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 Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women (NCT00205777), a randomized phase 3 study. The primary outcome is Percentage of Participants With New Vertebral Fractures Through Month 36.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00205777 |
| Phase | Phase 3 |
| Condition | Osteoporosis |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Double |
| Enrollment | 7609 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women with osteoporosis. The registry record lists total enrollment as 7609. The primary-outcome population was narrower: participants randomized, given at least 1 dose of test article, and assessed by vertebral radiography at baseline and at least once while on therapy.
Intervention
Bazedoxifene acetate. The adverse-event groups are identified as Bazedoxifene 20 mg and Bazedoxifene 40/ 20 mg. The registry record does not describe the dosing details for the primary-outcome comparison.
Comparator
The official title names placebo and raloxifene as comparators. The intervention list names bazedoxifene acetate and placebo, while the adverse-event groups also include Raloxifene 60 mg (Core Study). The primary-outcome arm-specific results and comparison details are not reported in the registry record.
Primary question
What percentage of participants had a new vertebral fracture from baseline through Month 36? The registry defines the outcome and its analysis population, but does not report the outcome percentages or a treatment-effect estimate.
3. Trial Design
The registry describes a phase 3, randomized, double-masked study sponsored by Pfizer. It lists the condition as osteoporosis and the overall enrollment as 7609. The study status is completed. The recorded start is 2001-12, and primary completion is recorded as 2010-09.
The official title describes fracture incidence reduction and safety of bazedoxifene acetate compared with placebo and raloxifene in osteoporotic postmenopausal women. The brief summary likewise describes evaluating bazedoxifene acetate for safety and effectiveness in postmenopausal women with osteoporosis. The intervention list identifies bazedoxifene acetate and placebo. The adverse-event groups separately identify Bazedoxifene 20 mg, Bazedoxifene 40/ 20 mg, Raloxifene 60 mg (Core Study), and Placebo.
The registry records the study model as single group, despite also identifying the study as randomized and naming multiple treatments. The record does not explain this labeling or give arm descriptions; those descriptions are blank. Accordingly, the model label alone does not clarify how the treatment comparisons were organized or analyzed. The primary-outcome comparison details are not reported in the registry record.
The primary outcome covers baseline through Month 36. Secondary outcomes include breast cancer incidence and new clinical vertebral fractures through Month 36, Month 60, and Month 84, as well as worsening vertebral fractures through Month 36 and Month 60. The registry lists 60 outcome measures and 601 analyses. Those counts indicate a broad set of registered outcomes and analyses, but do not specify which results were available or how comparisons were selected for reporting.
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.
Core Study (Up to 3 Years)
| Stage | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| STARTED | 1907 | 1904 | 1884 | 1914 | 0 | 0 |
| TREATED | 1886 | 1872 | 1849 | 1885 | 0 | 0 |
| COMPLETED | 1279 | 1245 | 1277 | 1282 | 0 | 0 |
| NOT COMPLETED | 628 | 659 | 607 | 632 | 0 | 0 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| Adverse Event | 260 | 267 | 252 | 232 | 0 | 0 |
| Death | 9 | 7 | 14 | 7 | 0 | 0 |
| Failed to return | 40 | 25 | 27 | 27 | 0 | 0 |
| Other Event | 49 | 52 | 41 | 58 | 0 | 0 |
| Withdrawal by Subject | 144 | 169 | 149 | 162 | 0 | 0 |
| Protocol Violation | 53 | 55 | 50 | 42 | 0 | 0 |
| Lack of Efficacy | 52 | 52 | 39 | 75 | 0 | 0 |
| Randomized but not treated | 21 | 32 | 35 | 29 | 0 | 0 |
Completed Core Study, Entered SE I
| Stage | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| STARTED | 1279 | 1245 | 1277 | 1282 | 0 | 0 |
