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 Effects of Anorexia Nervosa on Peak Bone Mass (NCT01301183), a randomized phase 3 study. The primary outcome is Change in Bone Density Over a 12-month Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01301183 |
| Phase | Phase 3 |
| Condition | Anorexia Nervosa |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 75 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Adolescent girls with anorexia nervosa. The registry describes concern about low bone density and low rates of bone accrual in this population. It also explains that the study focused on whether bone density might increase and whether bone mass might approach that seen in healthy adolescent girls.
Intervention
Recombinant human IGF-1, also called rhIGF-1, given with transdermal 17-beta estradiol. The registry describes the estradiol as physiologic replacement intended to mimic pubertal hormone levels.
Comparator
Placebo with transdermal 17-beta estradiol. Estradiol was therefore part of both arms; the comparison was the addition of rhIGF-1 versus placebo alongside estradiol.
Primary question
Whether adding rhIGF-1 to estradiol changes lumbar spine bone mineral density z-score over a 12-month period, compared with estradiol alone. The registry identifies change in bone density over a 12-month period as the primary outcome and describes positive change in z-score as favorable.
The biological rationale in the registry distinguishes estrogen's role in preventing bone loss from IGF-1's role in optimizing bone formation. It also notes that estrogen replacement had previously been associated with increased bone density in teenage girls with anorexia nervosa, while residual deficits remained. The stated question is therefore about the added contribution of rhIGF-1 in the context of estradiol replacement, not about rhIGF-1 alone or estradiol versus no estradiol.
The primary outcome is a change score rather than a follow-up value alone. A between-arm analysis of change asks whether the recorded movement in lumbar spine BMD z-score differs between the two assigned groups. The posted group summaries describe medians, while the registry's reported comparative analysis is ANCOVA. The numerical result does not by itself establish why the groups may differ, and the registry does not report enough detail to reconstruct an adjusted effect estimate.
3. Trial Design
The registry classifies this as a Phase 3, randomized, double-masked, parallel-group trial. The parallel design assigns participants to one of two groups followed over the same study period: rhIGF-1 with transdermal estradiol, or placebo with transdermal estradiol. Randomization is intended, in general, to support a fair comparison by distributing participant characteristics across groups, while masking is intended to limit influences of treatment knowledge on study conduct or assessment. The registry does not report the randomization procedure or details of who was masked.
The recorded enrollment is 75. The primary outcome is change in lumbar spine BMD z-score over 12 months. The outcome summaries list 12 participants in the rhIGF-1 group and 21 in the placebo group. Those outcome counts are not the same as the overall enrollment figure, and the registry record does not explain the flow from enrollment to the reported primary outcome groups. Safety summaries use at-risk counts of 38 and 37 for the two groups, respectively; those counts differ from the primary outcome counts. Reasons for these differences are not reported in the registry record.
The registry records a start date of 2011-02, primary completion in 2019-03, and status as completed. Massachusetts General Hospital is listed as the sponsor. The intervention names identify rhIGF-1 with transdermal 17-beta estradiol and placebo with transdermal 17-beta estradiol. The record identifies anorexia nervosa as the condition.
The posted results include two outcome measures and two analyses. One secondary outcome is change in trabecular number at the ultradistal radius over a 12-month period. A numerical result for that secondary outcome is not reported in the registry record. Details such as the recruitment pathway, eligibility criteria, treatment duration beyond the outcome timeframe, dose schedule, adherence, randomization method, and masking procedures are not reported in the registry record. The registry also does not report the protocol's sample-size justification or a detailed statistical analysis plan.
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.
Overall Study
| Stage | Rh IGF-1 + Transdermal Estradiol | Placebo + Transdermal Estradiol |
|---|---|---|
| STARTED | 38 | 37 |
| COMPLETED | 12 | 21 |
| NOT COMPLETED | 26 | 16 |
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 | Rh IGF-1 + Transdermal Estradiol | Placebo + Transdermal Estradiol | Total |
|---|---|---|---|---|
| Participants analysed | 38 | 37 | 75 | |
| Age, Categorical: <=18 years | Participants | 7 | 9 | 16 |
| Age, Categorical: Between 18 and 65 years | Participants | 31 | 28 | 59 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 19.4 (SD 2.0) | 19.3 (SD 2.3) | 19.3 (SD 2.0) |
| Sex: Female, Male: Female | Participants | 38 | 37 | 75 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 4 | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 37 | 33 | 70 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 34 | 33 | 67 |
| Race (NIH/OMB): More than one race | Participants | 3 | 4 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 38 | 37 | 75 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Bone Density Over a 12-month Period, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in lumbar spine bone mineral density z-score over 12 months, assessed by dual energy x-ray absorptiometry. A z-score expresses how far a person's BMD is from the mean for age, sex, and race. The registry describes a score of 0 as equal to that reference mean; negative values are below the mean and positive values are above it. For the change score, positive movement is described as favorable and negative movement as unfavorable.
A standardized score offers context for interpreting BMD in relation to the stated reference characteristics. It is distinct from an absolute BMD measurement: the endpoint records change in the z-score, so it reflects movement relative to the reference mean rather than only a raw measurement. Such a change measure can be useful when the research question concerns whether groups differ in bone-density trajectory over a defined period.
