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 Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis (NCT00523341), a na phase 3 study. The primary outcome is Number of Participants With Adverse Events (AEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00523341 |
| Phase | Phase 3 |
| Condition | Osteopenia, Osteoporosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4550 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Amgen |
| Results posted | Yes |
2. Clinical Question
Population
Participants with osteopenia or osteoporosis entered an extension study after previously receiving denosumab or placebo. The primary endpoint population is described as all participants who received at least one dose of denosumab. The study title specifies postmenopausal osteoporosis, and the registry lists enrollment of 4550.
Intervention
Participants received denosumab, a biological intervention. The listed regimen was a 60 mg subcutaneous injection every 6 months for seven years. The extension was open label, so masking was none.
Comparator
There was no concurrent control group in the extension. The two recorded groups are titled “Placebo/ Denosumab 60 mg Q6M” and “Denosumab/ Denosumab 60 mg Q6M.” These labels describe treatment sequences, not a randomized comparison within this extension.
Primary question
The primary objective was to describe safety and tolerability during denosumab administration, using adverse-event monitoring, immunogenicity, and safety laboratory parameters. The primary outcome is the number of participants with adverse events over 84 months. The registry description includes serious events, treatment-related events, and specified events of interest.
3. Trial Design
This was a completed phase 3, open-label, single-group extension study of denosumab in postmenopausal osteoporosis. The registry identifies the allocation as not applicable and masking as none. These design features matter for interpretation: the extension does not assign participants to concurrent treatment groups for a randomized comparison, and participants and investigators were not masked to treatment.
The registry lists enrollment of 4550. The study started on 2007-08-07 and reached primary completion on 2015-07-19. The named intervention was denosumab. Participants received a 60 mg subcutaneous injection every 6 months for seven years. The primary objective description refers to safety and tolerability during up to 10 years or 7 years of denosumab administration in participants who previously received denosumab or placebo, respectively. The registry does not explain further how those durations relate to individual follow-up.
The recorded group labels are “Placebo/ Denosumab 60 mg Q6M” and “Denosumab/ Denosumab 60 mg Q6M.” They distinguish treatment histories in the extension record; they should not be read as denosumab versus placebo arms during the extension. The registry explicitly identifies the study as not a randomized comparison and says the arms are not a like-for-like control comparison.
Safety monitoring was the primary objective. Secondary outcomes listed percent change from baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and 1/3 radius, including outcomes using the earlier study baseline. The registry lists 48 outcome measures. It does not report the extension's detailed protocol, a sample-size justification, or further design details beyond those recorded.
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: All participants received open-label denosumab during this study. Results are reported by the Study 20030216 randomized treatment groups (placebo versus denosumab).
Overall Study
| Stage | Placebo / Denosumab | Denosumab / Denosumab |
|---|---|---|
| STARTED | 2207 | 2343 |
| Received Treatment | 2206 | 2343 |
| COMPLETED | 1283 | 1343 |
| NOT COMPLETED | 924 | 1000 |
Reasons for not completing this period:
| Reason | Placebo / Denosumab | Denosumab / Denosumab |
|---|---|---|
| Withdrawal by Subject | 399 | 427 |
| Other | 181 | 198 |
| Adverse Event | 122 | 155 |
| Death | 101 | 110 |
| Lost to Follow-up | 73 | 61 |
| Non-compliance | 20 | 13 |
| Physician Decision | 14 | 13 |
| Requirement for Alternative Therapy | 4 | 14 |
| Protocol Deviation | 6 | 5 |
| Ineligibility Determined | 3 | 4 |
| Disease Progression | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of denosumab.
