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 A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. (NCT00503113), a randomized phase 4 study. The primary outcome is Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00503113 |
| Phase | Phase 4 |
| Condition | Post-Menopausal Osteoporosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 801 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women with osteoporosis who were considered at increased risk of renal disease. The registry record describes a Per Protocol population for the primary endpoint, but does not report additional eligibility details or the number of participants included in that analysis.
Intervention
Intravenous ibandronate, given as a 3 mg injection or a 3 mg infusion once every 3 months. The brief summary describes anticipated treatment duration as 3-12 months.
Comparator
Oral alendronate 70 mg, taken weekly. The study was randomized and open label, with parallel groups.
Primary question
What was the change from baseline in actual glomerular filtration rate after 9 months, or 40 weeks, of treatment, measured using the abbreviated MDRD formula and patients’ actual body surface area? The registry record identifies this as the primary endpoint but does not report its numerical results.
The clinical question concerns renal function during treatment with these osteoporosis medicines in a population described as being at increased risk of renal disease. It compares two intravenous ibandronate administration methods with oral alendronate; it is not a comparison of ibandronate with no treatment. The study also listed secondary measures involving glomerular filtration rate calculated with other formulas, serum creatinine, and the urine albumin-to-creatinine ratio. Those measures provide additional ways to describe renal function, but the primary question is specifically about absolute change in actual GFR using the abbreviated MDRD formula.
The registry record does not provide the primary outcome values, group estimates, or a statistical comparison. Consequently, it does not establish from the posted results whether the groups differed in the measured endpoint, or how precisely any difference was estimated. The focus is the trial question, its design, and what can and cannot be inferred from the recorded information.
3. Trial Design
This was a randomized, open-label, parallel-group Phase 4 study. The registry record lists 801 participants enrolled and describes three treatment groups: ibandronate 3 mg by intravenous injection, ibandronate 3 mg by intravenous infusion, and alendronate 70 mg orally. The brief summary states that ibandronate was scheduled once every 3 months and alendronate weekly. Treatment was anticipated to continue for 3-12 months.
Random allocation is intended to assign treatment groups through a chance process, which can reduce systematic differences between groups at the outset. Randomization does not guarantee that all characteristics will be identical, and its value depends on implementation and the analysis. Details of the randomization procedure, including how the sequence was generated or concealed, are not reported in the registry record. The study is described as open label, with no masking. The registry record therefore does not indicate that participants or study personnel were blinded to assigned treatment.
The primary endpoint was defined as absolute change from baseline in actual GFR, using the abbreviated MDRD formula and the participants’ actual body surface area. The stated timeframe was baseline and 9 months; the endpoint description also refers to 9 months or 40 weeks of treatment. The primary analysis population is identified as Per Protocol. The number of participants in that population, and the criteria for inclusion in it, are not reported in the registry record.
The record lists a start date of 2007-07, primary completion in 2010-04, and a completed status. These dates describe the registered study timeline, not the duration of treatment for each participant. The planned target sample size in the brief summary is 500+ individuals, whereas the enrollment field records 801. The rationale for the target size, any revisions, and the relationship between planned and enrolled numbers are not reported. No detailed protocol, allocation ratios, or analysis plan is 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.
Before assignment: Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.
Overall Study
| Stage | Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral |
|---|---|---|---|
| STARTED | 268 | 264 | 269 |
| Intent to Treat Population (ITT) | 262 | 261 | 268 |
| Per Protocol Population (PP) | 246 | 243 | 241 |
| Safety Population | 263 | 263 | 267 |
| COMPLETED | 235 | 236 | 241 |
| NOT COMPLETED | 33 | 28 | 28 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol (PP) Population
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 | Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral | Total |
|---|---|---|---|---|---|
| Participants analysed | 263 | 263 | 267 | 793 | |
| Age Continuous | years | 71.7 (SD 6.77) | 71.5 (SD 5.89) | 71.7 (SD 6.3) | 71.6 (SD 6.32) |
| Sex: Female, Male: Female | Participants | 263 | 263 | 267 | 793 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula), measured over Baseline and 9 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL/min |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the absolute change from baseline in actual glomerular filtration rate, expressed in mL/min. GFR is used as a measure of kidney filtration function. In this study it was calculated with the abbreviated Modification of Diet in Renal Disease formula, using each patient’s actual body surface area. The registry describes measurement at baseline and 9 months, also expressed as 40 weeks of treatment.
