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 Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis (NCT00619957), a randomized phase 3 study. The primary outcome is Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00619957 |
| Phase | Phase 3 |
| Condition | Other Osteoporosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 285 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Warner Chilcott |
| Results posted | Yes |
2. Clinical Question
Population
Men with osteoporosis were eligible for the trial. The condition is recorded as Other Osteoporosis. The primary outcome uses the intention-to-treat population with last observation carried forward.
Intervention
Participants assigned to risedronate received a 35 mg tablet once a week for 2 years, followed by open-label 35 mg risedronate once a week for 2 years.
Comparator
Participants assigned to placebo received a placebo tablet once a week for 2 years, followed by once-weekly risedronate for 2 years.
Primary question
How did lumbar spine bone mineral density change from baseline to 24 months or endpoint in the risedronate and placebo groups during the randomized comparison?
The main comparison concerns a measured change in bone mineral density, not a clinical event such as a fracture. The registry reports least-squares mean percent change for each group and an analysis of the between-group difference. The posted group estimates were 1.22 for placebo and 5.75 for risedronate. The sponsor-reported difference was 4.53, with a 95% confidence interval from 3.46 to 5.60 and p < 0.001.
The randomized comparison lasted 2 years. Both groups then had a risedronate phase, but the placebo group received risedronate only after its initial placebo period. The open-label follow-up therefore does not preserve a placebo comparison for the full study duration. The primary question is specifically about the baseline-to-endpoint lumbar spine measurement in the reported primary analysis, rather than a comparison of treatments across the entire 4-year study.
3. Trial Design
This was a phase 3, randomized, double-blind, parallel-group trial sponsored by Warner Chilcott. The registry records 285 participants enrolled and a completed study. The recorded start was 2002-06, and primary completion was 2007-05. The official title describes a 2-year study followed by a 2-year open-label study.
During the first 2 years, one group received weekly risedronate and the other received a weekly placebo tablet. The subsequent 2 years were open label: both groups were assigned once-weekly risedronate, with the former placebo group starting risedronate after its initial placebo period. Because treatment assignment and the comparison changed after the randomized period, the main controlled comparison is the first 2 years.
The primary outcome analysis reports 188 participants in the risedronate arm and 87 in the placebo arm. These analysis counts should not be confused with the registry's overall enrollment. The registry does not report why the analyzed group sizes differ, nor does it give further detail on participant flow in the record.
The primary outcome was analyzed in the intention-to-treat population using last observation carried forward. A least-squares mean was reported for each group, and an ANOVA analysis reported the difference between groups. The record identifies a 95% confidence interval for those estimates. It does not report the randomization procedure, allocation concealment details, or the protocol's sample-size justification. Those design details should not be inferred from the randomized and double-blind labels.
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.
Month 24 Double-Blind
| Stage | Placebo | Risedronate |
|---|---|---|
| STARTED | 93 | 192 |
| Intent to Treat (ITT Population) | 93 | 191 |
| COMPLETED | 75 | 175 |
| NOT COMPLETED | 18 | 17 |
Reasons for not completing this period:
| Reason | Placebo | Risedronate |
|---|---|---|
| Adverse Event | 9 | 7 |
| Protocol Violation | 1 | 0 |
| Withdrawal by Subject | 7 | 9 |
| Lost to Follow-up | 1 | 0 |
| Did not take any study medication | 0 | 1 |
Month 48 Open-Label
| Stage | Placebo | Risedronate |
|---|---|---|
| STARTED | 67 | 151 |
| COMPLETED | 55 | 134 |
| NOT COMPLETED | 12 | 17 |
Reasons for not completing this period:
| Reason | Placebo | Risedronate |
|---|---|---|
| Adverse Event | 4 | 4 |
| Lost to Follow-up | 2 | 4 |
| Withdrawal by Subject | 6 | 9 |
Analysis population for the primary outcome, as defined in the registry: ITT Population, LOCF (Last Observation Carried Forward)
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 | Placebo | Risedronate | Total |
|---|---|---|---|---|
| Participants analysed | 93 | 192 | 285 | |
| Age, Customized: < 65 years | participants | 49 | 120 | 169 |