| COMPLETED | 1047 | 1041 | 1070 | 1058 | 0 | 0 |
| NOT COMPLETED | 232 | 204 | 207 | 224 | 0 | 0 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 180 | 158 | 160 | 174 | 0 | 0 |
| Other Event | 52 | 46 | 47 | 50 | 0 | 0 |
Study Extension I
| Stage | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| STARTED | 1047 | 0 | 1070 | 1058 | 1041 | 0 |
| COMPLETED | 833 | 0 | 0 | 830 | 840 | 0 |
| NOT COMPLETED | 214 | 0 | 1070 | 228 | 201 | 0 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| Adverse Event | 57 | 0 | 0 | 61 | 58 | 0 |
| Death | 5 | 0 | 0 | 1 | 2 | 0 |
| Withdrawal by Subject | 99 | 0 | 0 | 106 | 89 | 0 |
| Protocol Violation | 4 | 0 | 0 | 8 | 8 | 0 |
| Lack of Efficacy | 0 | 0 | 0 | 1 | 2 | 0 |
| Failed to return | 15 | 0 | 0 | 17 | 13 | 0 |
| Other Event | 34 | 0 | 0 | 34 | 29 | 0 |
| Withdrawn as per protocol | 0 | 0 | 1070 | 0 | 0 | 0 |
Completed SE I, Entered Extension SE II
| Stage | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| STARTED | 833 | 0 | 0 | 830 | 840 | 0 |
| COMPLETED | 560 | 0 | 0 | 590 | 582 | 0 |
| NOT COMPLETED | 273 | 0 | 0 | 240 | 258 | 0 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Bazedoxifene 40/20 mg (SE I) | Bazedoxifene 20 mg (SE II) |
|---|---|---|---|---|---|---|
| No-consent/eligible/SEII continuing site | 273 | 0 | 0 | 240 | 258 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.
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 | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1886 | 1872 | 1849 | 1885 | 7492 | |
| Age Continuous | years | 66.48 (SD 6.53) | 66.22 (SD 6.80) | 66.36 (SD 6.74) | 66.47 (SD 6.76) | 66.38 (SD 6.71) |
| Sex: Female, Male: Female | Participants | 1886 | 1872 | 1849 | 1885 | 7492 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Height | centimeter (cm) | 156.60 (SD 7.21) | 156.28 (SD 7.38) | 156.37 (SD 7.23) | 156.35 (SD 6.90) | 156.40 (SD 7.18) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With New Vertebral Fractures Through Month 36, measured over Baseline through Month 36.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with new vertebral fractures from baseline through Month 36. A new fracture was defined using vertebral height change: a decrease in anterior, mid, or posterior vertebral height of approximately 20% and 4 millimeter or more from baseline to the end of the study, confirmed by measurement of the involved vertebral body. A semi-quantitative grade change of 1 from baseline for a vertebra from T4 to L4 could also qualify, provided that vertebra was not fractured at baseline.
Each participant was counted only once, regardless of how many new vertebral fractures were diagnosed. This participant-level percentage describes how commonly the defined event occurred, rather than the total number of fractures. The registry specifies stratification by baseline fracture status, categorized as no prevalent fracture or at least 1 prevalent fracture.
A fracture endpoint is relevant to a study whose stated focus is osteoporosis and fracture incidence. The registry record gives the measurement definition and timeframe, but not the number of participants with events, the analyzed group denominators, arm-specific percentages, confidence intervals, or a treatment-effect estimate. The observed primary-outcome result is therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and the endpoint definition, but it does not report the primary endpoint result. It gives no arm-specific percentage of participants with new vertebral fractures through Month 36 and no estimate comparing bazedoxifene with placebo or raloxifene. Without those results, the size, direction, and precision of any treatment difference cannot be interpreted from the registry information.
The primary outcome is a binary participant-level measure: each eligible participant either met the fracture definition during the stated period or did not. The record says a participant was counted once even when multiple new fractures were diagnosed. This distinction matters when reading an event percentage: it represents participants affected, not the total count of fracture events.
