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 Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer (NCT00859027), a randomized phase 4 study. The primary outcome is Percent Change in Bone Mineral Density.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00859027 |
| Phase | Phase 4 |
| Condition | Prostate Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | UConn Health |
| Results posted | Yes |
2. Clinical Question
Population
Older men with prostate cancer receiving neoadjuvant therapy are the population described by the trial title and summary. The registry record explains that hormonal suppression with LHRH-agonists such as leuprolide and goserelin is associated with hypogonadism, increased bone turnover, and bone loss at the hip and spine. It does not report further eligibility criteria or a more detailed description of the participants included in the primary analysis.
Intervention
The intervention was risedronate, described as 35 mg by mouth every week as directed. This is the regimen named in the registry summary and arm description. The record does not provide adherence information or details about how treatment exposure was measured.
Comparator
The comparator is described as a placebo risedronate oral tablet, with the arm description specifying calcium and vitamin D. The record names the two groups as Risedronate and Calcium and Vitamin D. It does not give further details about the calcium and vitamin D regimen.
Primary question
The primary outcome was percent change in bone mineral density (BMD), measured at baseline and 6 months. The underlying BMD measures were taken at the femoral neck, total hip, and lumbar spine (L1-L4). The registry summary states that risedronate may prevent bone loss in this setting, but the registry record does not report numerical results for the primary outcome. Therefore, the record alone does not establish the size or precision of a between-group difference.
3. Trial Design
This was a randomized, double-masked, parallel-group Phase 4 trial sponsored by UConn Health. The registry lists an enrollment of 50 and a status of completed. The study began in 2003-01, and primary completion was recorded as 2008-03. The title identifies older men receiving neoadjuvant therapy for prostate cancer as the study population.
The two intervention groups were risedronate and a placebo risedronate oral tablet. The risedronate arm description specifies 35 mg by mouth every week as directed; the comparator arm description specifies calcium and vitamin D. Randomization indicates that participants were assigned by chance, while double masking indicates that masking was used for two groups of people involved in the trial. The registry record does not identify who was masked or describe how randomization and masking were implemented.
A parallel-group design assigns participants to a group and compares outcomes between groups rather than having each participant receive each intervention in sequence. For a continuous outcome such as BMD change, the central statistical question is generally how the groups' outcome distributions compare. The registry record does not report a specific statistical model or an analysis population for that comparison.
The primary outcome is percent change in BMD at baseline and 6 months. The registry also lists percent change of bone turnover markers as a secondary outcome. It records two outcome measures and seven analyses, but does not explain the relationship among all analyses or identify which analyses correspond to each outcome. A single comparison was not produced from the primary outcome because it has several categories or time points. Further details of eligibility, allocation procedures, follow-up, and protocol deviations are not reported in the registry record.
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 | Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily | Calcium and Vitamin D Daily (Placebo Group) |
|---|---|---|
| STARTED | 25 | 25 |
| COMPLETED | 20 | 20 |
| NOT COMPLETED | 5 | 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 | Risedronate Plus Calcium and Vit D | Calcium and Vitamin D | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 25 | 50 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 17 | 18 | 35 |
| Age, Categorical: >=65 years | Participants | 8 | 7 | 15 |
| Age, Continuous | years | 70 (SD 9) | 72 (SD 7) | 71 (SD 8) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 25 | 25 | 50 |
| Region of Enrollment: United States | participants | 25 | 25 | 50 |
6. Primary Endpoint
The registry lists the primary outcome as Percent Change in Bone Mineral Density, measured over baseline and 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Percent Change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percent change in bone mineral density (BMD), a continuous measure of bone mass. BMD was measured by dual-energy X-ray absorptiometry using a Lunar DXA-IQ. The recorded skeletal sites were the femoral neck, total hip, and lumbar spine (L1-L4), with the outcome timeframe described as baseline and 6 months.
Percent change expresses the change in a measure relative to its baseline level. In general, using a change measure can help describe how an outcome shifts over follow-up, while site-specific measurements distinguish results for different parts of the skeleton. These are general statistical considerations; the registry record does not explain why this endpoint or these sites were selected.