| Age, Customized: Between 65 and <75 years | participants | 34 | 51 | 85 |
| Age, Customized: >=75 years | participants | 10 | 20 | 30 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 93 | 192 | 285 |
| Region of Enrollment: Australia | participants | 3 | 7 | 10 |
| Region of Enrollment: Belgium | participants | 12 | 24 | 36 |
| Region of Enrollment: Czech Republic | participants | 5 | 12 | 17 |
| Region of Enrollment: France | participants | 2 | 7 | 9 |
| Region of Enrollment: United Kingdom | participants | 3 | 6 | 9 |
| Region of Enrollment: Hungary | participants | 11 | 20 | 31 |
| Region of Enrollment: Lebanon | participants | 2 | 4 | 6 |
| Region of Enrollment: Netherlands | participants | 3 | 7 | 10 |
| Region of Enrollment: Poland | participants | 35 | 73 | 108 |
| Region of Enrollment: United States | participants | 17 | 32 | 49 |
6. Primary Endpoint
The registry lists the primary outcome as Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population., measured over Baseline to 24 Months/Endpoint.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Percent Change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percent change from baseline in lumbar spine bone mineral density at 24 months or endpoint, in the intention-to-treat population. Bone mineral density is a quantitative measure of mineral content in bone. The endpoint expresses change relative to the participant's baseline measurement, allowing the analysis to compare change over the study period rather than only the final measurement.
The registry describes measurement by dual-energy X-ray absorptiometry, or DXA, using Lunar or Hologic machines. It states that a site's screening scan could be forwarded to a central facility for analysis, that the mean of 2 scans read by a central laboratory was used to determine entry qualification, and that results were standardized using machine-specific formulas. These measurement procedures matter because readings from different machines can require standardization to support comparability.
Bone mineral density is used as a continuous outcome: each participant's measurement can take a range of values rather than being limited to an event/no-event category. The reported group results are least-squares means, with 95% confidence intervals. The endpoint can describe change in a measured skeletal quantity, but it is not itself a count of fractures or another clinical event. The registry does not report a fracture endpoint among the listed primary results.
For this analysis, the stated population is intention to treat with last observation carried forward. That means the reported primary analysis uses the recorded intention-to-treat population and carries the last available observation forward for missing endpoint measurements. The record does not provide further details about the timing or extent of missing measurements.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results show a least-squares mean percent change of 5.75 in the risedronate group and 1.22 in the placebo group at 24 months or endpoint. The sponsor-reported ANOVA comparison gives a between-group difference of 4.53, with a 95% confidence interval from 3.46 to 5.60 and p < 0.001. The interval is entirely above zero, indicating that the reported data are compatible with a larger mean increase in the risedronate group than in the placebo group under this analysis.
The group confidence intervals are 5.0 to 6.5 for risedronate and 0.23 to 2.21 for placebo. A confidence interval describes a range of values compatible with the data and the analysis assumptions; it does not mean that individual participants' changes fall within that range. The between-group interval is the more direct uncertainty measure for the treatment comparison. It reflects uncertainty in the estimated difference, rather than variability among all individual measurements.
The result is a comparison of a continuous measurement, not a comparison of fracture rates or another patient-level clinical outcome. The reported difference is in percent change in lumbar spine bone mineral density. It should therefore be interpreted as evidence about the measured endpoint in the reported population and period, not as a direct estimate of clinical benefit or harm.
The analysis population is described as intention to treat with last observation carried forward. This approach retains participants according to the trial's intention-to-treat framework while replacing a missing endpoint with the participant's last observed value. Such carried-forward values can affect the estimate if participants with missing measurements would otherwise have changed differently. The registry does not report the amount or pattern of missing outcome data, so the extent to which this issue influenced the result cannot be assessed from the record.
