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 Teriparatide in Japanese Osteoporosis Patients (NCT01430104), a na phase 4 study. The primary outcome is Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01430104 |
| Phase | Phase 4 |
| Condition | Osteoporosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned osteoporosis patients in Japan. The registry lists 30 enrolled participants. For the primary analysis, the specified population was participants who received at least 1 dose of teriparatide and had a serum-calcium assessment at either 16 or 24 hours after dosing on Day 28. The record does not describe additional eligibility details in the information available for this analysis.
Intervention
Participants received teriparatide together with calcium and active vitamin D. The treatment description specifies Aspara-CA 600 mg and Alfarol 1.0 µg orally once daily throughout the study, with teriparatide 20 µg administered subcutaneously once daily during the 28-day Treatment Period. The study’s stated purpose was to assess serum calcium when teriparatide was used with active vitamin D.
Comparator
The registry describes a single treatment group, with allocation recorded as NA and masking recorded as none. It does not describe a randomized or concurrent control group. Consequently, the study does not provide a like-for-like treatment comparison that can separate changes during the study from other influences on serum calcium.
Primary question
The primary endpoint counted participants whose corrected serum calcium level was over 11.0 mg/dL at the specified Day 28 postdose assessments. This is a threshold-based safety question about observed calcium levels during the treatment regimen. The registry record does not report the primary endpoint result, so the number meeting the threshold cannot be stated from the available record.
3. Trial Design
The registry identifies NCT01430104 as a completed Phase 4 study titled A Study of Teriparatide in Japanese Osteoporosis Patients. Its official title describes assessment of serum calcium when teriparatide is used with active vitamin D in osteoporosis patients. The listed enrollment is 30. The study is recorded as a single-group design, with allocation listed as NA and masking listed as none. These features indicate that the registry does not describe a randomized comparison or blinded assessment.
The study schedule included a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Vitamin D and calcium supplementation began during the Lead-in Period and continued throughout the study. Daily teriparatide was added during the Treatment Period. The regimen description specifies Aspara-CA 600 mg and Alfarol 1.0 µg orally once daily throughout the study, and teriparatide 20 µg subcutaneously once daily for 28 days during treatment.
The primary endpoint was assessed on Day 28, at 16 and 24 hours after the teriparatide dose. The analysis population was not simply everyone enrolled: the registry specifies participants who received at least 1 dose of teriparatide and had either a 16-hour or 24-hour postdose serum-calcium assessment on Day 28. The number who met those conditions is not reported in the registry record.
Secondary outcomes concerned additional serum-calcium thresholds and measurements, urine calcium, and vitamin D concentrations. The registry lists no separate analysis records. A detailed statistical analysis plan, including the rationale for the enrollment target, is not reported in the registry record. Because there is no described control group, the design addresses outcomes observed during the treatment regimen rather than a controlled estimate of treatment differences.
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.
14-Day Lead-In Period
| Stage | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
28-Day Teriparatide Treatment Period
| Stage | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|
| STARTED | 29 |
| Received at Least 1 Dose of Teriparatide | 29 |
| COMPLETED | 28 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|
| Adverse Event | 1 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.
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 | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|---|
| Participants analysed | 29 | |
| Age Continuous | years | 70 (SD 4.4) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 29 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 29 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Japan | participants | 29 |
| Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day): Urine calcium excreted >0.3 g/day | participants | 0 |
| Number of Participants with Urine Calcium Excreted Over 0.3 Grams per Day (g/day): Urine calcium excreted ≤0.3 g/day | participants | 29 |
| Mean Urine Calcium Excreted | grams per day (g/day) | 0.12 (SD 0.05) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL), measured over Day 28 (16 and 24 hours postdose).
| 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 corrected serum calcium over 11.0 mg/dL at the Day 28 assessments 16 and 24 hours after dosing. It is a count based on whether a participant crossed a specified laboratory threshold, rather than a measure of the average calcium level or the size of a change. The registry describes corrected calcium as total serum calcium concentration adjusted by serum albumin concentration: total serum calcium in mg/dL plus 4.0 minus serum albumin in g/dL.
A threshold endpoint can make a clinically relevant laboratory boundary explicit and can describe how many participants reached it during the specified assessment period. It does not, by itself, show the distribution of values below the threshold, how far any value exceeded it, or how long an elevation lasted. Those questions require additional measurement summaries and timing information.