The outcome is reported as a mean with standard error. A mean describes the average observed value in a group, while the standard error describes uncertainty in the estimated mean. It is not the same as the spread of individual participants' measurements. The registry notes that the underlying data are no longer available and that reported means have been estimated from the results publication. Numerical means and standard errors are not reported in the registry record, so the magnitude and precision of the endpoint cannot be assessed from the record alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized, double-masked, parallel-group comparison of weekly risedronate with a placebo risedronate oral tablet, whose arm description specifies calcium and vitamin D. The primary outcome is percent change in BMD at baseline and 6 months, assessed at the femoral neck, total hip, and lumbar spine (L1-L4). These details establish the clinical topic and outcome structure, but do not establish the observed difference between groups.
No numerical primary-outcome means, standard errors, effect estimates, confidence intervals, or p-values are reported in the registry record. The record notes that BMD means were estimated from the results publication because underlying data are no longer available. Without the numerical estimates, it is not possible to describe whether the groups' recorded mean changes differed, by how much they differed, or how precisely a difference was estimated. The record's summary statement about prevention of bone loss is not a substitute for a numerical between-group result.
The outcome includes multiple skeletal sites, and the primary outcome was not reduced to one comparison because it has several categories or time points. Results at different sites can vary, and a finding at one site should not automatically be treated as a finding at another. The registry record does not supply the site-specific estimates needed to assess that pattern. It also does not report a prespecified primary contrast among the sites or describe how the multiple outcome comparisons were handled.
In general, a confidence interval communicates the range of effect values compatible with the data and analysis, subject to the method's assumptions. Its width is informative about precision; it does not by itself establish clinical importance. A p-value addresses compatibility between observed data and a specified null model, rather than the probability that a treatment works. Neither type of result can be interpreted for this primary outcome from the information recorded here, because the corresponding numerical results are not reported in the registry record.
Enrollment was 50. The safety group summaries list 25 participants at risk in each group, but these denominators should not be substituted for an analysis-specific sample size for BMD. The record does not report how many participants contributed primary-outcome measurements at each skeletal site or time point, or how missing measurements were handled. Consequently, the available registry description supports a cautious account of the design and measurement plan, not a conclusion about the size, direction, or precision of the primary-outcome comparison.
9. Statistical Methods Explained
The trial is described as randomized, double-masked, and parallel-group. The primary outcome is continuous: percent change in BMD, summarized using a mean and standard error. The registry record identifies measurement sites and a baseline and 6-month timeframe, but does not report a specific model, test, or adjustment strategy for the primary analysis.
What does randomization contribute?
In general, randomization assigns participants to groups by chance. Its statistical purpose is to reduce systematic differences between groups at the point of assignment, so that a group comparison can be interpreted with less concern that measured or unmeasured baseline factors determined the assignment. Randomization does not guarantee that the groups will be identical, especially in a trial with limited enrollment. It also does not remove the need to account for missing outcomes, departures from assigned treatment, or outcome measurement procedures.
The registry identifies the study as randomized but does not describe the sequence-generation method, allocation concealment, or implementation. These details are not reported in the registry record. The group sizes used for the BMD analysis are also not reported, so enrollment alone does not establish how many observations informed each estimate.
What does double masking mean for interpretation?
Masking is intended to reduce the influence of knowledge about assigned treatment on trial conduct or outcome assessment. The registry classifies the study as double-masked, but does not specify which participants, clinicians, assessors, or other personnel were masked. It also does not describe the procedures used to maintain masking or whether masking was assessed. Those details matter because the label alone does not show how masking operated in practice.
How should a mean and standard error be read?
A mean summarizes the average measurement in a group. The standard error describes the uncertainty in estimating that group mean, rather than the variability among individual participants. In general, a standard error is used to assess the precision of an estimated mean and can contribute to an interval estimate or hypothesis test. It does not, by itself, describe the full distribution of individual measurements.
The record says the underlying BMD data are no longer available and the reported means were estimated from the results publication. It does not give the numerical means or standard errors in the registry record. Therefore, no independent assessment of their precision, the difference between groups, or the assumptions behind those estimates is possible from this record alone.
Why do multiple sites and time points matter?
The primary outcome covers the femoral neck, total hip, and lumbar spine (L1-L4), and the timeframe is baseline and 6 months. Distinct sites are distinct outcome categories: the values may not move in the same way, and each comparison can carry its own uncertainty. In general, examining multiple outcomes also raises a multiplicity question: when many comparisons are made, the chance of at least one apparently unusual result can increase. Whether and how to control that issue depends on the intended interpretation and analysis plan.
