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 Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism (NCT02005250), a registered phase not stated study. The primary outcome is Thyroid Extreme CT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02005250 |
| Phase | Phase not stated |
| Condition | Hyperthyroidism, Hypothyroidism |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 93 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Steen Bonnema |
| Results posted | Yes |
2. Clinical Question
The registry describes an assessment of bone structure in women with newly diagnosed thyroid disorders. The central question is whether bone cortical thickness at the radius, measured before treatment and one year later, changes during treatment aimed at obtaining euthyroidism. The study includes separate groups with hyperthyroidism and hypothyroidism, rather than a randomized treatment group and a comparable control group.
Population
The arm descriptions identify pre- and postmenopausal women with newly diagnosed thyroid disorders: 61 with hyperthyroidism and 32 with hypothyroidism. The record does not give further eligibility criteria or details about the population included in the primary outcome analysis.
Intervention
Participants received treatment for their thyroid functional disorder, with the stated aim of obtaining euthyroidism. The registry does not describe specific treatments, doses, treatment changes, or how achievement of euthyroidism was determined.
Comparator
The assessment compares measurements taken before treatment with those taken one year later. The two disorder groups are not like-for-like controls: they have different thyroid conditions, and the allocation method is not stated. The registry does not describe a separate untreated or randomized control group.
Primary question
How does median bone cortical thickness in the radius, measured in millimeters by high-resolution peripheral quantitative CT, compare before treatment and one year after treatment aimed at obtaining euthyroidism? The registry record does not report the measurement values or a statistical estimate of change.
3. Trial Design
This completed study is registered as a study of bone structure and strength before and after treatment of hyperthyroidism or hypothyroidism. Its listed enrollment is 93. The registry gives an overall start date of 2012-02 and a primary completion date of 2016-10. It identifies one primary outcome measure and no registered analyses.
The arm descriptions refer to 61 pre- and postmenopausal women with hyperthyroidism and 32 pre- and postmenopausal women with hypothyroidism. These are groups defined by different thyroid conditions, not two treatment arms that can automatically be treated as interchangeable. The record states that the study is not a randomized comparison and that allocation is not stated. It therefore does not establish a like-for-like control comparison between the groups.
The study brief describes assessment of bone structure using Dexa-scan, extreme CT, and bone markers before treatment and one year afterward. The primary outcome specifically concerns radial cortical thickness measured by high-resolution peripheral quantitative CT. Treatment is described as being aimed at obtaining euthyroidism, but the treatment regimens and the methods used to establish thyroid status are not reported in the registry record.
The record does not describe a detailed protocol, recruitment procedures, masking, or the timing of assessments beyond the primary outcome's one-year timeframe. It also does not report numerical primary outcome results or analysis records. Accordingly, the registered design provides context for what was intended to be measured, but does not support an estimate of how bone thickness changed or whether any change differed between the thyroid disorder groups.
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 | Hyperthyroidism | Hypothyroidism |
|---|---|---|
| STARTED | 61 | 32 |
| COMPLETED | 46 | 27 |
| NOT COMPLETED | 15 | 5 |
Reasons for not completing this period:
| Reason | Hyperthyroidism | Hypothyroidism |
|---|---|---|
| Lost to Follow-up | 15 | 5 |
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 | Hyperthyroidism | Hypothyroidism | Total |
|---|---|---|---|---|
| Participants analysed | 46 | 27 | 73 | |
| Age, Continuous | years | 55.83 (SD 11.47) | 48.3 (SD 11.3) | 53 (SD 9) |
| Sex: Female, Male: Female | Participants | 46 | 27 | 73 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Denmark | Participants | 46 | 27 | 73 |
| Cortical thickness | mm | 0.74 (0.61 to 0.83) | 1.15 (1.01 to 1.24) | 0.90 (0.61 to 1.24) |
6. Primary Endpoint
The registry lists the primary outcome as Thyroid Extreme CT, measured over one year.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | mm |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is bone cortical thickness in the radius, measured in millimeters using high-resolution peripheral quantitative CT. The listed summary measure is the median, with the inter-quartile range as the measure of dispersion. The timeframe is one year, and the description specifies measurement before and after treatment aimed at obtaining euthyroidism in people with a newly diagnosed thyroid disorder.
