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 Long-Term Retention of Gadolinium in Bone (NCT01853163), a na na study. The primary outcome is Concentration of Total Gadolinium in Trabecular Bone.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01853163 |
| Phase | NA |
| Condition | Focus: Long-term Retention of Gadolinium-based Contrast Agent |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 92 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Navitas Life Sciences GmbH |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients who had received gadolinium-based contrast agents (GBCAs), including people with moderate or severe renal impairment and people with stable normal renal function at the time of GBCA injection. The brief summary describes prior exposure to a single dose or multiple doses of the same GBCA. The record also identifies a GBCA-naive control group. It does not report further eligibility details or the number of exposed participants in each renal-function category.
Intervention
This was not a treatment-assignment study. The listed intervention was gadolinium analysis in bone and tissue samples, a procedure for evaluating tissue concentrations. Participants in the exposure group had received GBCAs in the past; the registry does not describe a new study dose being assigned.
Comparator
The record includes a GBCA-naive control group, but the comparison was not randomized. These groups therefore should not be treated as exchangeable groups created by random allocation. The record does not provide enough detail to establish that they were alike in other relevant characteristics.
Primary question
The primary question was whether total gadolinium could be characterized in trabecular bone tissue from patients with a history of GBCA exposure. Concentration was to be measured by ICP-MS and summarized using a geometric mean and geometric coefficient of variation. The listed sampling point was Day 0 (visit 2, surgery), with an optional visit 6 (second surgery). A numerical primary endpoint result is not reported in the registry record, so the size and precision of any exposure-group concentration estimate cannot be assessed from this record.
3. Trial Design
The study is registered as an exploratory, single-group study of long-term gadolinium retention in bone. The registry lists the phase and allocation as NA, masking as none, and the model as single group. It is marked completed. Enrollment is listed as 92. The sponsor is Navitas Life Sciences GmbH.
The study objective was to prospectively explore the potential for long-term retention of gadolinium in bones among patients who had received either a single dose of a GBCA or multiple doses of the same GBCA. The brief summary distinguishes patients with moderate or severe renal impairment from those with stable normal renal function at the time of injection; normal renal function is described as eGFR greater than 60 ml/min/1.73 m2. The registry also identifies a GBCA-naive control group. This is an observational exposure comparison rather than a randomized comparison, and the record cautions that the arms are not a like-for-like control comparison.
The registry lists a study start date of 2013-05-06 and a primary completion date of 2018-12-05. It does not report a separate study completion date in the registry record for this description. The primary endpoint is total gadolinium concentration in trabecular bone, with samples associated with surgery. The stated timeframe is Day 0 (visit 2, surgery), with an optional visit 6 (second surgery). The listed procedure is gadolinium analysis in bone and tissue samples.
The registry names 21 outcome measures overall and lists secondary outcomes concerning total gadolinium in skin tissue and several elements in skin or bone tissue. It reports 0 analyses. The detailed protocol, recruitment flow, eligibility rules, and analysis populations are not reported in the registry record. The record also does not report a statistical analysis plan or a sample-size justification. These omissions limit interpretation of how the planned study procedures relate to the posted outcome information.
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: Study sample size was decreased on the basis of protocol amendment #2 date 26 FEB 2016.
Overall Study
| Stage | GBCA Exposure Group - Normal Renal Function. | GBCA Exposure Group - Impaired Renal Function. | GBCA Naive - Control Group With Normal Renal Function. | GBCA Naive - Control Group With Impaired Renal Function. |
|---|---|---|---|---|
| STARTED | 45 | 29 | 7 | 11 |
| COMPLETED | 45 | 29 | 7 | 11 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Note: Below values for both control groups (0 (0%)) are "NA = Descriptive statistics not performed since it does not satisfy 2/3 of GBCA concentration values are available and above BLQ", 2 patients of the control group with impaired renal function have values \> BLQ, max 1.921 ug/g.