The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not report a hierarchy among sites, a designated primary site-specific contrast, or a multiplicity procedure. The seven analyses recorded in the registry are not described in enough detail to determine how they relate to the outcome categories.
What can a planning calculation tell us?
In general, sample-size planning considers a target effect, the variability of the outcome, a significance threshold, and a desired probability of detecting the target effect if it is present under the planning assumptions. Planning illustrations based on an observed effect are not observed power and do not show that a trial was adequately designed before enrollment. The registry record does not report the trial's own sample-size justification or provide the numerical inputs needed to evaluate one. Any design rationale beyond the stated registry information is not reported in the registry record.
For continuous outcomes, the choice of statistical model also matters. A model may account for baseline outcome values, repeated measurements, or other covariates, but the appropriate approach depends on the design and analysis plan. The registry record does not identify whether any such adjustment was used. The reported endpoint description alone should not be taken to imply a particular model, test, or estimate.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes multiple BMD categories or time points, and the registry indicates that it was not reduced to one comparison. The listed sites are the femoral neck, total hip, and lumbar spine (L1-L4), with a baseline and 6-month timeframe. Percent change of bone turnover markers is listed as a secondary outcome. In general, assessing multiple outcomes can complicate interpretation because a collection of comparisons is not equivalent to a single prespecified test. The registry record does not report a multiplicity adjustment, an outcome hierarchy, or a rule for interpreting results across sites and outcomes.
The record lists two outcome measures and seven analyses but does not describe each analysis or identify which were primary, secondary, or exploratory beyond the named outcomes. An analysis plan, including any prespecified contrast or adjustment for baseline values, is not reported in the registry record. Interim analyses and any associated decision rules are also not reported in the registry record.
Missing-data methods are not described. The registry notes that underlying BMD data are no longer available and that reported means were estimated from the results publication. It does not state how many participants had measurements available at each site and time point, why measurements may have been missing, or how missingness was handled in the analysis. Those details are important because estimates based on available measurements may differ from estimates under other assumptions about participants without measurements.
The analysis population is not specified in the registry record. It is therefore not possible to determine from the record whether the primary analysis included all randomized participants, participants who received assigned treatment, or another group. No assumptions about the analysis population or missing-data handling should be inferred from the randomized design alone.
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 |
|---|---|---|---|
| Calcium and Vitamin D | 0 | 25 | 0.0% |
| Risedronate | 0 | 25 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Calcium and Vitamin D | 0 of 25 |
| Risedronate | 0 of 25 |
The serious adverse event summary lists 25 participants at risk in the Calcium and Vitamin D group and 25 at risk in the Risedronate group. It records 0 participants affected by a serious adverse event in each group. The other adverse event counts likewise list 25 at risk and 0 affected in each group. These are the registry's posted counts; they do not provide detailed event descriptions or an account of how adverse events were collected.
A count of 0 affected means no affected participants are recorded in that category for the listed group. It does not establish that no adverse events occurred outside the registry's reported categories, nor does it determine the likelihood of an event beyond the trial observations. The record does not report event definitions, severity criteria, follow-up duration for safety, or a statistical comparison of safety outcomes. Death counts are not reported in the registry record.
These figures should be read as a limited summary of recorded events, not as a complete safety assessment or as proof of absence of risk. The denominators in the safety summary are not necessarily the number of participants included in the primary BMD analysis; the analysis-specific numbers are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked, parallel-group Phase 4 trial compared weekly risedronate with a placebo risedronate oral tablet, described in the arm details as calcium and vitamin D. It enrolled 50 participants and listed percent change in BMD at baseline and 6 months as the primary outcome. The measured sites were the femoral neck, total hip, and lumbar spine (L1-L4).
What the record does not establish is the magnitude or precision of the primary comparison. Numerical BMD means, standard errors, between-group estimates, confidence intervals, and p-values are not reported in the registry record. The summary's statement that bone loss can be prevented is a description of the trial rationale or claim, not a numerical result that permits an independent assessment of the observed data. The registry also notes that BMD means were estimated from a results publication because the underlying data are no longer available.