In general, cortical thickness is a structural characteristic of bone. An imaging measure can describe bone structure directly, whereas a clinical event such as a fracture captures a different kind of outcome. The endpoint can therefore address whether a structural measurement changes over the stated observation period; by itself, it does not establish how that measurement relates to later clinical outcomes.
The median describes the middle of a distribution and is less influenced by extreme observations than the arithmetic mean. The inter-quartile range describes the spread of the middle portion of the observed values. In general, these summaries can be useful when data are skewed or contain outlying values. The registry record does not report the median, inter-quartile range, participant-level observations, or an estimated before-and-after change. The endpoint definition alone therefore does not show the direction, size, or precision of any change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically specific measurement: radial cortical thickness assessed by high-resolution peripheral quantitative CT before and one year after treatment aimed at obtaining euthyroidism. It also specifies that the outcome is summarized by a median and inter-quartile range. These details define what the investigators intended to measure, but they do not constitute a result.
Numerical values for the primary endpoint and an estimate of change are not reported in the registry record. No confidence interval, p-value, or other inferential result for that endpoint is reported in the registry record. The registry also lists no analysis records. Consequently, the posted registry information does not establish whether the median thickness increased, decreased, or remained similar, nor does it quantify how precisely any change was estimated.
The before-and-after framing matters for interpretation. Measurements on the same person at separate times can be related, and an analysis that accounts for that pairing may differ from an analysis that treats observations as independent. The registry record does not state how repeated measurements were analyzed. It also does not report whether all participants had measurements at both time points or how incomplete measurements were handled.
The two disorder groups should not be read as randomized comparison arms. They represent different thyroid conditions, and allocation is not stated. Any difference between them could reflect differences in the groups as well as differences in their observed bone measurements. The record does not describe an adjustment strategy or provide an analysis comparing the groups. A direct causal contrast between the disorder groups is therefore not established by the registered design information.
The adverse-event entries list no serious adverse events, other adverse events, or deaths in the safety groups described in the registry. Those entries are separate from the primary bone measurement and do not fill the gap in the efficacy outcome results. Their interpretation is also limited by the absence of a reported safety observation period and by the fact that the listed at-risk group sizes do not match the arm descriptions.
Overall, the record documents the measurement question, study groups, and some safety counts, but not the numerical primary outcome findings or the statistical analyses. Any interpretation of the treatment-associated bone changes would require results and methods that are not reported in the registry record.
9. Statistical Methods Explained
The registry specifies a median and inter-quartile range for the primary measure, but it does not describe the statistical methods used to analyze the measurements. The concepts below explain how such methods are generally interpreted; they should not be taken as a description of analyses performed in this study.
What does the median and inter-quartile range tell the reader?
In general, the median is the central observation after measurements are ordered. The inter-quartile range describes the span of the middle portion of those observations. Together, these summaries give information about the typical value and the distribution's spread without requiring that the data be symmetric. They do not, on their own, estimate a before-and-after difference or show the uncertainty around that difference.
For a repeated measurement, a useful descriptive presentation could show the distribution at each time point and the distribution of within-person changes. Those are different summaries: comparing two group medians is not necessarily equivalent to finding the median of each participant's change. The registry does not report which summaries, if any, were used beyond specifying the endpoint's median and inter-quartile range.
Why does the before-and-after structure matter?
In general, measurements taken from the same participant are likely to be related. A paired analysis accounts for the fact that each follow-up measurement belongs to a participant with a baseline measurement. An unpaired analysis instead treats the measurements as if they came from unrelated individuals. Those approaches answer different statistical questions and can give different estimates of uncertainty. The registry record does not report whether the analysis used paired methods, how it handled participants without measurements at both time points, or whether any model was fitted.
A before-and-after change is also not automatically attributable to treatment. In general, changes over time can reflect treatment, the natural course of a condition, other changes during follow-up, or measurement variability. A randomized control group can help distinguish treatment effects from other influences, but the registry describes no randomized comparison and does not state an allocation method. The two groups are defined by different thyroid disorders, so they are not a direct substitute for a shared control group.