Change from baseline focuses on how a participant’s measured value changes over follow-up rather than relying only on a single follow-up measurement. A group mean change can describe the average direction and magnitude of change among the participants included in the analysis. It does not show how much participants varied around that average; the endpoint specifies standard deviation as its dispersion measure, which would describe that variability if results were posted.
GFR is relevant to the stated renal-safety question because it is a measure of filtration function. It is an estimate based on a formula, not a direct measurement of every aspect of kidney health. The choice of formula and the use of actual body surface area are part of the endpoint definition and should be kept in mind when interpreting results. The registry record lists secondary GFR measures using Cockcroft-Gault and abbreviated MDRD approaches, along with serum creatinine and urine albumin-to-creatinine ratio measures. These are distinct outcomes and should not be treated as interchangeable with the primary endpoint.
The primary endpoint’s numerical values, variability estimates, and between-group comparisons are not reported in the registry record. Thus, the endpoint is defined, but its observed magnitude and precision cannot be assessed from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a specific primary outcome, population, and timeframe, but does not report the primary outcome results. There are no posted group means for change in GFR, standard deviations, confidence intervals, or tests of between-group differences in the information available for this analysis. Without those results, the study’s central renal-function comparison cannot be quantified. It is not possible to determine from the registry record how large any observed changes were, how variable they were, or whether the groups were distinguishable statistically.
The distinction between a study question and a result is important. A defined endpoint tells readers what investigators intended to measure; it does not establish what the measurements showed. Similarly, enrollment and completion status do not supply evidence about the direction or size of an endpoint effect. The study’s posted information therefore supports describing the design and outcome definition, but not drawing a conclusion about comparative renal function.
The primary endpoint is a continuous measure. In general, an estimated mean change describes an average among the people included in an analysis, while its standard deviation describes participant-to-participant variation around that mean. A comparison between groups would need to identify the groups being compared, the estimated difference in their mean changes, and uncertainty around that estimate. A confidence interval is a range of values compatible with the data and analysis under the method’s assumptions; its width conveys precision. None of these primary-result quantities is reported in the registry record.
The study’s open-label status is relevant when considering outcomes and conduct, although the endpoint is a laboratory-derived estimate rather than a subjective rating. Open-label knowledge can still affect participant behavior, follow-up, co-interventions, or decisions about continued participation. Randomization helps address baseline confounding in expectation, but it cannot correct every source of bias, and it does not replace clear reporting of the analysis population and missing observations. Details needed to assess those issues are not reported in the registry record.
The adverse-event information is descriptive. The registry lists numbers of participants at risk and affected for serious and other adverse events in each group, as well as selected serious-event terms and percentages. Those figures can be read as counts within the recorded group denominators, but they do not on their own establish comparative risk. No adjusted comparisons or uncertainty estimates for these safety counts are reported. The deaths fields are not populated with a number, so deaths are not reported in the registry record.
Planning illustrations based on an observed effect, where presented, are not observed trial outcomes and are not observed power. Their interpretation depends on the effect assumed for planning and the stated statistical assumptions. The registry record does not report a sample-size justification or the trial’s own detailed power calculation. Such illustrations cannot fill the gap left by absent primary endpoint estimates.
Overall, the record makes the study’s intended comparison and measurement clear, but the missing primary results prevent a statistical assessment of the principal question. This is a limitation of the available reporting, not evidence that the groups had equal or different outcomes.