In general, a statistically detectable difference and a clinically meaningful difference are distinct ideas. Statistical uncertainty concerns how precisely an effect is estimated; clinical importance concerns whether the size and context of the effect matter. Neither can be assessed for the primary outcome using only the numerical information recorded in the registry record. Results at one skeletal site would not automatically establish the same pattern at other sites.
The record's safety summary reports no affected participants in the listed serious or other adverse event categories in either group, with 25 at risk in each group. This is a bounded registry summary, not evidence that all possible adverse events were absent. Details about event definitions and ascertainment are not reported in the registry record.
Accordingly, the registry supports description of the trial question, design, outcome measurements, and recorded safety counts. It does not support a quantitative conclusion about the comparative BMD effect, its precision, or its consistency across sites.
13. Why This Trial Matters Statistically
This trial is statistically notable for the structure of its primary outcome. BMD was assessed at the femoral neck, total hip, and lumbar spine (L1-L4), and the outcome timeframe includes baseline and 6 months. A set of site-specific and time-related measurements requires careful definition of the comparison of interest. Without a stated hierarchy or a single prespecified contrast, readers need to know how the analyses relate to one another before treating any result as definitive. The registry record does not report that analysis structure in detail.
The record also illustrates the importance of separating a treatment rationale from an estimated treatment effect. The summary describes a biological rationale involving hormonal suppression, bone turnover, and bone loss, and names risedronate as the intervention. But an explanatory rationale does not quantify the observed comparison. Numerical endpoint estimates and uncertainty measures are not reported in the registry record, limiting statistical interpretation.
Another statistical issue is the distinction between group summaries and individual-level data. The registry says the underlying BMD data are no longer available and that reported means were estimated from the results publication. Individual-level data would ordinarily permit additional checks, such as examining distributions, confirming calculations, or applying alternative analyses. Such checks cannot be made from the information recorded.
Finally, the safety summary illustrates why zero recorded events should be interpreted within the scope of the event definitions and follow-up that were used. Those details are not reported in the registry record. Overall, the trial's registry information makes clear what was studied, while leaving key details needed to assess effect size, uncertainty, multiplicity, and analysis populations undocumented.
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 primary limitation for interpreting the treatment comparison is the absence of numerical primary-outcome results in the registry record. Although the outcome is identified and the record says means were estimated from a results publication, the numerical means and standard errors are not reported. The underlying BMD data are no longer available according to the registry description. This prevents assessment of the direction, magnitude, and precision of the group comparison from the registry record alone.
The endpoint covers more than one skeletal site and includes a baseline and 6-month timeframe, but the record does not provide site-specific estimates, identify a priority site, or describe a single primary contrast. It also lists two outcome measures and seven analyses without explaining their full relationship. A multiplicity strategy is not reported in the registry record.
Details needed to evaluate the conduct of the analysis are also absent. The record does not describe the randomization method, the masking procedures, the analysis population, the number of participants with outcome data at each site, or the handling of missing measurements. It does not report the statistical model or whether baseline values or other variables were used in adjustment. These items should be treated as unreported rather than inferred from the design label.
The adverse event summary is limited to counts of participants affected in listed categories. Event definitions, collection procedures, and safety follow-up details are not reported in the registry record; death counts are also not reported. These limitations restrict the conclusions that can be drawn from the posted safety figures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer — NCT00859027.
- Registry record last updated 2018-05-01; status last verified 2018-04.
- Results first posted 2013-08-01.
- 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 NCT00859027, titled Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer. It is a completed, randomized, double-masked, parallel-group Phase 4 trial sponsored by UConn Health, with enrollment of 50. The study began in 2003-01 and primary completion was recorded in 2008-03.
The intervention was risedronate, described as 35 mg by mouth every week as directed. The comparator was a placebo risedronate oral tablet, with the arm description specifying calcium and vitamin D. The primary outcome was percent change in BMD at baseline and 6 months, measured at the femoral neck, total hip, and lumbar spine (L1-L4). Percent change of bone turnover markers was listed as a secondary outcome.
The registry says the underlying BMD data are no longer available and that reported means were estimated from the results publication. Numerical primary-outcome estimates and analysis details are not reported in the registry record. The safety summary lists 25 participants at risk and 0 affected in each group for both serious and other adverse event categories.