The endpoint description identifies an analysis population based on randomization, receipt of at least 1 dose, and availability of vertebral radiographic assessments at baseline and at least once while on therapy. That description does not establish how many participants met these conditions. The number analyzed and the number with a fracture are not reported in the registry record. Nor does the record explain how missing radiographs or incomplete follow-up were handled.
The registry identifies a 95% Confidence Interval as the primary outcome's dispersion measure. A confidence interval expresses uncertainty around an estimate; its width depends on the information in the data and the analysis. Since neither the estimate nor its interval is reported, the precision of the primary-outcome finding cannot be assessed. The same limitation applies to statistical evidence for any treatment comparison: no primary-outcome test result is reported.
The record lists 60 outcome measures and 601 analyses. These counts make it important to know how outcomes and comparisons were selected and whether statistical methods accounted for multiple testing. The registry record does not report a multiplicity procedure, a detailed statistical analysis plan, or the results needed to evaluate such procedures. It also does not report interim analyses. These omissions do not show that a particular method was or was not used; they mean the relevant details are unavailable in the registry record.
The trial is marked completed, but completion status is not itself evidence about the endpoint result. The available information supports describing the study design, endpoint definition, and registered safety groups. It does not support a conclusion about the observed fracture percentages or the comparative effect of any treatment.
9. Statistical Methods Explained
The registry identifies the study as randomized and double-masked. In a randomized study, allocation is intended to reduce systematic differences between treatment groups at the point of assignment. Masking is intended to limit the influence of knowledge about assigned treatment on aspects such as participant reporting or outcome assessment. The registry does not describe the allocation sequence, concealment procedures, who was masked, or how masking was maintained.
What kind of outcome is the primary endpoint?
The endpoint is a percentage of participants who experienced a defined event. Statistically, this is a binary outcome at the participant level: the event is either recorded or not recorded for each person in the relevant analysis population. The definition is based on vertebral height changes or a specified semi-quantitative grade change, with restrictions for vertebrae already fractured at baseline. Each participant contributes once to the percentage, even if more than one new fracture was diagnosed.
For a binary outcome, the percentage is interpreted together with its denominator. The registry describes who was eligible for the vertebral-fracture analysis, but does not give the number analyzed in each group or the number with an event. It therefore does not allow the event percentages to be reconstructed or checked. The listed total enrollment of 7609 should not be assumed to be the denominator for this endpoint, because the endpoint population has additional assessment and treatment criteria.
What does the confidence interval convey?
The primary outcome lists a 95% Confidence Interval as its dispersion measure. In general, a confidence interval is a range of values compatible with the data and the statistical method used, expressing uncertainty around an estimated quantity. A narrow interval indicates greater precision than a wide interval, all else equal. Its interpretation depends on the estimand and method, including whether the interval concerns an event percentage or a contrast between groups. The registry record does not give the interval or identify the exact interval calculation.
A confidence interval for each group's event percentage would describe uncertainty in each percentage. A confidence interval for a between-group contrast would address uncertainty in the estimated difference or other comparison measure. These are not interchangeable. The registry's outcome description identifies the percentage and a confidence-interval dispersion measure, but does not specify whether a comparative effect estimate was also calculated or reported.
Why does the analysis population matter?
The endpoint population is described as randomized participants who took at least 1 dose of test article and had a vertebral radiographic assessment at baseline and at least once while on therapy. This is the registry's stated population for vertebral-fracture outcomes. It is not identical, by definition, to every person enrolled. Requiring an assessment after baseline can make the analyzed population depend on continued participation and measurement availability. That can affect interpretation if those with missing assessments differ from those assessed. The record does not report the number excluded, reasons for missing assessments, or methods for addressing missing data.
The endpoint description also says participants were stratified by baseline fracture status, with categories of no prevalent fracture and at least 1 prevalent fracture. Stratification accounts for a characteristic relevant to the analysis by considering these categories. The registry does not give the specific statistical model, the way the strata entered the analysis, or whether the reported outcome was adjusted for other characteristics.
How should randomization and the registry model label be read?