The secondary results include other bone mineral density measures and a responder outcome, but they do not replace the prespecified primary comparison. Secondary findings should be read in light of their number and the lack of a reported multiplicity adjustment. The registry record supports a clear primary-endpoint difference under the stated analysis, while leaving uncertainty about broader clinical outcomes, missing-data sensitivity, and the interpretation of multiple secondary tests.
9. Statistical Methods Explained
The primary analysis compares a continuous outcome: percent change in lumbar spine bone mineral density. Continuous outcomes preserve information about the magnitude of each measurement, rather than reducing results to a yes/no classification. The registry reports least-squares means for the two groups and an ANOVA comparison of their difference.
What does a least-squares mean represent?
A least-squares mean is a model-based estimate of a group mean. It is often used when an analysis estimates group outcomes within a statistical model. The registry reports least-squares means of 1.22 for placebo and 5.75 for risedronate. The record does not describe all model terms or adjustments, so the precise modeling specification beyond the named ANOVA method is not reported in the registry record.
How should the confidence intervals be read?
A confidence interval conveys uncertainty around an estimated quantity under the model and sampling assumptions. The primary group estimates have 95% confidence intervals of 0.23 to 2.21 for placebo and 5.0 to 6.5 for risedronate. The reported difference has a 95% confidence interval from 3.46 to 5.60. The interval for the difference addresses the treatment contrast directly. Confidence intervals are not ranges containing a stated proportion of individual participant outcomes, and they do not account for every possible source of bias or uncertainty.
What does the p-value add?
The ANOVA analysis reports p < 0.001 for the between-group comparison. A p-value describes how unusual data at least as incompatible with the null comparison would be under the test's assumptions if the null hypothesis were true. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of the observed difference. The estimate and its confidence interval provide information about magnitude and precision alongside the p-value.
Why does the intention-to-treat population matter?
The primary population is identified as intention to treat, with last observation carried forward. An intention-to-treat approach generally aims to analyze participants according to their assigned group, preserving the randomized comparison. The record's specific analysis population is labeled ITT, but it does not provide further information about exclusions or the exact handling of every participant's data. Last observation carried forward substitutes a participant's last recorded measurement for a missing later measurement. It assumes, for the purpose of that substitution, that the last observed value is an acceptable stand-in for the missing endpoint. If outcomes continue to change after the last observation, that substitution may not represent the unobserved value. The amount and pattern of missingness and sensitivity analyses are not reported in the registry record.
How does the secondary responder analysis differ?
A responder endpoint converts a continuous measurement into a category, classifying participants according to a response definition. The registry reports a lumbar spine BMD responder outcome at Month 24 and a Cochran-Mantel-Haenszel analysis. That test is commonly used for categorical comparisons, including analyses that account for strata. The registry does not specify the strata or the response threshold in the record. A separate unadjusted recalculation reports a risk difference and associated uncertainty. A risk difference expresses the difference between two event proportions; it is distinct from the primary endpoint's difference in mean percent change. Recalculated analyses are simple unadjusted analyses of posted summary information and should not be mistaken for the sponsor's full analysis.
Why does over-dispersion matter in general?
For count outcomes, over-dispersion means that observed variability is greater than a model's assumed variability. It can make standard errors too small if ignored. This is a general statistical consideration, not a feature established for this primary endpoint: the primary outcome is continuous, and the registry does not report an over-dispersion assessment.
What are the planning illustrations?
Planning illustrations based on an observed effect can show how a future study's required group size changes when the effect to detect is smaller than the observed one. They are not observed power for this trial and are not evidence that the original study was designed using those assumptions. The stated illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It gives participants per arm for 80% power and participants per arm for 90% power for planning at 100%, 75%, and 50% of the observed effect. The registry does not report the trial's own sample-size justification, so these planning values should not be attributed to the original protocol.