The endpoint is used in this study because the stated research purpose concerns serum calcium during combined use of teriparatide and active vitamin D. The registry also lists secondary outcomes for mean serum calcium, change from baseline, and the number above a higher serum-calcium threshold. However, the primary endpoint result is not reported in the registry record. Its definition is available, but the observed count and its precision cannot be assessed from the record information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the question the study was designed to address: whether participants receiving teriparatide with calcium and active vitamin D had corrected serum-calcium levels over 11.0 mg/dL at the specified Day 28 postdose assessments. It does not report the observed result for that primary endpoint. Accordingly, no event count, estimate of the frequency of threshold exceedance, or confidence interval for that outcome can be stated. The absence of a reported result is not evidence that the event did or did not occur.
The design is single-group, and no concurrent comparator is described. A result from a single treatment group would describe what was observed among participants meeting the analysis criteria. It would not establish how those observations compare with what would have happened without teriparatide or under a different regimen. General statistical interpretation: an uncontrolled before-and-after or treatment-period observation can be affected by factors other than the treatment, including natural variation in laboratory measurements and changes over time. The registry record does not provide a control group that could address those issues directly.
The primary outcome is a binary threshold count: participants either meet the defined threshold criterion or do not. Such a count can be useful for communicating whether a specified laboratory boundary was reached. It does not retain the full information in continuous measurements. For example, it does not distinguish values just over the threshold from substantially higher values, nor does it show variation among participants whose values stayed below it. The registry lists mean levels and changes from baseline as secondary outcomes, but their results are not reported in the registry record.
The analysis population also matters. The registry says the primary analysis included enrolled participants who received at least 1 dose and had either the 16-hour or 24-hour postdose assessment on Day 28. This definition makes receipt of treatment and availability of an assessment relevant to inclusion. The record does not report how many participants satisfied the criteria, whether some lacked measurements, or how missing measurements were handled. Therefore, the extent to which the analysis population represents all enrolled participants cannot be evaluated from the registry record.
The safety information lists 0 participants with a serious adverse event among 29 at risk and 5 participants with other adverse events among 29 at risk. These are descriptive counts, not a comparison between treatment strategies. The registry does not list serious adverse-event terms, and the death count is not reported in the registry record. Neither the safety counts nor the missing primary result support a conclusion about comparative safety or treatment effect. The most defensible interpretation is limited to the design, endpoint definition, analysis criteria, and safety counts that the registry records, while recognizing that outcome results and their precision are unavailable.
9. Statistical Methods Explained
The registry identifies a single-group study and a binary primary outcome. The endpoint counts participants whose corrected serum calcium was over 11.0 mg/dL at the specified Day 28 postdose assessments. The primary analysis population includes participants who received at least 1 dose of teriparatide and had either a 16-hour or 24-hour assessment on Day 28. The registry record does not report the count meeting the endpoint, a confidence interval, a test statistic, or an analysis model.
What does a threshold count show?
A binary endpoint classifies each participant according to whether the defined event occurred. The result is usually interpreted alongside the number of participants evaluated, because the count alone does not convey how much information supports the estimate. A confidence interval, when reported, expresses statistical uncertainty around an estimate under the assumptions of the analysis. It does not guarantee that the true value lies within the interval, and it does not correct for design limitations such as the absence of a comparator. No confidence interval for this endpoint is reported in the registry record.
Thresholding a continuous laboratory measure is straightforward to communicate, but it discards detail. Participants just above and far above the boundary are counted in the same event category. Participants below the boundary are also grouped together, even if their measurements differ. Mean serum calcium and change from baseline can describe different aspects of the measurements, but the registry record does not report their results. Corrected calcium is specified as total serum calcium in mg/dL plus 4.0 minus serum albumin in g/dL, so the endpoint uses an albumin-adjusted rather than unadjusted total calcium value.
What does a single-group design permit?
In a single-group study, observed outcome counts describe the participants who received the regimen and met the analysis criteria. General statistical explanation: a comparison group helps distinguish a treatment-associated difference from changes that might also occur over time or under other conditions. Without such a group, a study cannot estimate a between-group treatment contrast. The registry lists allocation as NA and masking as none, and its design is explicitly single-group. Thus, an inferential comparison with another treatment is not available from this record.
Even when a single-group study reports a baseline measurement and a later measurement, a change from baseline is not automatically a causal treatment effect. Such a change can reflect measurement variation, time effects, or other influences. The registry lists change from baseline in serum calcium among the secondary outcomes, but does not report that result or describe an adjustment strategy. The registry record also does not report a detailed statistical analysis plan, interim analyses, or a sample-size justification.