Randomization is recorded, and the official title names placebo and raloxifene comparators. However, the study model is labeled single group, arm descriptions are blank, and the intervention list names only bazedoxifene acetate and placebo. The adverse-event groups additionally include a raloxifene group. The registry does not explain the apparent mismatch among these fields. It is therefore not possible to infer the exact primary-outcome comparison structure from the model label or to resolve the discrepancy using the registry record alone.
What can be inferred from the listed analysis counts?
The registry lists 60 outcome measures and 601 analyses. When many outcomes or analyses are considered, the chance of finding apparently notable results by chance can increase if each is assessed separately without an appropriate strategy. Multiplicity methods can address this issue, depending on the questions and analysis plan. The number of listed analyses alone does not reveal which analyses were confirmatory, how they were related, or whether adjustment was used. Those details are not reported in the registry record.
The record does not report the model used for the primary outcome, the exact effect measure for comparisons, a p-value, or a detailed statistical analysis plan. It also does not report interim analyses or a sample-size justification. No such details should be inferred from the fact that the study was randomized or completed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 60 outcome measures and 601 analyses. With many outcomes and analyses, selective interpretation can be a concern, and multiplicity procedures may be used to control the chance of misleading findings across a family of tests. The registry record does not report which outcomes were designated as confirmatory, how tests were grouped, or whether any multiplicity adjustment was planned or applied. A detailed statistical analysis plan is not reported in the registry record.
The primary outcome's stated population consists of randomized participants who took at least 1 dose of test article and had a vertebral radiographic assessment at baseline and at least once while on therapy. The record does not give the number of participants meeting these criteria, the number with missing assessments, or the reasons data were unavailable. It does not report the method used to handle missing radiographs or follow-up, or whether any sensitivity analyses examined the impact of missing data.
The record does not report an interim-analysis plan, stopping rules, or a sample-size justification. A planning illustration based on an observed effect is not the same as the trial's original design justification, and any sample-size illustration should not be read as observed power. The registry does not provide the primary-outcome result needed to assess an observed effect in this study.
The eligibility description, missing-data handling, and analysis plan all affect interpretation of a treatment comparison. The registry record permits a description of the stated endpoint population, but does not provide enough detail to determine how incomplete outcome data or multiple analyses were handled.
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 |
|---|---|---|---|
| Bazedoxifene 20 mg | 507 | 1886 | 26.9% |
| Bazedoxifene 40/ 20 mg | 468 | 1872 | 25.0% |
| Raloxifene 60 mg (Core Study) | 393 | 1849 | 21.3% |
| Placebo | 479 | 1885 | 25.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bazedoxifene 20 mg | 1818 of 1886 |
| Bazedoxifene 40/ 20 mg | 1800 of 1872 |
| Raloxifene 60 mg (Core Study) | 1775 of 1849 |
| Placebo | 1823 of 1885 |
Most frequent serious adverse event terms
| Event term | Organ system | Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo |
|---|---|---|---|---|---|
| Accidental injury | General disorders | 65 of 1886 | 50 of 1872 | 55 of 1849 | 61 of 1885 |
| Arthrosis | Musculoskeletal and connective tissue disorders | 26 of 1886 | 25 of 1872 | 22 of 1849 | 23 of 1885 |
| Cholelithiasis | Gastrointestinal disorders | 21 of 1886 | 23 of 1872 | 13 of 1849 | 31 of 1885 |
| Skin carcinoma | Skin and subcutaneous tissue disorders | 18 of 1886 | 33 of 1872 | 14 of 1849 | 23 of 1885 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 21 of 1886 | 19 of 1872 | 15 of 1849 | 23 of 1885 |