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 / Denosumab | Denosumab / Denosumab | Total |
|---|---|---|---|---|
| Participants analysed | 2207 | 2343 | 4550 | |
| Age, Continuous | years | 74.8 (SD 5.1) | 74.9 (SD 5.0) | 74.8 (SD 5.0) |
| Age, Customized: 60 - 64 years | participants | 58 | 49 | 107 |
| Age, Customized: 65 - 69 years | participants | 326 | 320 | 646 |
| Age, Customized: 70 - 74 years | participants | 672 | 716 | 1388 |
| Age, Customized: ≥ 75 years | participants | 1151 | 1258 | 2409 |
| Sex: Female, Male: Female | Participants | 2207 | 2343 | 4550 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | participants | 2063 | 2169 | 4232 |
| Race/Ethnicity, Customized: Black | participants | 16 | 19 | 35 |
| Race/Ethnicity, Customized: Hispanic or Latino | participants | 121 | 145 | 266 |
| Race/Ethnicity, Customized: Asian | participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: Japanese | participants | 3 | 5 | 8 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Other | participants | 1 | 2 | 3 |
| Bone Mineral Density T-score: Lumbar spine | T-score | -2.81 (SD 0.75) | -2.14 (SD 0.80) | -2.47 (SD 0.84) |
| Bone Mineral Density T-score: Total hip | T-score | -1.93 (SD 0.80) | -1.50 (SD 0.79) | -1.71 (SD 0.83) |
| Bone Mineral Density T-score: Femoral neck | T-score | -2.17 (SD 0.72) | -1.83 (SD 0.75) | -1.99 (SD 0.75) |
| Bone Mineral Density T-score at Study 20030216 Baseline: Lumbar spine | T-score | -2.84 (SD 0.68) | -2.83 (SD 0.67) | -2.83 (SD 0.68) |
| Bone Mineral Density T-score at Study 20030216 Baseline: Total hip | T-score | -1.85 (SD 0.79) | -1.85 (SD 0.79) | -1.85 (SD 0.79) |
| Bone Mineral Density T-score at Study 20030216 Baseline: Femoral neck | T-score | -2.11 (SD 0.71) | -2.11 (SD 0.71) | -2.11 (SD 0.71) |
| Any Historical Fracture at Age ≥ 55 Years | participants | 1089 | 1133 | 2222 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs), measured over 84 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events, with a timeframe of 84 months. It is a count of participants experiencing events, rather than a measure of how severe an event was, how long it lasted, or when it first occurred. The registry describes the primary endpoint population as participants who received at least one dose of denosumab.
The endpoint is used to describe safety and tolerability during extended exposure. The registry's definition of a serious adverse event includes events that are fatal, life threatening, require inpatient hospitalization or prolong existing hospitalization, cause persistent or significant disability or incapacity, involve a congenital anomaly or birth defect, or constitute another significant medical hazard. Treatment-related events are only those for which the investigator considered there a reasonable possibility of a relationship to study drug.
The description also identifies adverse events of interest, including positively adjudicated osteonecrosis of the jaw and atypical femoral fracture, hypocalcemia, potential hypersensitivity events, serious infection, malignancy, cardiac and vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain. These categories support focused safety monitoring, but the registry description alone does not establish that any event was caused by denosumab.
As a general statistical point, counts describe how many participants were recorded with events in the defined follow-up. They do not, by themselves, account for differences in time under observation. The registry record does not report a person-time analysis for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures describe two treatment-history groups followed in an extension, not two randomized treatment arms. In “Placebo/ Denosumab 60 mg Q6M,” 945 of 2206 participants were recorded with serious adverse events, and 1809 of 2206 with other adverse events. In “Denosumab/ Denosumab 60 mg Q6M,” 1014 of 2343 participants were recorded with serious adverse events, and 1920 of 2343 with other adverse events. These are participant counts, not event totals: a participant may experience more than one event, but the registry figures do not describe the number of recurrent events.
The values should be read descriptively. The groups differ by prior treatment sequence, and the record states that the extension was not a randomized comparison and that the groups are not a like-for-like control comparison. A numerical contrast between group counts would therefore not isolate a treatment effect. The record also does not provide adjusted estimates, confidence intervals, or a statistical comparison for these safety figures; it lists zero analysis entries.
The listed serious-event terms with their percentages are osteoarthritis, 4.2%; atrial fibrillation, 2.3%; pneumonia, 2.0%; cholelithiasis, 1.3%; cerebrovascular accident, 1.2%; and radius fracture, 1.1%. These values describe the posted terms; they do not establish causation or represent a complete account of all serious events. Treatment-related events required an investigator assessment of a reasonable possibility of a relationship to study drug, according to the registry description.
Several details needed to interpret safety frequencies more fully are not reported in the registry record. These include event-specific time at risk, the handling of repeat events, detailed follow-up completeness, and results for deaths. The death counts in the adverse-event record are not reported in the registry record. Without those details, the counts cannot be converted into rates or used to make a reliable comparison of risk across treatment histories.
The registry's primary objective includes immunogenicity and safety laboratory parameters, but the posted material summarized in the record does not provide corresponding results in the primary outcome description. Nor does the record provide estimates for the listed bone mineral density outcomes. Consequently, the available registry information supports a description of reported adverse-event counts and selected serious-event terms, but not a broad conclusion about long-term benefit or harm.