The registry reports 37 outcome measures and 37 analyses, and 36 secondary outcomes are posted. The record does not report a statistical plan for controlling the chance of false-positive findings across multiple secondary tests. The primary comparison and secondary analyses therefore have different interpretive roles: the former is the stated primary endpoint, while the latter are additional findings that need cautious interpretation.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANOVA | Least Square (LS) Mean Difference 4.53 | 3.46 to 5.60 | < 0.001 |
The sponsor-reported primary analysis uses ANOVA and gives a least-squares mean difference of 4.53, with a 95% confidence interval from 3.46 to 5.60 and p < 0.001. That analysis is the principal reported inference for the primary endpoint. The registry record does not flag a discrepancy between the posted primary result and a recalculation.
For the secondary responder outcome, the sponsor-reported analysis is Cochran-Mantel-Haenszel, with p < 0.001. A separate recalculation from the posted group summaries is unadjusted and reports its own risk-difference estimate and interval. The two analyses are not interchangeable: the sponsor's method may account for features not represented in a simple recalculation, and the registry does not specify the strata for the sponsor's test. The sponsor's reported analysis should therefore be kept distinct from the unadjusted recalculation.
Recalculated results are useful as a check on summary data, but they do not reproduce an analysis using participant-level information or undisclosed model details. They also do not replace the sponsor's own stated test. No discrepancy is flagged in the registry record, and the reported primary ANOVA result remains the main basis for describing the primary comparison.
11. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several statistical hypotheses are tested. Even if each individual test uses a conventional significance threshold, testing many outcomes can increase the chance that at least one result appears statistically significant by chance. The registry lists 37 outcome measures and 37 analyses, with 36 secondary outcomes posted. A multiplicity adjustment, testing hierarchy, or other strategy for interpreting multiple outcomes is not reported in the registry record.
This matters most for interpreting secondary results. Their p-values should not be read as if each were the only test undertaken. Without a reported adjustment or prespecified hierarchy, secondary findings are more appropriately treated as exploratory or supportive than as equally strong confirmation of the primary result. The record does not establish whether a multiplicity plan existed outside the registry entry.
The primary analysis is described as intention to treat with last observation carried forward. This identifies the population and one method for filling missing endpoint values, but it does not show how many measurements were missing, when they were missing, or whether missingness differed by group. The record does not report sensitivity analyses using alternative missing-data assumptions. Carrying the last observation forward can be problematic when the outcome would plausibly change after that measurement; it may either overstate or understate the unobserved endpoint, depending on the pattern of change.
The record also does not provide detailed participant-flow information for the primary endpoint, reasons for missing measurements, or a full analysis plan. These omissions limit assessment of the robustness of the estimate. They do not establish that the analysis was biased, but they prevent a reader from evaluating how sensitive the result might be to missing data or to decisions about analysis populations.
Finally, the planning illustrations use the observed effect and stated assumptions to show possible future-study group sizes. They do not document the original trial's sample-size rationale or resolve uncertainty about missingness or multiplicity. The trial's own sample-size justification and interim-analysis plan are not reported in the registry record.