| Cerebrovascular accident | Cardiac disorders | 14 of 1886 | 17 of 1872 | 10 of 1849 | 18 of 1885 |
| Hypertension | Cardiac disorders | 13 of 1886 | 8 of 1872 | 18 of 1849 | 17 of 1885 |
| Gastrointestinal carcinoma | Gastrointestinal disorders | 15 of 1886 | 13 of 1872 | 11 of 1849 | 17 of 1885 |
| Breast carcinoma | Renal and urinary disorders | 14 of 1886 | 9 of 1872 | 9 of 1849 | 11 of 1885 |
| Cholecystitis | Gastrointestinal disorders | 12 of 1886 | 12 of 1872 | 6 of 1849 | 11 of 1885 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bazedoxifene 20 mg | Bazedoxifene 40/ 20 mg | Raloxifene 60 mg (Core Study) | Placebo |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 679 of 1886 | 660 of 1872 | 643 of 1849 | 662 of 1885 |
| Back pain | General disorders | 676 of 1886 | 652 of 1872 | 632 of 1849 | 674 of 1885 |
| Pain | General disorders | 643 of 1886 | 616 of 1872 | 615 of 1849 | 659 of 1885 |
| Flu syndrome | General disorders | 536 of 1886 | 523 of 1872 | 529 of 1849 | 559 of 1885 |
| Infection | General disorders | 526 of 1886 | 514 of 1872 | 462 of 1849 | 516 of 1885 |
| Abdominal pain | General disorders | 460 of 1886 | 460 of 1872 | 460 of 1849 | 509 of 1885 |
| Accidental injury | General disorders | 503 of 1886 | 449 of 1872 | 406 of 1849 | 522 of 1885 |
| Hypertension | Cardiac disorders | 495 of 1886 | 482 of 1872 | 412 of 1849 | 475 of 1885 |
| Headache | General disorders | 469 of 1886 | 468 of 1872 | 427 of 1849 | 471 of 1885 |
| Constipation | Gastrointestinal disorders | 383 of 1886 | 373 of 1872 | 344 of 1849 | 358 of 1885 |
Serious events with the highest arm-level rate: accidental injury (3.4%), skin carcinoma (1.8%), cholelithiasis (1.6%), arthrosis (1.4%), pneumonia (1.2%).
The registry lists four adverse-event groups: Bazedoxifene 20 mg, Bazedoxifene 40/ 20 mg, Raloxifene 60 mg (Core Study), and Placebo. For serious adverse events, it reports 507 affected among 1886 at risk for Bazedoxifene 20 mg; 468 among 1872 for Bazedoxifene 40/ 20 mg; 393 among 1849 for Raloxifene 60 mg (Core Study); and 479 among 1885 for Placebo.
These figures are counts of participants affected and at risk, not event rates calculated for a new comparison. They should be read in the context of each group's reported denominator. The registry record does not describe the serious-event definition, exposure duration by group, statistical comparisons, or whether the groups were otherwise comparable for these safety analyses. It also does not report death counts.
The listed serious adverse-event terms include Accidental injury, 3.4%; Skin carcinoma, 1.8%; Cholelithiasis, 1.6%; Arthrosis, 1.4%; Pneumonia, 1.2%; and Hypertension, 1.0%. The record does not specify in this listing which treatment groups these percentages cover or provide comparative estimates for these terms. These figures alone do not establish whether an event was caused by a treatment.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed, randomized, double-masked phase 3 study in postmenopausal women with osteoporosis, with new vertebral fractures through Month 36 designated as the primary outcome. It provides a detailed fracture definition, a stated analysis-population description, and several safety-group counts. These details help clarify what the study was intended to measure and how some participants were counted.
The record does not report the primary-outcome percentages, group denominators for that endpoint, confidence interval, or comparative treatment estimate. As a result, the posted information does not establish the direction or magnitude of a difference in new vertebral fractures among treatment groups. It also does not permit assessment of the precision of a primary-outcome estimate or the strength of statistical evidence for a comparison.
The listed serious adverse-event counts and selected event-term percentages are descriptive figures. Without definitions, fuller exposure information, and comparative analyses, they do not establish causal relationships or provide a complete account of comparative safety. The registry also does not report deaths in the adverse-event listing.