9. Statistical Methods Explained
Methods should be read in light of the study's single-group extension design. The registry identifies allocation as not applicable, masking as none, and the model as single group. The treatment-history labels distinguish participants who entered after placebo or denosumab; they do not create a concurrent randomized control comparison. The registry specifically cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison.
What do participant counts represent?
The primary endpoint is the number of participants with adverse events over 84 months. A participant count records whether a participant experienced an event, not how many separate episodes occurred. The adverse-event record gives at-risk and affected participant counts for serious adverse events and other adverse events within each treatment-history group. The record does not define the exact counting rules for participants with multiple events in the same category, nor does it provide event-level timelines. Those details are not reported in the registry record.
For the “Placebo/ Denosumab 60 mg Q6M” group, the serious-event count is 945 among 2206 at risk, and the other-event count is 1809 among 2206 at risk. For the “Denosumab/ Denosumab 60 mg Q6M” group, the serious-event count is 1014 among 2343 at risk, and the other-event count is 1920 among 2343 at risk. These are the posted figures; no additional rate or contrast is calculated. A count over follow-up does not account for how long each participant was observed, so it should not be treated as a person-time rate.
Why does the design matter for inference?
Randomized allocation can make groups comparable, on average, with respect to factors affecting outcomes. Here, participants had different treatment histories before entering the extension, and the study did not allocate them to a concurrent denosumab or placebo comparison. Differences between the recorded groups could reflect prior treatment or other differences, as well as chance; the registry does not provide analyses to separate these possibilities. The posted event counts therefore describe the recorded groups rather than estimating a causal effect of one treatment history versus another.
Open-label treatment means the assigned treatment was not masked. General statistical consideration: knowledge of treatment can influence event reporting, clinical assessment, or decisions to investigate an event. This does not show that reporting was biased in this study; it identifies a possible limitation of open-label safety data. The registry record does not report procedures that would quantify or rule out such influences.
How should serious adverse events be understood?
The registry defines serious adverse events by their consequences or medical significance: fatality, life threat, inpatient hospitalization or prolonged hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or another significant medical hazard. Seriousness is not synonymous with severity on a symptom scale. The registry also distinguishes treatment-related events, which were those for which the investigator indicated a reasonable possibility of a connection to study drug. An investigator's attribution is not the same as proof of causality.
The adverse events of interest are specified as monitored risks or potential risks, with adjudication noted for osteonecrosis of the jaw and atypical femoral fracture. Their inclusion reflects the study's monitoring scope; it does not imply that each event occurred or was caused by treatment. The listed serious-event terms and percentages should be interpreted as descriptive entries, not as a complete causal assessment.
What can uncertainty estimates tell a reader?
General statistical explanation: a confidence interval describes a range of estimates compatible with the observed data under a stated statistical method and assumptions. It helps show how precisely an estimate is determined; it does not guarantee that the true value lies within the interval. The registry record does not provide confidence intervals or inferential analyses for these adverse-event counts. Without such estimates, the precision of a comparison between treatment-history groups cannot be assessed from the posted counts alone.
General statistical explanation: over-dispersion occurs when observed variability exceeds what a chosen statistical model expects. It can make standard errors too small if the model does not account for the extra variability. This concept may matter for outcomes involving repeated events, but the posted primary endpoint is a participant count, and no recurrent-event model is reported. The record does not describe an analysis of repeat events or an adjustment for over-dispersion.
What analysis details are absent?
The registry lists zero analysis entries. It does not report a statistical analysis plan, interim analyses, inferential comparisons, adjustment for baseline differences, or a sample-size justification. It also does not describe missing-data methods, censoring rules, or sensitivity analyses for the primary endpoint. Those omissions prevent readers from determining how particular analytic choices might affect the results.
The registry lists secondary bone mineral density outcomes as percent changes from specified baselines and by visit. These are different outcome types from participant counts for adverse events. The record does not provide the numerical results or analysis methods for those outcomes in the information. General statistical consideration: continuous outcomes such as percent change and binary participant outcomes answer different questions and should not be combined into one effect estimate without an explicit method. No such combined analysis is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 48 outcome measures, including safety outcomes and several bone mineral density outcomes. When many outcomes or repeated assessments are examined, the chance of observing an apparently notable result by chance can increase. General statistical approaches to this issue include prespecifying a primary outcome, adjusting for multiple comparisons, or clearly labeling secondary and exploratory analyses. The registry identifies a primary safety objective and lists secondary bone mineral density outcomes, but multiplicity procedures are not reported in the registry record.
The registry lists zero analysis entries. It does not report the analysis plan, which outcomes were included in any formal testing, whether tests were adjusted for multiple comparisons, or whether interim analyses were conducted. These details are not reported in the registry record, so statistical significance and family-wise error control cannot be evaluated from the posted information.