9. Statistical Methods Explained
The endpoint is a continuous outcome: a numeric measurement that can take a range of values. The primary parameter is the mean change in GFR from baseline. A mean is useful for describing the average change across an analysis population, but it is not a description of every participant’s course. Two groups can have similar means while differing in the spread or pattern of individual values. The registry specifies standard deviation as the measure of dispersion, but does not post the primary endpoint estimates or their standard deviations.
What does change from baseline represent?
For each participant, change from baseline represents the follow-up value relative to that participant’s starting value. Summarizing these changes by a group mean provides an average change over the specified period. A comparison between randomized groups could then focus on the difference between their average changes. In general, the estimated group contrast is more directly informative about the comparative question than considering whether one group’s change is statistically distinguishable from zero while another’s is not. The registry record does not report the estimated contrast or its uncertainty.
The endpoint timeframe is baseline and 9 months, also described as 40 weeks. The endpoint description calls for measurement after 9 months or 40 weeks of treatment. A defined follow-up point matters because change is time-dependent: estimates from different measurement times would answer different questions. The registry record does not report the actual timing distribution of measurements or how measurements outside the stated timeframe were handled.
Why is GFR an estimate?
Glomerular filtration rate represents kidney filtration function. The primary outcome uses the abbreviated MDRD formula and the participants’ actual body surface area to calculate actual GFR, reported in mL/min. A formula-based estimate depends on the inputs and formula chosen, so estimates from different formulas may not be identical. The listed secondary outcomes include GFR measures using Cockcroft-Gault and abbreviated MDRD formulas. Those outcomes should be interpreted according to their own definitions rather than combined with the primary measure. The registry record does not provide the calculation details beyond the formula and body-surface-area description.
Serum creatinine and urine albumin-to-creatinine ratio are also listed as secondary outcomes. They represent different measurements from calculated GFR. Looking at several renal measures can describe different aspects of renal status, but results for one measure cannot be substituted for results on another. Numerical results for these secondary outcomes are not reported in the registry record.
How should uncertainty be considered?
In general, an estimate from a sample is uncertain because another sample could yield a different estimate. A confidence interval expresses that uncertainty as a range, conditional on the statistical model and assumptions used. A narrow interval indicates greater precision than a wide interval, while the interval’s location indicates which effect values remain compatible with the data and method. A p-value, when reported, describes how surprising data at least as extreme as those observed would be under a specified null model; it is not the probability that a treatment effect is true. Neither confidence intervals nor p-values for the primary comparison are reported in the registry record.
Standard deviation and standard error serve different purposes. Standard deviation describes variation among observations, whereas standard error describes uncertainty in an estimate such as a mean. The primary endpoint specifies standard deviation, but the posted record does not give its numerical value. It also does not provide the primary analysis model, standard errors, or confidence intervals. A reader therefore cannot reconstruct precision or use a standard deviation to infer a treatment comparison.
What does randomization contribute?
In general, random allocation is designed to make treatment assignment independent of participants’ measured and unmeasured baseline characteristics on average. This supports causal comparison when allocation is implemented appropriately and participants are analyzed in a way consistent with the randomized groups. Randomization does not ensure exact balance, prevent missing follow-up, or protect against bias introduced after assignment. The registry identifies the study as randomized but does not report the sequence-generation or concealment procedures, the allocation ratio, or a detailed analysis plan.
The trial is parallel group: participants are assigned to a treatment group and followed under that assignment rather than crossing through all treatment options. It is also open label, with masking listed as none. In general, lack of masking may influence behaviors or decisions during a study. The extent of any such influence cannot be assessed from the registry information. The primary outcome is a formula-based measure, but interpretation still depends on how measurements were collected, processed, and analyzed.
How do planning calculations differ from results?