These limitations should not be mistaken for evidence that an analysis was not performed. They describe what is and is not reported in the registry record. Trial completion and a large enrollment do not substitute for outcome estimates, uncertainty intervals, or an analysis plan. The results available in the record support a description of the trial and its recorded outcomes, but not a conclusion that a treatment did or did not reduce fractures or alter safety outcomes.
13. Why This Trial Matters Statistically
This study illustrates why endpoint definitions and analysis populations matter when interpreting clinical-trial results. “New vertebral fracture” is not left as an unspecified clinical label: the registry describes vertebral height thresholds, confirmation, a semi-quantitative grading criterion, the eligible vertebral range, and how baseline fractures affect eligibility. It also specifies that a participant is counted once, rather than once for every diagnosed fracture. Those choices define the event whose percentage is being estimated.
The population definition is equally important. The vertebral-fracture analysis includes randomized participants who took at least 1 dose and had radiographic assessment at baseline and at least once while on therapy. That is more specific than the overall enrollment figure. Understanding the resulting estimate would require knowing how many participants met these conditions and how unavailable assessments were addressed; those details are not reported in the registry record.
The record also illustrates the distinction between a trial's stated design and the completeness of its posted statistical results. Randomization and double masking are recorded, but the model is labeled single group, arm descriptions are blank, and the treatment lists vary across sections. The primary-outcome result and detailed analysis plan are not reported. These discrepancies make it especially important not to infer the exact comparison or its findings from a title alone.
Finally, the registry lists 60 outcome measures and 601 analyses. In a study with numerous outcomes and analyses, a reader needs to know how the primary question was protected from selective interpretation and how multiplicity was handled. Those methods are not reported. Thus, the study is statistically informative as an example of endpoint specification and reporting needs, while the registry record does not provide the outcome estimates required to judge the primary comparison.
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 main limitation for interpreting efficacy is that the registry record does not report the primary outcome values. It identifies new vertebral fractures through Month 36 as the primary endpoint and describes how the event was defined, but gives no event counts, analyzed denominators, percentages, confidence interval, or treatment contrast. The comparative fracture result cannot be evaluated from this record.
The record's design fields are not fully aligned. Randomization and double masking are reported, while the study model is labeled single group. The official title names placebo and raloxifene comparators, the intervention list names bazedoxifene acetate and placebo, and the adverse-event groups include a raloxifene group. Arm descriptions are blank. The registry does not explain how these details relate to the primary-outcome analysis.
The primary-outcome population depends on taking at least 1 dose and having radiographic assessments at baseline and at least once while on therapy. The number of participants meeting those conditions and the handling of missing assessments are not reported in the registry record. The outcome description also does not provide enough detail to identify the statistical model or the method used to calculate the stated 95% Confidence Interval.
Although 60 outcome measures and 601 analyses are listed, the record does not report a detailed statistical analysis plan or multiplicity strategy. It also does not report interim analyses or the trial's sample-size justification. For safety, the registry gives group counts and selected serious-event percentages but does not report deaths, comparative estimates, or enough context to determine how the selected percentages were defined across groups. These reporting gaps limit both efficacy and safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women — NCT00205777.
- Registry record last updated 2013-04-10; status last verified 2013-02.
- Results first posted 2013-04-10.
- 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
NCT00205777 is a completed phase 3 study of bazedoxifene acetate in postmenopausal women with osteoporosis, sponsored by Pfizer. The registry records a randomized, double-masked design, enrollment of 7609, a start of 2001-12, and primary completion at 2010-09. Its official title names placebo and raloxifene comparators.
The primary outcome is the percentage of participants with new vertebral fractures through Month 36, with a detailed radiographic and grading definition. The record describes the endpoint population and lists a 95% Confidence Interval as the dispersion measure, but does not report the primary result or its comparative estimate. It lists 60 outcome measures and 601 analyses; multiplicity and missing-data methods are not reported in the registry record.
Safety groups include two bazedoxifene groups, raloxifene, and placebo, with serious adverse-event counts and selected event-term percentages. The record does not report deaths or a comparative safety analysis.