12. 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 |
|---|---|---|---|
| Placebo Year 2 | 15 | 93 | 16.1% |
| Risedronate Year 2 | 29 | 191 | 15.2% |
| Placebo-Risedronate Year 4 | 8 | 67 | 11.9% |
| Risedronate Year 4 | 21 | 151 | 13.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo Year 2 | 66 of 93 |
| Risedronate Year 2 | 134 of 191 |
| Placebo-Risedronate Year 4 | 46 of 67 |
| Risedronate Year 4 | 97 of 151 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo Year 2 | Risedronate Year 2 | Placebo-Risedronate Year 4 | Risedronate Year 4 |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | 3 of 93 | 1 of 191 | 1 of 67 | 3 of 151 |
| Atrial Fibrillation | Cardiac disorders | 1 of 93 | 1 of 191 | 2 of 67 | 3 of 151 |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | 1 of 93 | 0 of 191 | 2 of 67 | 2 of 151 |
| Inguinal Hernia | Gastrointestinal disorders | 0 of 93 | 2 of 191 | 1 of 67 | 2 of 151 |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 93 | 2 of 191 | 0 of 67 | 1 of 151 |
| Coronary Artery Disease | Cardiac disorders | 1 of 93 | 2 of 191 | 0 of 67 | 0 of 151 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 2 of 93 | 1 of 191 | 0 of 67 | 0 of 151 |
| Angina Pectoris | Cardiac disorders | 1 of 93 | 0 of 191 | 1 of 67 | 0 of 151 |
| Appendicitis | Infections and infestations | 1 of 93 | 1 of 191 | 0 of 67 | 0 of 151 |
| Arrhythmia | Cardiac disorders | 0 of 93 | 1 of 191 | 0 of 67 | 1 of 151 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo Year 2 | Risedronate Year 2 | Placebo-Risedronate Year 4 | Risedronate Year 4 |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 5 of 93 | 11 of 191 | 2 of 67 | 12 of 151 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 8 of 93 | 11 of 191 | 2 of 67 | 7 of 151 |
| Back Pain | Musculoskeletal and connective tissue disorders | 2 of 93 | 13 of 191 | 3 of 67 | 10 of 151 |
| Constipation | Gastrointestinal disorders | 5 of 93 | 16 of 191 | 0 of 67 | 0 of 151 |
| Hypertension | Vascular disorders | 4 of 93 | 5 of 191 | 1 of 67 | 11 of 151 |
| Influenza | Infections and infestations | 5 of 93 | 11 of 191 | 1 of 67 | 4 of 151 |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | 3 of 93 | 9 of 191 | 3 of 67 | 5 of 151 |
| Headache | Nervous system disorders | 0 of 93 | 10 of 191 | 0 of 67 | 9 of 151 |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | 3 of 93 | 9 of 191 | 0 of 67 | 5 of 151 |
| Upper Respiratory Tract Infection | Infections and infestations | 3 of 93 | 7 of 191 | 2 of 67 | 4 of 151 |
Serious events with the highest arm-level rate: myocardial infarction (3.2%), atrial fibrillation (3.0%), gastrooesophageal reflux disease (3.0%), chest pain (2.2%), pulmonary embolism (2.2%).
The registry reports serious and other adverse-event counts separately for the Year 2 groups and the Year 4 groups. At Year 2, the serious-event figures are 15 of 93 for placebo and 29 of 191 for risedronate. At Year 4, the figures are 8 of 67 for the placebo-risedronate group and 21 of 151 for the risedronate group. These are counts within the registry's stated at-risk group sizes; they should be read within the relevant study period and group rather than combined across periods.
The record also lists serious-event terms with percentages, including myocardial infarction, atrial fibrillation, gastrooesophageal reflux disease, chest pain, pulmonary embolism, and angina pectoris. The denominator and method for those term percentages are not reported in the registry record. The figures do not, by themselves, establish that an event was caused by treatment or that risks differ between groups. The registry record does not report deaths in these entries. Adverse-event summaries are descriptive and need to be interpreted alongside the study's follow-up, definitions, and participant exposure.
13. What the Result Does, and Does Not, Mean
The primary result means that the reported analysis estimated a larger mean increase in lumbar spine bone mineral density for the risedronate group than for the placebo group over the primary comparison period. The estimated between-group difference was 4.53, with a 95% confidence interval from 3.46 to 5.60 and p < 0.001. The estimate is precise enough to distinguish the reported group means under the analysis, while still being subject to the study's design, measurement, and missing-data limitations.
It does not show that every participant's bone mineral density increased, or that individual outcomes fell within the confidence interval. It also does not directly quantify fracture prevention, symptoms, function, or quality of life. The primary endpoint is a measured change in bone mineral density, and the registry record does not report a fracture result among the primary outcomes.
The randomized and double-blind design supports a controlled comparison during the first 2 years, but the registry entry does not provide all details needed to assess implementation, such as allocation concealment or participant flow. The later phase was open label and both groups received risedronate, so it does not provide the same placebo-controlled contrast as the randomized phase.