The record defines the primary endpoint population as participants who received at least one dose of denosumab. It does not describe how participants with incomplete follow-up, missing event information, withdrawal, or other missing data were handled. Missing-data methods, censoring rules, and the number of participants with complete endpoint information are not reported in the registry record. As a general statistical matter, missingness can affect estimates when the likelihood of missing information is related to participant characteristics or outcomes; the direction and extent of any effect cannot be determined without relevant details.
The record does not report an analysis population for the listed bone mineral density outcomes or explain how the earlier study baseline was applied. No assumptions about these procedures can be made from the outcome titles alone. The posted counts are therefore best treated as descriptive registry results, with no basis in the record for reconstructing multiplicity adjustments or missing-data analyses.
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 |
|---|---|---|---|
| Placebo/ Denosumab 60 mg Q6M | 945 | 2206 | 42.8% |
| Denosumab/ Denosumab 60 mg Q6M | 1014 | 2343 | 43.3% |
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 |
|---|---|
| Placebo/ Denosumab 60 mg Q6M | 1809 of 2206 |
| Denosumab/ Denosumab 60 mg Q6M | 1920 of 2343 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo/ Denosumab 60 mg Q6M | Denosumab/ Denosumab 60 mg Q6M |
|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 79 of 2206 | 99 of 2343 |
| Pneumonia | Infections and infestations | 44 of 2206 | 48 of 2343 |
| Atrial fibrillation | Cardiac disorders | 50 of 2206 | 40 of 2343 |
| Cholelithiasis | Hepatobiliary disorders | 22 of 2206 | 30 of 2343 |
| Cerebrovascular accident | Nervous system disorders | 22 of 2206 | 29 of 2343 |
| Radius fracture | Injury, poisoning and procedural complications | 25 of 2206 | 22 of 2343 |
| Myocardial infarction | Cardiac disorders | 21 of 2206 | 24 of 2343 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 21 of 2206 | 24 of 2343 |
| Transient ischaemic attack | Nervous system disorders | 21 of 2206 | 19 of 2343 |
| Hypertension | Vascular disorders | 18 of 2206 | 21 of 2343 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo/ Denosumab 60 mg Q6M | Denosumab/ Denosumab 60 mg Q6M |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 527 of 2206 | 541 of 2343 |
| Back pain | Musculoskeletal and connective tissue disorders | 501 of 2206 | 493 of 2343 |
| Hypertension | Vascular disorders | 460 of 2206 | 498 of 2343 |
| Nasopharyngitis | Infections and infestations | 372 of 2206 | 385 of 2343 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 332 of 2206 | 355 of 2343 |
| Cataract | Eye disorders | 319 of 2206 | 317 of 2343 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 264 of 2206 | 293 of 2343 |
| Fall | Injury, poisoning and procedural complications | 240 of 2206 | 268 of 2343 |
| Urinary tract infection | Infections and infestations | 242 of 2206 | 250 of 2343 |
| Bronchitis | Infections and infestations | 206 of 2206 | 226 of 2343 |
Serious events with the highest arm-level rate: osteoarthritis (4.2%), atrial fibrillation (2.3%), pneumonia (2.0%), cholelithiasis (1.3%), cerebrovascular accident (1.2%).
The serious adverse-event figures are participant counts. In the “Placebo/ Denosumab 60 mg Q6M” group, 945 of 2206 participants were affected; in the “Denosumab/ Denosumab 60 mg Q6M” group, 1014 of 2343 participants were affected. The other-adverse-event counts are 1809 of 2206 and 1920 of 2343, respectively. The registry lists no death counts; deaths are not reported in the registry record.
The group labels reflect prior treatment sequences, and the extension is not a randomized comparison. The counts should not be read as a direct estimate of the difference between denosumab and placebo. They also do not indicate the number of events per participant, their timing, or the time each participant was observed. The registry does not report person-time rates for these figures.
The serious-event terms listed include osteoarthritis, atrial fibrillation, pneumonia, cholelithiasis, cerebrovascular accident, and radius fracture, with the percentages shown in the registry. These are descriptive terms, not evidence that denosumab caused the events. Treatment-related classification depended on investigator judgment that a reasonable possibility of a relationship existed.
12. What the Result Does, and Does Not, Mean
The registry record describes a long-term, open-label extension in which participants received denosumab and safety was monitored. It reports participant counts for serious and other adverse events in two groups defined by treatment history. It also identifies selected serious-event terms and lists bone mineral density outcomes. These details show what the extension was designed to observe and what safety counts were posted.
