narrowly as registry entries: 0 serious adverse events among 13 at risk, 1 participant with an other adverse event among 13 at risk, and 0 deaths. They are not a complete characterization of safety, do not establish causation, and do not imply that the treatment is safe or unsafe. Likewise, the trial's enrollment is not a result and does not establish that the study had adequate statistical power.
The defensible conclusion is limited: the registry describes the study's aims and design, but it does not report collected primary outcome data or analyses that answer the clinical question. Claims about efficacy, lack of efficacy, statistical significance, or the magnitude and precision of a change are unsupported by the reported record.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a registered research question and evidence capable of answering that question. The registry records an intended intervention, population, primary endpoint, and secondary outcomes. It also records that the study was terminated and that no data were collected for the primary endpoint. Those details define a boundary on what can be inferred: a planned measurement is not an observed result.
The record also makes design constraints visible. A single-group study can, in principle, describe change within participants, but without a comparator it cannot estimate a treatment-versus-control difference. In this case, the missing primary measurements prevent even a descriptive estimate of within-group change. Statistical methods cannot recover an effect estimate when the underlying outcome data are absent.
The listed enrollment and adverse-event counts illustrate why denominators and outcomes must be kept distinct. Enrollment indicates the number recorded as enrolled, while the adverse-event entries describe participants listed as at risk and affected. Neither provides a strength outcome or a causal comparison. Similarly, sample-size planning illustrations are hypothetical calculations, not observed power or evidence that a study detected or failed to detect an effect.
For researchers, the record underscores the value of clear reporting of study status, outcome collection, analysis methods, and reasons for termination. The registry does state that no primary outcome data were collected and lists no analyses, but other details—including the analysis plan, data collection for secondary outcomes, and termination reason—are not reported. Statistical interpretation must track those distinctions rather than treating study aims as findings.
14. 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 consequential limitation is that the registry states no primary outcome data were collected. There is therefore no reported muscle-strength estimate, uncertainty interval, or analysis. The reason for termination is not reported in the registry record, so the circumstances behind the lack of data cannot be assessed.
The study is listed as single-group, with no masking and no comparator. Even with outcome data, this design would not provide a randomized treatment-versus-control contrast. The record also does not report whether participants received the planned regimen, how many completed it, or whether any follow-up assessments occurred. The planned schedule described in the brief summary should not be interpreted as evidence of actual treatment exposure or completion.
The registry does not describe the one-repetition maximum testing procedure, its units, the number of tests, or the planned statistical method. It does not report an analysis plan, a sample-size justification for the trial, methods for handling missing data, or analysis populations. The record lists 6 outcome measures and 0 analyses, but does not explain whether secondary measurements were collected before termination. These omissions prevent assessment of endpoint measurement, multiplicity, or selective availability of results.
The listed adverse-event counts are limited descriptive information. Event details, collection duration, and causal assessments are not reported. The record's 13 enrolled participants should not be treated as the denominator for every outcome or as proof of completed treatment. Taken together, these limitations mean that neither treatment effects nor the precision of possible effects can be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly — NCT01410799.
- Registry record last updated 2019-05-24; status last verified 2019-05.
- Results first posted 2019-05-24.
- 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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18. Record Summary
The registry describes a phase 2, single-group study of GHRH in healthy men and women aged 65 and older. It lists 13 enrolled participants, no masking, no comparator, and a terminated status. The planned intervention is described as four nightly doses for 12 weeks. Muscle strength, assessed with pre-drug and post-drug one-repetition maximum testing, was the primary outcome.
The registry states that the study was terminated and no data were collected for the primary outcome. It lists 6 outcome measures and 0 analyses, with no reported efficacy estimates. Safety entries list 0 serious adverse events among 13 at risk, 1 participant affected by an other adverse event among 13 at risk, and 0 deaths. The reason for termination, analysis plan, and extent of secondary-outcome data collection are not reported in the registry record.