General sample-size planning uses assumptions about the effect to detect, variability, significance level, allocation, and statistical method. The registry record states that planning illustrations were computed from the observed effect using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the intended effect is a stated fraction of the observed effect. These are planning assumptions, not trial outcomes. Participants per arm for 80% power, when included as a planning illustration, describe a hypothetical design under those assumptions; they are not the number observed in the trial and do not constitute observed power.
The record’s planning description does not establish that the trial itself was designed using those assumptions. Its own sample-size justification, target effect, variability assumptions, and any recalculation or revision are not reported in the registry record. Since the primary outcome results are not reported, a planning exercise based on an observed effect cannot be independently interpreted from the available record. It should not be treated as evidence for or against a treatment difference.
What information would support a full statistical reading?
A fuller assessment would require the group-level primary endpoint estimates, dispersion, treatment contrasts, confidence intervals, and the analysis population counts. It would also require the planned statistical model, how missing measurements were handled, and whether analyses followed the randomized assignment or were restricted to protocol-adherent participants. These details matter because the primary outcome is reported for a Per Protocol population, while the study itself was randomized. The registry record does not report these additional details. Their absence limits assessment of both the size and reliability of any comparative result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures, including the primary GFR endpoint and secondary measures involving GFR, serum creatinine, and urine albumin-to-creatinine ratio. Considering several outcomes creates a multiplicity issue: when many statistical tests are conducted, the chance of at least one apparently unusual result can increase. In general, investigators may define a primary outcome in advance, adjust for multiple testing, or treat secondary analyses as exploratory. The registry record does not report a multiplicity strategy, the order of testing, or whether any adjustment was used. It also does not provide numerical results for the listed outcomes.
The primary outcome is identified for the Per Protocol population. The number of participants analyzed, the criteria defining that population, and how participants who did not follow the assigned regimen were treated in the analysis are not reported in the registry record. A Per Protocol analysis can describe outcomes among participants meeting protocol criteria, but the criteria and exclusions are necessary to understand who contributed to the estimate. The registry record does not report an intention-to-treat analysis or explain whether one was conducted.
Missing outcome data can affect both precision and validity. In general, complete-case analysis, imputation, and model-based approaches make different assumptions about missingness. The appropriate interpretation depends on the amount, timing, and reasons for missing data, as well as the method used. The registry record does not report missing-data counts, reasons for missingness, or a missing-data method. It is therefore not possible to assess whether missing observations could have altered the primary comparison.
There are no analyses listed in the registry record. The detailed statistical plan, interim analyses, and handling of protocol deviations are not reported in the registry record. These omissions do not establish that such procedures were absent; they mean that the record does not describe them.
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 |
|---|---|---|---|
| Ibandronate 3 mg Injection | 19 | 263 | 7.2% |
| Ibandronate 3 mg Infusion | 15 | 263 | 5.7% |
| Alendronate 70 mg Oral | 13 | 267 | 4.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2.0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ibandronate 3 mg Injection | 196 of 263 |
| Ibandronate 3 mg Infusion | 190 of 263 |
| Alendronate 70 mg Oral | 191 of 267 |
Most frequent serious adverse event terms
| Event term | Organ system | Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral |
|---|---|---|---|---|
| Femur Fracture | Injury, poisoning and procedural complications | 3 of 263 | 1 of 263 | 4 of 267 |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | 3 of 263 | 1 of 263 | 1 of 267 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 2 of 263 | 0 of 263 | 2 of 267 |
| Pneumonia | Infections and infestations | 1 of 263 | 1 of 263 | 1 of 267 |
| Atrial Fibrillation | Cardiac disorders | 1 of 263 | 1 of 263 | 0 of 267 |