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 | GBCA Exposure Group - Normal Renal Function. | GBCA Exposure Group - Impaired Renal Function. | GBCA Naive - Control Group With Normal Renal Function. | GBCA Naive - Control Group With Impaired Renal Function. | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 45 | 29 | 7 | 11 | 92 | |
| Age, Continuous | years | 64 (SD 10.5) | 74.6 (SD 7.37) | 70 (SD 10.88) | 78.4 (SD 5.28) | 69.5 (SD 10.65) |
| Sex: Female, Male: Female | Participants | 24 | 20 | 2 | 6 | 52 |
| Sex: Female, Male: Male | Participants | 21 | 9 | 5 | 5 | 40 |
| Race and Ethnicity Not Collected | Participants | — | — | — | — | 0 |
| Height | cm | 164.1 (SD 11.08) | 158.9 (SD 9.83) | 174 (SD 5.86) | 162.6 (SD 7.58) | 163 (SD 10.63) |
| Weight | kg | 76 (SD 21.09) | 66.7 (SD 19.01) | 90 (SD 13.08) | 76.6 (SD 14.86) | 74.2 (SD 20.03) |
6. Primary Endpoint
The registry lists the primary outcome as Concentration of Total Gadolinium in Trabecular Bone, measured over Day 0 (visit 2, surgery); optional visit 6 (second surgery).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | micrograms/gram |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the concentration of total gadolinium in trabecular bone, measured in micrograms/gram. The record says the concentration was determined by ICP-MS. Its designated summary measure is the geometric mean, accompanied by a geometric coefficient of variation (GCV), at Day 0 (visit 2, surgery), with an optional measurement at visit 6 (second surgery).
General: a concentration endpoint expresses the amount of a substance relative to the amount of sampled material. A geometric mean is a summary based on the logarithmic scale and is often useful for positive measurements that vary multiplicatively. The GCV describes relative variability on that scale; it is not the same as a standard deviation in the original units. These are general interpretations of the named statistics, not claims about the observed distribution in this study.
The endpoint addresses the study’s stated interest in whether gadolinium is present in bone tissue after prior GBCA exposure. The procedure and the tissue endpoint do not, by themselves, establish when any detected material entered the tissue or what it means clinically. The registry record does not report a numerical primary endpoint estimate for the exposure group. It notes that descriptive statistics were not performed for either control group because the specified availability and above-BLQ criterion was not met. Thus, a control-group geometric mean and GCV cannot be read as reported estimates.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary endpoint and its intended summary statistics, but it does not report a numerical concentration estimate for the exposed group. There is therefore no posted primary estimate, confidence interval, or other precision measure with which to assess the magnitude or uncertainty of trabecular-bone gadolinium concentration. The study’s stated objective is exploratory; the record does not provide a formal hypothesis test or an inferential result for this endpoint.
The control-group note requires particular care. For both control groups, the registry displays 0 (0%) and labels descriptive statistics as NA because the criterion that two-thirds of GBCA concentration values be available and above BLQ was not satisfied. This should not be interpreted as evidence that all control samples had a measured concentration of zero. NA indicates that the planned descriptive summary was not performed under the stated rule. The record further notes that 2 patients in the control group with impaired renal function had values above BLQ, with a maximum of 1.921 ug/g. That observation is not a group-level summary and does not replace a geometric mean or a comparison with the exposed group.
The study includes an exposure group and a GBCA-naive control group, but allocation is listed as NA and the record explicitly cautions that the arms are not a like-for-like control comparison. Any observed differences, if reported elsewhere, would need to be interpreted in light of the nonrandomized design and potential differences between groups. The record does not provide the information needed to evaluate adjustment for such differences. It also does not report a statistical analysis plan, so the intended handling of covariates, repeated observations, or other analytic decisions is unknown.
In general, a confidence interval describes the range of values compatible with an estimate under the assumptions of the analysis; it conveys precision as well as location. No primary endpoint confidence interval is reported in the registry record. A p-value would address a specified statistical hypothesis under a particular model, but no primary endpoint p-value is reported either. Absence of these results in the registry record does not establish that no analyses were performed outside the posted record; it means that their results cannot be evaluated from this record.
Enrollment is listed as 92, while the adverse-event groups list 74 people at risk in the GBCA exposure group and 18 in the GBCA-naive control group. Those figures describe the registry’s group entries, but the record does not explain any relationship between enrollment and the endpoint-specific analysis populations. The number with an evaluable trabecular-bone sample for the primary endpoint is not reported in the registry record. Consequently, endpoint completeness and the representativeness of analyzed samples cannot be assessed.
The listed sample-size illustrations use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. They are planning illustrations, not evidence about the study’s achieved power or a substitute for an observed result. The assumptions behind the trial’s own sample-size decision are not reported in the registry record.
9. Statistical Methods Explained
The registry specifies a geometric mean and geometric coefficient of variation for the primary gadolinium concentration endpoint. It also identifies ICP-MS as the measurement method. However, it reports 0 analyses, and the primary endpoint’s numerical result is not reported in the registry record. The statistical methods that can be described are therefore limited to the endpoint definition, the stated descriptive-statistics rule for controls, and the general meaning of the listed summaries.
What does a geometric mean describe?