What would precision and statistical significance mean?
In general, a confidence interval gives a range of estimates compatible with the data and the method used, and conveys uncertainty around an estimated effect. A p-value addresses how compatible the data are with a specified statistical null model; it does not describe the size or clinical importance of an effect. Neither an estimate nor a confidence interval or p-value for the primary outcome is reported in the registry record. The registered endpoint description cannot therefore be used to judge statistical significance or precision.
The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Its effect to detect is expressed as a stated fraction of the observed effect. Such calculations are planning illustrations based on an effect assumption, not evidence about the study's observed result and not observed power. The registry record does not report the trial's own sample-size justification or its design assumptions. The illustration's assumptions should not be mistaken for the analysis actually used in this study.
How should the group structure affect comparisons?
The hyperthyroidism and hypothyroidism groups differ by condition, and the record says the study is not a randomized comparison. In general, comparisons between groups that were not made comparable by random assignment can be affected by differences in participant characteristics, disease features, or treatment. Statistical adjustment can address measured factors under appropriate assumptions, but cannot guarantee removal of unmeasured differences. The registry record does not report an adjusted model, covariates, or a between-group hypothesis test.
Finally, one registered primary outcome does not reveal whether additional outcomes or analyses were planned elsewhere. The record lists one outcome measure and no analysis records, but does not report a complete statistical analysis plan. Thus the choice of tests, model assumptions, handling of multiplicity, and approach to missing observations are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, the primary measure of radial cortical thickness, and no analysis records. This does not establish that the study had no other analyses, exploratory outcomes, or planned comparisons. A full statistical analysis plan and any multiplicity procedure are not reported in the registry record.
In general, testing multiple outcomes or conducting multiple comparisons can increase the chance of obtaining an apparently notable result by chance. Methods to address multiplicity depend on what was planned and which results are intended to support confirmatory conclusions. Because the record does not describe the analysis plan or report inferential results, it is not possible to determine whether multiplicity was relevant or how it was handled.
The record also does not describe missing-data rates, reasons for missing measurements, imputation, or sensitivity analyses. For a before-and-after endpoint, incomplete follow-up can affect which participants contribute to a change estimate. Without information about observed measurements at each time point and the analysis population, the reader cannot tell how representative any analyzed group would be of the enrolled participants.
Definitions of analysis populations—such as which participants were included in the primary endpoint analysis—are not reported in the registry record. The enrollment figure and the arm descriptions do not by themselves identify the population used for an outcome analysis. Since no numerical primary results or analysis records are posted, conclusions about exclusions, missingness, or the effect of analysis choices cannot be drawn.
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 |
|---|---|---|---|
| Hyperthyroidism | 0 | 46 | 0.0% |
| Hypothyroidism | 0 | 27 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hyperthyroidism | 0 of 46 |
| Hypothyroidism | 0 of 27 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Hyperthyroidism | 0 of 46 |
| Hypothyroidism | 0 of 27 |
The registry's safety entries list the following counts. In the hyperthyroidism safety group, 46 people are listed as at risk for serious adverse events and 0 as affected; the other-adverse-event entry also lists 46 at risk and 0 affected, with 0 deaths. In the hypothyroidism safety group, 27 are listed as at risk for serious adverse events and 0 as affected; the other-adverse-event entry lists 27 at risk and 0 affected, with 0 deaths.
These are registry counts, not estimates of comparative risk. The record does not provide a safety observation timeframe, definitions of the adverse-event categories, or event-level detail. The safety group counts also differ from the arm descriptions, and the registry does not explain the relationship between those populations. The counts should therefore be read as reported entries rather than assumed to represent every participant described elsewhere in the record.
A recorded count of 0 means that no events are listed in that category for the stated safety group in the registry. It does not establish that the risk is absent or that all possible events were captured. These safety entries also do not provide evidence about the primary bone-thickness outcome.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to measure radial bone cortical thickness before and one year after treatment for newly diagnosed hyperthyroidism or hypothyroidism. It identifies the measurement method, unit, and summary approach, and describes two groups defined by thyroid condition. This is useful for understanding the study's intended question and the kind of structural outcome assessed.