| Cardiac Failure Congestive | Cardiac disorders | 2 of 263 | 0 of 263 | 0 of 267 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 263 | 1 of 263 | 0 of 267 |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 263 | 0 of 263 | 0 of 267 |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | 0 of 263 | 1 of 263 | 1 of 267 |
| Cholecystitis | Hepatobiliary disorders | 0 of 263 | 1 of 263 | 1 of 267 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral |
|---|---|---|---|---|
| Influenza | Infections and infestations | 37 of 263 | 32 of 263 | 30 of 267 |
| Back Pain | Musculoskeletal and connective tissue disorders | 26 of 263 | 29 of 263 | 25 of 267 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22 of 263 | 28 of 263 | 27 of 267 |
| Hypertension | Vascular disorders | 23 of 263 | 28 of 263 | 16 of 267 |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | 22 of 263 | 23 of 263 | 21 of 267 |
| Myalgia | Musculoskeletal and connective tissue disorders | 22 of 263 | 14 of 263 | 6 of 267 |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 19 of 263 | 15 of 263 | 7 of 267 |
| Dizziness | Nervous system disorders | 19 of 263 | 12 of 263 | 9 of 267 |
| Diarrhoea | Gastrointestinal disorders | 7 of 263 | 11 of 263 | 19 of 267 |
| Cough | Respiratory, thoracic and mediastinal disorders | 14 of 263 | 5 of 263 | 17 of 267 |
Serious events with the highest arm-level rate: femur fracture (1.5%), femoral neck fracture (1.1%), cardiac failure congestive (0.8%), osteoarthritis (0.8%), breast cancer (0.8%).
The registry lists serious adverse events and other adverse events separately for the three treatment groups. For serious adverse events, the recorded numbers of participants at risk and affected are 263 and 19 for ibandronate 3 mg injection, 263 and 15 for ibandronate 3 mg infusion, and 267 and 13 for alendronate 70 mg oral. For other adverse events, the corresponding at-risk and affected counts are 263 and 196, 263 and 190, and 267 and 191. These are descriptive counts, not adjusted comparisons.
The listed serious-event terms include Femur Fracture at 1.5%, Femoral Neck Fracture at 1.1%, Cardiac Failure Congestive at 0.8%, Osteoarthritis at 0.8%, Breast Cancer at 0.8%, and Fall at 0.4%. These are the reported percentages for the selected terms; the registry record does not provide group-specific rates for each term in this listing. The terms should not be interpreted as proof that a treatment caused an event.
Counts of affected participants do not convey event timing, recurrence, severity within the non-serious category, or uncertainty around group differences. The record does not report statistical comparisons for these safety counts. Deaths are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, open-label study was conducted to compare two intravenous ibandronate administration methods with oral alendronate in postmenopausal women with osteoporosis at increased risk of renal disease. It defines the primary renal-function endpoint as absolute change in actual GFR from baseline to 9 months, using the abbreviated MDRD formula and actual body surface area. It also reports enrollment and selected adverse-event counts.
Those details do not answer whether the treatments differed in the primary outcome. The primary numerical results, group estimates, and uncertainty measures are not reported in the registry record. Therefore, the record does not support a quantitative conclusion about the direction or magnitude of changes in GFR, the size of any between-group difference, or its precision. It also does not support concluding that the groups were equivalent simply because an estimate or test result is unavailable.
The adverse-event counts describe events recorded in each group, but they do not by themselves show whether differences between groups are attributable to treatment. The record does not provide adjusted safety comparisons or uncertainty estimates, and deaths are not reported in the registry record. A count within a group is informative as a descriptive record, but interpretation as comparative evidence requires attention to denominators, follow-up, event definitions, and analytic methods.
More broadly, a registered endpoint is not itself evidence of a favorable or unfavorable outcome. Randomization and the study’s design provide a framework for comparative inference, but the inference depends on the results and methods being reported. The primary analysis population is identified as Per Protocol, while its size and criteria are not reported. Missing-data handling and detailed statistical methods are also not reported. These gaps prevent a complete assessment of representativeness, bias, and precision.
The appropriate reading is therefore limited but clear: the study set out to examine renal function under the specified treatments, and the registry records the design and some safety counts. The posted information does not permit a statistical conclusion about the primary renal-function comparison or a causal conclusion about the listed adverse events.