General: the geometric mean summarizes positive measurements by averaging on a logarithmic scale and then expressing the result back on the original scale. It is useful when variation is naturally multiplicative, such as when values differ by relative rather than fixed absolute amounts. Unlike an arithmetic mean, it is not calculated by simply averaging the original measurements. Because a geometric mean requires positive values, handling of zero, below-quantification, or otherwise nonpositive observations must be specified for a complete analysis.
The record names the geometric mean for total gadolinium concentration in trabecular bone, but does not report the calculation details or the numerical exposed-group estimate. It also does not report whether any transformations, adjustments, or subgroup summaries were used. No conclusion about the distribution of the actual measurements should be drawn solely from the choice of geometric mean.
What does the geometric coefficient of variation add?
General: a coefficient of variation expresses dispersion relative to a central value rather than in the original measurement units. A geometric coefficient of variation applies this idea to a log-scale summary. It is intended to describe relative spread among positive measurements, while the geometric mean describes their central tendency. It is not an uncertainty interval for the mean, and it should not be read as a confidence interval.
The record names GCV as the dispersion measure but does not post a GCV value for the primary endpoint. The GCV therefore cannot be used to assess the observed variability or precision of the study’s bone measurements from this registry information.
What is the role of the BLQ rule?
BLQ means below the limit of quantification: a result that is not quantified at the assay’s stated threshold. General: measurements below this limit are not necessarily equivalent to zero. The assay may indicate that a substance is present at a level that cannot be reliably quantified, or that a quantitative value is unavailable under the method’s rules. How such values are handled can influence descriptive summaries, particularly when many observations are below the limit.
The registry note says that control-group descriptive statistics were not performed because the condition requiring two-thirds of GBCA concentration values to be available and above BLQ was not met. It reports 0 (0%) for both control groups in association with that NA status. This is a rule for whether descriptive statistics were performed, not a finding that all control samples were measured as zero. The record does not state the assay’s limit of quantification, the number of below-BLQ samples in each group, or the methods that would have been used to summarize such values if the rule had been met.
The note also states that 2 patients in the control group with impaired renal function had values above BLQ, with a maximum of 1.921 ug/g. This provides limited information about quantifiable observations in that control group, but it does not give a complete distribution, a central estimate, or an estimate of uncertainty. The registry does not state whether the noted values were included in any further analysis.
What does ICP-MS indicate?
The endpoint description identifies ICP-MS, or inductively coupled plasma mass spectrometry, as the method used to determine total gadolinium concentration. General: this analytical technique is used to measure elements in a sample. Naming the method identifies the type of measurement, but it does not provide the laboratory’s validation information, detection or quantification limits, sample preparation procedures, or quality-control results. Those details are not reported in the registry record.
How should a nonrandomized comparison be interpreted?
General: random allocation is a method for creating comparison groups that, on average, are less likely to differ systematically at baseline. This study’s allocation is listed as NA, and the record explicitly says its arms are not a like-for-like control comparison. The exposed and GBCA-naive groups may therefore differ for reasons other than exposure history. Without further design or analysis information, a difference between groups cannot automatically be attributed to prior GBCA exposure.
The record does not report an adjusted analysis, a set of covariates, or a prespecified model for comparing groups. It also does not report an analysis of the optional second-surgery measurement. In general, repeated measurements from the same person require methods that account for their dependence; whether such an analysis was planned or conducted is not reported in the registry record.
What do the planning assumptions mean?
The record describes sample-size calculations as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. General: a planning calculation estimates the sample size that would be needed under its assumptions; it does not show the probability that the completed study detected an effect. In particular, it is not observed power. The listed sample-size outputs should therefore be read as planning illustrations, not as additional outcome results. The trial’s own sample-size justification and its original design assumptions are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures, including the primary endpoint and secondary measures concerning gadolinium in skin tissue and elements in skin or bone tissue. Considering multiple outcomes raises the general issue of multiplicity: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Whether and how to adjust for multiple testing depends on the prespecified questions and analysis plan. A multiplicity strategy is not reported in the registry record.
The record reports 0 analyses and does not provide a primary endpoint estimate or numerical secondary outcome results in the registry record for this description. It therefore does not permit evaluation of the number of tests performed, the hierarchy of outcomes, or any adjustment for multiple comparisons. A statistical analysis plan, interim-analysis plan, and stopping rule are not reported in the registry record.
Missingness also affects interpretation. The control-group note states that descriptive statistics were not performed because the criterion requiring two-thirds of GBCA concentration values to be available and above BLQ was not met. The record does not report the number of missing tissue samples, reasons for unavailability, or a general missing-data method. It does not say whether missing samples were excluded, imputed, or addressed in sensitivity analyses.