It does not establish the direction or magnitude of a treatment-associated change. Numerical outcome values and statistical analyses are not reported in the registry record. There is no posted estimate of change or its precision to assess. Thus, the record cannot support a conclusion that cortical thickness increased, decreased, or was unchanged after treatment.
The design information also does not support treating the hyperthyroidism and hypothyroidism groups as randomized alternatives. They have different conditions, and allocation is not stated. Without a like-for-like control comparison and details of the analysis, differences between groups cannot be attributed to a treatment effect on the basis of this record.
Similarly, a structural measurement does not by itself establish a change in fractures, symptoms, or other clinical outcomes. The record's description concerns a bone imaging endpoint, not a reported clinical event outcome. The listed safety counts are limited registry entries and do not answer the primary bone-measurement question.
The appropriate reading is therefore descriptive: the registry documents a completed study and its intended measurement framework, while leaving the primary results and important analytic details unavailable. Claims about benefit, lack of benefit, or comparative treatment effects would go beyond what the registry record reports.
13. Why This Trial Matters Statistically
This study is statistically notable for the way it frames a repeated structural measurement in two distinct thyroid disorders. The endpoint is not a single post-treatment reading alone: the description specifies measurement before treatment and one year later. That distinction makes the handling of within-person measurements central to interpreting any estimated change.
The use of the median and inter-quartile range signals a descriptive focus on the distribution of thickness measurements. In general, these summaries can convey the center and spread of data without requiring a symmetric distribution. But they do not replace an estimate of change, its uncertainty, or a clear account of the analysis population. Those results are not reported in the registry record.
The study also illustrates why group labels matter. Hyperthyroidism and hypothyroidism define different clinical populations, not necessarily comparable arms. With allocation unstated and no randomized comparison described, a contrast between these groups would not automatically isolate a treatment effect. Understanding that design feature prevents over-reading a group comparison as a controlled causal result.
Finally, the record distinguishes the intended scientific question from the evidence available for evaluating it. It gives the endpoint and timeframe, but no numerical primary results or analysis records. The safety entries report zero affected in listed categories, yet do not supply the missing estimate of bone change. Keeping those information types separate is an important part of sound statistical interpretation.
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 important limitation of the registry record for interpreting this study is the absence of numerical primary outcome results. Although the endpoint and timeframe are specified, no median values, inter-quartile ranges, estimated changes, confidence intervals, or p-values are reported in the registry record. The lack of analysis records also prevents assessment of the methods used to estimate change.
The design description limits causal interpretation. The registry states that the study is not a randomized comparison and that allocation is not stated. The two groups have different thyroid disorders, so they do not function as like-for-like controls on the information recorded. The record does not describe a separate control group, adjustment strategy, or method for addressing differences between groups.
Further details needed to evaluate the endpoint are not reported in the registry record. These include the number of participants with measurements at both time points, missing-data handling, analysis-population definitions, and the statistical model or test. The record also does not give additional eligibility criteria, treatment regimens, or a detailed account of how euthyroidism was assessed.
The safety counts require caution because the listed at-risk group sizes differ from the arm descriptions, and the record does not explain the discrepancy or state a safety observation period. The entries therefore cannot be assumed to represent the same populations or follow-up basis as the primary outcome. These limitations concern the available registry information; they do not determine what may have been analyzed or reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism — NCT02005250.
- Registry record last updated 2020-04-13; status last verified 2020-04.
- Results first posted 2020-04-13.
- 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 identifies a completed study of bone structure before and after treatment for hyperthyroidism or hypothyroidism, with listed enrollment of 93. The arm descriptions specify pre- and postmenopausal women in each disorder group. The primary outcome is median radial cortical thickness in millimeters, measured by high-resolution peripheral quantitative CT before treatment and one year later. Treatment was aimed at obtaining euthyroidism.
The study is not described as a randomized comparison, and allocation is not stated. The two disorder groups are not like-for-like controls. The registry lists one outcome measure and no analysis records. Numerical primary outcome results, analysis methods, and details about missing data are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in each of the stated safety groups, with different at-risk counts for the two groups.