How should the planning illustrations be read?
Any sample-size calculations associated with the posted results are planning illustrations, not observed power. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Those assumptions describe hypothetical planning comparisons. They do not match the registered single-group design, which has no equal allocation between treatment arms. Such calculations should not be interpreted as the study’s original sample-size rationale, evidence that the study had adequate power, or a retrospective measure of the chance of detecting an effect.
In general, sample-size planning depends on an effect size, variability or event rate, statistical error targets, and design choices. A planning estimate is conditional on those assumptions. If the assumed effect differs from the effect that would be relevant in a future study, the resulting sample size may not suit that study. The registry record does not report the original design justification, so the planning assumptions should be kept distinct from the trial’s actual design and from its observed outcomes.
Why can over-dispersion matter?
General explanation: for count outcomes, an analysis may assume a particular relationship between the average count and its variability. Over-dispersion means that the observed variation is greater than that assumption allows. If it is ignored, uncertainty can be understated and statistical conclusions may appear more precise than warranted. This study’s primary outcome is a participant count for a binary event, and the registry does not report a count-regression model or an over-dispersion assessment. Therefore, over-dispersion should be understood as a general modelling issue, not as a feature established for this trial.
The available information supports a description of the endpoint and its intended population, but not a reconstruction of the analysis. Details such as confidence-interval methods, covariate adjustment, rules for combining the 16-hour and 24-hour assessments, and handling of missing data are not reported in the registry record. Without those details and the primary result, the statistical precision and robustness of the endpoint estimate cannot be judged.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes spanning serum calcium, urine calcium, and vitamin D concentrations. When a study evaluates multiple outcomes, the chance of at least one apparently unusual result can increase if each is assessed without accounting for multiplicity. General statistical explanation: multiplicity procedures can control a chosen error rate across a family of tests, or investigators can identify a primary outcome and treat other findings as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or an analysis plan describing how secondary results were to be interpreted.
The primary analysis population is defined as enrolled participants who received at least 1 dose of teriparatide and had either a 16-hour or 24-hour postdose serum-calcium assessment on Day 28. This is useful information about eligibility for the primary analysis, but the record does not report how many participants met the criteria. It also does not state whether every participant had both assessments, how an assessment at one time point was used when the other was unavailable, or how missing outcome values were handled. Those details are not reported in the registry record.
The registry lists 30 enrolled participants, while the safety group lists 29 at risk. These figures describe different reported quantities; the record does not explain the difference. It would be inappropriate to assume a reason for it or to treat the enrollment count as the primary analysis denominator. No separate analysis records are listed in the registry. Interim analyses and the statistical plan are not reported in the registry record, so their presence or absence cannot be inferred from the outcome definitions alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 0 | 29 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide | 5 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide |
|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | 1 of 29 |
| Diarrhoea | Gastrointestinal disorders | 1 of 29 |
| Cystitis | Infections and infestations | 1 of 29 |
| Nasopharyngitis | Infections and infestations | 1 of 29 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 29 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 1 of 29 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 29 |
The registry lists 29 participants at risk for serious adverse events and reports 0 participants affected. It also lists 29 at risk for other adverse events and reports 5 participants affected. These are descriptive counts for the listed treatment group: 600 mg Aspara-CA, 1 µg Alfarol, and 20 µg teriparatide. They are not comparative estimates because the record describes a single treatment group without a control group.
A count of 0 serious adverse events in the listed group should be read as the registry’s reported observation for that group, not as proof that serious events are impossible or that risk is absent. With no comparator, the figures cannot show whether the observed event burden differs from another regimen or from an untreated condition. The registry’s list of serious adverse-event terms is empty, so specific serious event types are not reported in the registry record.
The deaths field is null. A null field does not provide a numeric death count; the death count is not reported in the registry record. The listed safety counts also do not give details about severity, timing, duration, or attribution beyond the categories recorded. They should therefore be interpreted narrowly as registry-reported counts, rather than as a complete account of comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed Phase 4, single-group study of teriparatide used with active vitamin D and calcium supplementation in osteoporosis patients. It specifies a primary endpoint based on the number of participants with corrected serum calcium over 11.0 mg/dL at Day 28 assessments 16 and 24 hours after dosing. It also defines the population intended for the primary analysis and lists additional serum-calcium, urine-calcium, and vitamin D outcomes.