The registry lists enrollment as 92 and provides group sizes for adverse-event reporting, but it does not specify the primary endpoint analysis population or the number with evaluable bone measurements. Definitions of intention-to-treat, per-protocol, or other analysis populations are not reported in the registry record. These omissions prevent assessment of whether the measured samples represent everyone enrolled or a selected subset.
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 |
|---|---|---|---|
| GBCA Exposure Group | 3 | 74 | 4.1% |
| GBCA Naive Control Group | 2 | 18 | 11.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| GBCA Exposure Group | 2 of 74 |
| GBCA Naive Control Group | 0 of 18 |
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 |
|---|---|
| GBCA Exposure Group | 35 of 74 |
| GBCA Naive Control Group | 10 of 18 |
Most frequent serious adverse event terms
| Event term | Organ system | GBCA Exposure Group | GBCA Naive Control Group |
|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | 1 of 74 | 0 of 18 |
| Overdose | Injury, poisoning and procedural complications | 1 of 74 | 0 of 18 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 1 of 74 | 0 of 18 |
| Pneumonia | Infections and infestations | 0 of 74 | 1 of 18 |
| Delirium | Psychiatric disorders | 0 of 74 | 1 of 18 |
| Renal Failure | Renal and urinary disorders | 0 of 74 | 1 of 18 |
| Nephrogenic Systemic Fibrosis | Skin and subcutaneous tissue disorders | 0 of 74 | 0 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | GBCA Exposure Group | GBCA Naive Control Group |
|---|---|---|---|
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | 12 of 74 | 4 of 18 |
| Gastrointestinal Disorders | Gastrointestinal disorders | 13 of 74 | 2 of 18 |
| Psychiatric Disorders | Psychiatric disorders | 11 of 74 | 3 of 18 |
| Vascular Disorders | Vascular disorders | 10 of 74 | 2 of 18 |
| General Disorders And Administration | General disorders | 8 of 74 | 1 of 18 |
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | 9 of 74 | 0 of 18 |
| Infections And Infestations | Infections and infestations | 5 of 74 | 2 of 18 |
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | 5 of 74 | 1 of 18 |
| Investigations | Investigations | 5 of 74 | 0 of 18 |
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | 4 of 74 | 0 of 18 |
Serious events with the highest arm-level rate: pneumonia (5.6%), delirium (5.6%), renal failure (5.6%), cardiac failure congestive (1.4%), overdose (1.4%).
The adverse-event record lists a GBCA Exposure Group with 74 at risk for serious events and 74 at risk for other events. It reports 3 serious-affect entries, 35 other-affect entries, and 2 deaths for that group. For the GBCA Naive Control Group, the corresponding at-risk counts are 18 for serious events and 18 for other events; the record reports 2 serious-affect entries, 10 other-affect entries, and 0 deaths.
The registry lists Pneumonia, Delirium, and Renal Failure at 5.6% each among the top serious terms. Cardiac Failure Congestive, Overdose, and Acute Respiratory Failure are each listed at 1.4%. These are the terms and percentages recorded; the entry does not state in this information whether each term was reported in one group or across groups.
These counts describe the safety entries in the registry and do not establish that an event was caused by GBCA exposure. The nonrandomized groups are not described as like-for-like controls, and the record does not provide adjusted safety comparisons or detailed event-level timing and attribution. The figures should be read as descriptive registry counts, not as comparative estimates of risk. The record’s definitions of the safety event categories and the method used to assign relatedness are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study addresses an exploratory measurement question: whether total gadolinium concentration can be characterized in trabecular bone from patients with a history of GBCA exposure. The registry identifies the tissue, measurement method, unit, summary statistics, and sampling timeframe. It also describes the intended exposure history and notes renal-function categories at the time of GBCA injection. These details define the scientific focus, but they do not amount to a numerical finding.
The primary endpoint’s numerical result is not reported in the registry record. The exposure-group concentration estimate and its variability therefore cannot be evaluated from this entry. The control-group descriptive statistics were marked NA because the stated availability and above-BLQ criterion was not met. The note that 2 patients in the impaired-renal-function control group had values above BLQ, with a maximum of 1.921 ug/g, is a limited observation and not a complete summary or a between-group comparison.
The design also limits causal interpretation. Allocation is listed as NA, and the record says the arms are not a like-for-like control comparison. General: in a nonrandomized comparison, differences between groups can reflect factors associated with group membership as well as the exposure being studied. The registry does not report an adjusted analysis that would clarify how such factors were addressed.