The results should also be understood alongside the intention-to-treat analysis using last observation carried forward. The missing-data amount and sensitivity analyses are not reported in the registry record. Secondary outcomes broaden the measurement context but involve multiple tests, and a multiplicity strategy is not reported. Thus, the primary estimate is the clearest statistical finding, while broader claims require evidence not contained in this endpoint result.
14. Why This Trial Matters Statistically
This trial illustrates the difference between measuring a biological quantity and measuring a clinical event. The primary endpoint is a continuous change in lumbar spine bone mineral density, which supports estimation of an average difference and its confidence interval. That statistical structure differs from an event endpoint, where the analysis would focus on whether an event occurred and how often.
The report also shows why a direct comparison estimate is more informative than looking only at separate group estimates. The ANOVA result provides a between-group difference and its interval, addressing the randomized comparison directly. The p-value indicates incompatibility with a null difference under the test assumptions, while the estimate and interval communicate the magnitude and precision of the contrast.
The study's follow-up structure is another useful feature to interpret carefully. The initial placebo-controlled period is followed by an open-label period in which both groups receive risedronate. A longer observation period does not automatically preserve a randomized comparison of the original treatments. The treatment contrast and question being answered depend on the period and design.
Finally, the record highlights limits of registry summaries. The primary analysis is described, but details of missing data, multiplicity, the sample-size rationale, and full statistical modeling are not reported. Those gaps do not erase the posted primary result, but they frame how much can be concluded from it. Careful statistical interpretation distinguishes a precise estimate for the measured outcome from claims about outcomes or analyses not reported in the record.
15. 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 endpoint concerns lumbar spine bone mineral density rather than a clinical event. The registry record does not report a primary fracture outcome, so the posted difference should not be translated into a claim about fracture rates. It also does not report the clinical importance threshold, if any, for the observed change.
Although the primary population is identified as intention to treat with last observation carried forward, the record does not state the amount or pattern of missing endpoint data, the reasons for missingness, or results from alternative missing-data analyses. This limits assessment of how robust the estimate is to the handling of unobserved measurements.
The registry identifies ANOVA for the sponsor-reported comparison but does not describe the full model specification or any additional covariates. Randomization and double masking are recorded, but allocation concealment and detailed participant flow are not reported in the registry record. The analysis counts differ from the overall enrollment, and the record does not explain that difference.
The study had an open-label phase after the randomized 2-year comparison, during which both groups received risedronate. As a result, longer-term observations do not preserve the original placebo comparison. The registry also does not report a multiplicity strategy for the many secondary outcomes, so their statistical significance should be interpreted cautiously.
For safety, the registry lists serious-event counts in separate periods and serious-event terms, but it does not provide the denominator and method for the term percentages in the record. These summaries alone cannot establish treatment causality. The record does not report the original sample-size justification, interim analyses, or a complete statistical plan.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis — NCT00619957.
- Registry record last updated 2011-10-28; status last verified 2011-09.
- Results first posted 2011-10-28.
- 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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19. Record Summary
NCT00619957 is a completed, randomized, double-blind, parallel-group phase 3 study sponsored by Warner Chilcott. It enrolled 285 men with osteoporosis. The recorded study start was 2002-06, and primary completion was 2007-05. The design compared weekly 35 mg risedronate with placebo for 2 years, followed by an open-label period in which both groups received weekly risedronate for 2 years.
The primary outcome was percent change from baseline in lumbar spine bone mineral density at 24 months or endpoint, analyzed in the intention-to-treat population with last observation carried forward. The sponsor-reported ANOVA difference was 4.53, with a 95% confidence interval from 3.46 to 5.60 and p < 0.001. Secondary outcomes covered additional bone mineral density measures and a responder outcome. The record does not report a multiplicity strategy, the trial's sample-size justification, or detailed missing-data sensitivity analyses.