13. Why This Trial Matters Statistically
This study is statistically notable because it frames a renal-safety question around a defined continuous endpoint and a randomized comparison of three active treatment groups. The primary measure is not a general label such as “kidney safety”; it is a specified change in actual GFR, calculated with a named formula and evaluated at a stated follow-up. That precision in defining an endpoint is important: it clarifies what an analysis would estimate and makes clear that results from other renal measures would answer related, but different, questions.
The two ibandronate groups distinguish injection from infusion, while the oral alendronate group provides an active comparator. This structure raises multiple possible pairwise questions. The registry record does not report which comparisons were prespecified, how they were ordered, or whether multiplicity was addressed. Without a reported analysis plan and primary estimates, readers cannot establish which contrasts were intended to carry the principal interpretation or assess the uncertainty of those contrasts.
The trial also illustrates why enrollment alone is not enough to evaluate evidence. Although the registry records 801 enrolled participants, the primary outcome is specified for a Per Protocol population and the analyzed population size is not reported. The extent of missing data, the handling of deviations, and the details of the statistical model are also not reported. These aspects determine how the enrolled study population connects to the analysis that would answer the clinical question.
Finally, this record demonstrates the difference between an endpoint definition and a reportable result. The primary outcome is described in detail, but its numerical findings are not reported in the registry record. In statistical terms, the estimand is more clearly specified than its estimate. This distinction matters to readers assessing what the trial can establish: design features describe the intended comparison, while estimates and uncertainty are needed to judge its observed results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is that primary outcome results are not reported in the registry record. There are no group-specific mean changes, standard deviations, estimated contrasts, confidence intervals, or p-values for the primary endpoint. As a result, the principal comparative question cannot be answered quantitatively from the posted information.
The endpoint is described for a Per Protocol population, but the record does not state how many participants were included or what criteria defined that population. It does not report the number of participants with measurements at baseline and follow-up, or explain how protocol deviations and missing observations were handled. These omissions limit the ability to assess selection effects and the reliability of the analysis population.
Although the study is identified as randomized, the registry record does not describe sequence generation, allocation concealment, or allocation ratios. The open-label design is reported, but there is no detail about whether knowledge of assignment affected measurement procedures, follow-up, or decisions about continued participation. The record also does not report the statistical analysis plan, multiplicity procedures, or interim analyses.
The record lists several secondary renal measures, but does not report their results or explain how they were intended to complement the primary endpoint. The adverse-event summary provides selected counts and terms, but not adjusted comparisons, uncertainty estimates, event timing, or complete event-level detail. Deaths are not reported in the registry record.
The brief summary gives an anticipated treatment duration of 3-12 months, while the primary endpoint is specified at 9 months or 40 weeks. The record does not describe how follow-up or treatment duration varied among participants, or how measurements at different times were handled. These limitations concern reporting available in the registry record; they should not be mistaken for proof that the underlying study lacked methods or analyses that were not described.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. — NCT00503113.
- Registry record last updated 2011-06-17; status last verified 2011-05.
- Results first posted 2011-06-17.
- 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
NCT00503113 is a completed randomized, open-label, parallel-group Phase 4 study sponsored by Hoffmann-La Roche. It enrolled 801 postmenopausal women with osteoporosis at increased risk of renal disease. Participants were assigned to ibandronate 3 mg by intravenous injection, ibandronate 3 mg by intravenous infusion, or oral alendronate 70 mg. The brief summary describes treatment once every 3 months for intravenous ibandronate and weekly for oral alendronate, with anticipated study treatment of 3-12 months.
The primary endpoint was absolute change from baseline in actual GFR using the abbreviated MDRD formula and actual body surface area, measured at baseline and 9 months or 40 weeks. The primary analysis population is identified as Per Protocol. Numerical primary results, analysis-population details, missing-data methods, and the statistical analysis plan are not reported in the registry record. Descriptive adverse-event counts are listed, but deaths are not reported in the registry record.