Those details clarify what the study set out to observe, but the primary outcome result is not reported in the registry record. The record therefore does not establish how many participants crossed the primary threshold, how precise an estimate would be, or how the observed calcium measurements varied. The listed secondary outcome definitions do not substitute for their results. A missing result should not be interpreted as a result of zero events or as evidence of no change.
The study’s single-group design also limits what a reported outcome could mean. A count during treatment could describe events in the treatment group, but it would not by itself estimate a difference relative to another treatment or establish that teriparatide caused any observed change. The record does not identify a control group or a randomized comparison. Similarly, the safety counts describe events reported for the listed group; they do not measure comparative risk.
General statistical explanation: statistical precision depends on both the observed data and the analysis used. A point estimate without its uncertainty can give an incomplete impression, while uncertainty intervals cannot remove bias caused by study design or incomplete data. Here, the outcome estimate and its precision are not reported. The registry record also does not report missing-data handling, a detailed statistical plan, or the rationale for enrollment.
The available information supports a careful account of the regimen, schedule, endpoint definition, analysis-population criteria, and recorded safety counts. It does not support a claim that the treatment did or did not change serum calcium, nor a conclusion about efficacy or comparative safety. Those questions would require outcome results and, for comparative conclusions, an appropriate comparison design.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a clearly defined laboratory threshold and a single-group design answer different kinds of questions. The primary endpoint identifies a specific corrected serum-calcium boundary and a specified assessment period. That definition allows readers to understand the event being counted. At the same time, a threshold count cannot convey the full pattern of laboratory measurements, and the registry record does not report the primary result or the related continuous-outcome results.
The single-group structure is central to interpretation. The record describes observation during a regimen of teriparatide with active vitamin D and calcium, rather than a randomized contrast against another regimen. This makes descriptive reporting possible, but it limits causal interpretation. A treatment-period observation cannot, on its own, separate treatment-associated changes from other influences over time. The absence of masking is also part of the design information, although the registry does not describe its consequences for measurement or reporting.
The endpoint definition also makes analysis-population details important. The primary analysis required receipt of at least 1 dose and an available Day 28 postdose assessment at either specified time. The registry record does not report how many participants met these conditions or how missing assessments were handled. Without the denominator and missing-data methods, the completeness and precision of the primary outcome cannot be judged.
Finally, this record illustrates why safety counts, endpoint definitions, and planning calculations must not be conflated. The safety figures are descriptive, the primary outcome result is unavailable, and any sample-size calculations are planning illustrations based on stated assumptions rather than observed power or the study’s original design rationale. Keeping those distinctions clear prevents a study description from being mistaken for evidence of a comparative treatment effect.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint result is not reported in the registry record. This prevents assessment of the observed event count, the size of any estimate, and its statistical precision. The registry defines a primary analysis population based on treatment receipt and availability of a Day 28 postdose measurement, but does not report how many participants met those criteria. The relationship between the enrollment figure and the analysis population therefore cannot be assessed from the record.
The design is single-group, with allocation listed as NA and masking listed as none. No concurrent control group is described, so the study cannot provide a controlled estimate of the difference between treatment strategies. The absence of a comparator is a design limitation for causal and comparative interpretation, regardless of whether a descriptive result is reported.
Details that would help evaluate the analysis are not reported in the registry record. These include the statistical analysis plan, the handling of missing measurements, the treatment of results when only one of the specified postdose assessments was available, any multiplicity procedure, and the rationale for the enrollment target. Interim analyses are not reported in the registry record. No separate analysis records are listed.
The safety information is also limited to the listed counts. Specific serious adverse-event terms are not reported in the registry record, and the death count is not reported. The record does not describe event timing, severity, or attribution beyond the reported categories. The listed counts should not be taken as comparative risk estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Teriparatide in Japanese Osteoporosis Patients — NCT01430104.
- Registry record last updated 2013-01-14; status last verified 2012-11.
- Results first posted 2012-12-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01430104 is recorded as a completed Phase 4, single-group study of teriparatide with active vitamin D and calcium supplementation in osteoporosis patients. The registry lists 30 enrolled participants and describes a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period, in addition to screening. The primary endpoint was the number of participants with corrected serum calcium over 11.0 mg/dL at the Day 28 assessments 16 and 24 hours after dosing.
The primary analysis population required at least 1 teriparatide dose and either specified postdose assessment. The primary result, its precision, missing-data handling, and detailed statistical plan are not reported in the registry record. Safety counts list 0 serious adverse events and 5 other adverse events among 29 at risk; the death count is not reported. The single-group design does not support a controlled treatment comparison.