Accordingly, the entry does not establish a treatment effect, a clinical consequence of any measured concentration, or the absence of gadolinium in samples without a quantifiable result. It does not report the amount of exposure for each participant, a numerical comparison by dose history, or results by renal-function category. The optional second-surgery timeframe is listed, but results from repeated measurements are not reported.
General: a measured tissue concentration and its clinical implications are distinct questions. Concentration data describe an analytical measurement in sampled material; interpretation of clinical consequences requires evidence addressing those consequences. The registry record does not report such evidence. Its stated purpose is exploratory evaluation of potential long-term retention, and the posted information is insufficient to determine the magnitude or precision of the primary endpoint.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between a clearly identified measurement question and the limited outcome information in the registry record. The primary endpoint is specified as total gadolinium concentration in trabecular bone, with a named assay method and summary statistics. Yet the record reports 0 analyses and does not report a numerical primary endpoint estimate. Without that estimate, there is no basis in the registry entry for describing the concentration’s central level or variability in the exposure group.
The control-group note illustrates why a label such as 0 (0%) needs context. The record explicitly identifies those entries as NA for descriptive statistics because a rule about the availability and above-BLQ proportion was not satisfied. The note also reports limited above-BLQ observations in the impaired-renal-function control group. Separating a descriptive-statistics eligibility rule from an observed concentration prevents an NA entry from being mistaken for a measured zero.
The record also highlights the distinction between a comparison group and a randomized control. Although the study lists a GBCA-naive control group, allocation is NA and the registry cautions that the arms are not a like-for-like comparison. Statistical adjustment, if any, cannot be assessed because the analysis plan and adjusted results are not reported.
Finally, the registry’s planning assumptions should remain separate from evidence about study outcomes. Sample-size illustrations based on a stated fraction of an observed effect are planning tools, not observed power and not endpoint findings. For readers, the key statistical lesson is to distinguish the intended design, the available measurements, descriptive-statistics eligibility, and reported results. In this record, the endpoint is defined, but its numerical result and the methods needed to assess its precision are not reported.
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.
Several limitations specific to this record constrain interpretation. The study is marked as a single-group exploratory study, while also listing a GBCA exposure group and a GBCA-naive control group. Allocation is NA, and the registry explicitly cautions that the arms are not a like-for-like control comparison. The information does not establish that groups were comparable in renal function, exposure history, or other characteristics.
The main limitation for evaluating the primary question is that a numerical trabecular-bone concentration result is not reported in the registry record. The endpoint’s specified geometric mean and GCV are not available as results. The control groups have no descriptive statistics under the registry’s stated two-thirds availability and above-BLQ rule. The note about 2 above-BLQ observations in the impaired-renal-function control group, with a maximum of 1.921 ug/g, does not provide a full group distribution.
The primary sampling timeframe includes Day 0 (visit 2, surgery) and an optional visit 6 (second surgery). The registry does not report how many people contributed samples at either time, whether the optional visit occurred for all eligible participants, or how any within-person measurements were analyzed. The endpoint-specific analysis population and sample completeness are not reported.
The record does not provide the assay’s quantification limit, detailed laboratory procedures, missing-data methods, covariate adjustment, or the statistical analysis plan. It also does not report the trial’s sample-size justification, interim analyses, or a multiplicity approach for the 21 outcome measures. These details cannot be inferred from the listed endpoint or the planning assumptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Long-Term Retention of Gadolinium in Bone — NCT01853163.
- Registry record last updated 2022-09-28; status last verified 2020-06.
- Results first posted 2022-09-28.
- 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 completed exploratory study of long-term gadolinium retention in bone, sponsored by Navitas Life Sciences GmbH. It lists enrollment of 92, a study start date of 2013-05-06, and a primary completion date of 2018-12-05. The primary endpoint is total gadolinium concentration in trabecular bone, measured by ICP-MS and intended to be summarized by geometric mean and geometric coefficient of variation. The listed timeframe is Day 0 (visit 2, surgery), with an optional visit 6 (second surgery).
The study concerns patients with prior GBCA exposure and includes a GBCA-naive control group. It is not described as randomized, and the registry cautions that its arms are not a like-for-like comparison. The record lists 21 outcome measures and 0 analyses. The primary endpoint’s numerical result is not reported in the registry record. Control-group descriptive statistics were marked NA under the stated availability and above-BLQ rule. The registry therefore defines the measurement question but does not provide the numerical primary results needed to assess their magnitude or precision.