The record does not establish that denosumab caused the reported events. Some events may occur during follow-up without being related to treatment, and the registry's treatment-related classification is based on investigator assessment of a reasonable possibility of connection. The event counts alone cannot distinguish background events from treatment-related events.
Nor do the group counts establish a comparative treatment effect. The extension was not randomized, had no concurrent placebo group, and is explicitly described as not a like-for-like control comparison. Prior treatment histories differ between the groups. The record does not report adjusted comparisons or confidence intervals that would help quantify uncertainty in any contrast.
The primary objective mentions safety and tolerability, immunogenicity, and safety laboratory parameters. The registry information does not provide complete results for each of those domains. It lists 48 outcome measures, including bone mineral density outcomes, but the record does not report analysis entries. The available information therefore cannot support conclusions about the size or precision of bone mineral density changes, or about the full profile of laboratory and immunogenicity findings.
General statistical interpretation: a descriptive count can be useful for understanding how many participants were recorded with an outcome, while remaining limited as evidence about causality, rates, or comparative risk. The registry record supports a description of the posted safety counts and outcome scope. It does not provide enough reported analysis detail to determine comparative effectiveness or to make a causal claim about safety.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between long-term safety description and randomized treatment comparison. An extension can continue observation after an earlier study and record events during ongoing treatment. However, group labels based on prior treatment do not automatically create a valid control group. Here, the registry explicitly identifies a single-group, open-label extension and cautions that the recorded groups are not a like-for-like comparison.
The endpoint also illustrates why the unit of analysis matters. The posted safety figures count participants affected, not the total number of events or the time to an event. Such counts answer how many participants were recorded with an event in the registry's categories, but they do not describe recurrence, timing, or person-time rates. Those distinctions are important when interpreting extended follow-up.
The registry identifies a broad monitoring scope, including serious events, treatment-related events, and specified events of interest, alongside bone mineral density outcomes. This helps readers distinguish safety surveillance from efficacy-oriented measures. Yet the record lists zero analysis entries, so the listed outcome scope is not accompanied by reported inferential estimates, uncertainty intervals, or analysis methods.
For biostatisticians and clinical researchers, the record underscores the importance of reporting analysis populations, follow-up duration, missing-data handling, event definitions, and the statistical plan. Those details are needed to assess precision and potential bias, especially in open-label extensions with prior treatment histories. The registry entries make the design and endpoint definitions visible, while also showing why descriptive long-term safety counts should not be overinterpreted as causal comparisons.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations affect interpretation. The extension was open label and had no concurrent randomized control group. The registry explicitly states that it was not a randomized comparison and that its groups are not a like-for-like control comparison. The two recorded groups differ in prior treatment sequence, so their posted counts cannot isolate the effect of denosumab from prior treatment history or other group differences.
The primary endpoint is a participant count over 84 months, but the record does not report individual follow-up time, event timing, repeat-event handling, or person-time rates. The death counts are not reported in the registry record. As a result, the posted data cannot fully characterize the time course or burden of events.
The registry lists 48 outcome measures but zero analysis entries. It does not report inferential estimates, confidence intervals, a statistical analysis plan, multiplicity procedures, interim analyses, or a sample-size justification. Missing-data methods, censoring rules, and sensitivity analyses are also not reported in the registry record. These omissions limit assessment of precision, bias, and the robustness of any analysis.
The study objective includes immunogenicity and safety laboratory parameters, but results for those domains are not reported in the registry record. Bone mineral density outcomes are listed, but corresponding numerical results and analysis details are not reported in the registry record. The limitations are therefore not only about design: the available registry information also leaves important outcome results and analytic details unspecified.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis — NCT00523341.
- Registry record last updated 2022-11-07; status last verified 2022-11.
- Results first posted 2016-07-12.
- 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
NCT00523341 is a completed phase 3, open-label, single-group extension study sponsored by Amgen. It enrolled 4550 participants and studied denosumab for postmenopausal osteoporosis. The study started on 2007-08-07 and reached primary completion on 2015-07-19. Participants received a 60 mg subcutaneous injection every 6 months for seven years.
The primary objective concerned safety and tolerability, and the primary outcome was the number of participants with adverse events over 84 months. The record reports serious and other adverse-event participant counts for two groups identified by prior treatment sequence. It lists 48 outcome measures, including bone mineral density outcomes, but zero analysis entries. The extension was not a randomized comparison, and the groups are not a like-for-like control comparison.