The registry reports the primary outcome as a median for each group. It does not report the interquartile ranges, despite identifying the interquartile range as the dispersion measure, and it does not state the confidence level for the listed interval bounds. Those omissions limit assessment of the distribution and precision of each group's summary. The comparative ANCOVA result is reported as a p-value, but the adjusted contrast and its uncertainty are not reported in the registry record. The endpoint speaks to lumbar spine BMD z-score change; it does not, by itself, establish changes in fracture risk or other clinical outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary outcome, the median change in lumbar spine BMD z-score was 0.045 in the rhIGF-1 plus transdermal estradiol group, with reported lower and upper bounds of -0.083 and 0.174. In the placebo plus transdermal estradiol group, the median change was 0.28, with reported bounds of 0.085 and 0.475. The outcome summaries list 12 participants and 21 participants, respectively. These are descriptive group summaries; they are not an adjusted estimate of the difference between groups.
The registry reports an ANCOVA comparison with p = .109. This p-value is not an estimate of the size of the between-group effect. It describes how compatible the observed data are with a specified null model under the analysis assumptions; it does not give the probability that the null hypothesis is true or establish that there is no difference. The registry does not report the adjusted contrast, its confidence interval, covariates included in the model, or the exact analysis population. These omissions prevent a full assessment of the size and precision of the adjusted comparison.
The arm-level interval bounds overlap, but that observation is not a substitute for the comparative ANCOVA result. The reported intervals are attached to separate group summaries, and the registry does not identify their confidence level. The group medians also cannot be subtracted to reproduce an adjusted ANCOVA estimate. No new numerical contrast should be inferred from those summaries.
The primary outcome record identifies median and interquartile range as the summary approach, but no interquartile-range values are posted. Without those values or the underlying participant data, the spread and shape of the outcome distributions cannot be assessed from the registry record. The outcome counts also differ from the recorded enrollment, and no explanation for that difference is reported. Thus, the posted result should be read as an incomplete account of the primary analysis rather than a full statistical report.
The result concerns change in lumbar spine BMD z-score over the specified period in the two trial groups. It does not establish a treatment effect on bone strength, fracture risk, later bone health, or outcomes beyond those measured. The registry describes a secondary trabecular-number outcome, but its numerical result is not reported in the registry record. Safety summaries are separate from the primary efficacy outcome and should be interpreted on their own terms.
9. Statistical Methods Explained
The registry reports an ANCOVA for the primary comparison and medians for the group summaries. These are different statistical descriptions. The medians describe the central observed outcome within each group. ANCOVA is a model-based method that compares groups while accounting for specified covariates. The registry does not identify the covariates, model specification, or adjusted group contrast, so the ANCOVA result cannot be reconstructed from the posted medians alone.
What does a median describe?
General statistical explanation: The median is the central value after observations are ordered. It is less influenced by extreme observations than the mean, which can make it useful when a distribution is skewed. A median alone does not describe the full distribution. The interquartile range is commonly used alongside a median to show the span of the middle portion of observations. Although the registry identifies the interquartile range as the dispersion measure, those values are not reported in the registry record.
The reported median changes are 0.045 for rhIGF-1 plus estradiol and 0.28 for placebo plus estradiol. The associated reported lower and upper bounds are -0.083 and 0.174 for the former group, and 0.085 and 0.475 for the latter. The record does not specify the confidence level or method for these bounds. They should therefore be described as reported interval bounds, not assigned a particular confidence interpretation without further documentation.
What does ANCOVA contribute?
General statistical explanation: Analysis of covariance models an outcome in relation to group assignment and one or more covariates. If baseline outcome values or other prespecified variables are included, the model can estimate a group comparison adjusted for those variables. The choice and handling of covariates matter: they determine the adjusted comparison and can affect its precision. In this trial, the registry identifies ANCOVA but does not report which covariates were used, how baseline BMD was handled, or whether model assumptions were checked.
The registry's ANCOVA p-value is .109. A p-value measures compatibility between the data and a null model under the assumptions of the specified analysis. It is not an effect size and does not reveal the direction or magnitude of an adjusted difference. Without the adjusted estimate and its uncertainty interval, the precision and clinical scale of that comparison cannot be assessed from the p-value alone.
Why does dispersion matter?
General statistical explanation: Dispersion describes how much participants' outcomes vary within a group. Greater variability can make a group comparison less precise, even when the central summaries are similar. Skewness or outliers may also affect which summary is most informative and whether model assumptions are plausible. Since the interquartile ranges and individual observations are not reported, the distribution of change scores cannot be evaluated directly from the registry result.
General statistical explanation: Over-dispersion refers to variability greater than a model's assumptions anticipate. When present, standard errors can be too small if the model does not account for it, which can make uncertainty appear narrower than it is. The registry does not report a dispersion assessment, and there is no basis in the posted results for concluding that over-dispersion occurred in this analysis.
How should interval estimates be read?
General statistical explanation: A confidence interval communicates uncertainty about an estimated quantity under a statistical procedure. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. Interpretation depends on the interval's stated confidence level and the quantity being estimated. In this record, the arm-specific bounds do not have a confidence level identified, and an interval for the adjusted ANCOVA contrast is not reported. Consequently, those bounds cannot replace an uncertainty interval for the primary between-group comparison.
The posted planning description characterizes sample-size calculations as illustrations based on the observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the original trial was designed with those assumptions. Numerical planning results and the trial's own sample-size justification are not reported in the registry record.
The record also does not report the analysis population, the approach to missing outcomes, or any sensitivity analyses. Those choices can affect a model-based comparison. Without these details, the posted ANCOVA result can be stated as reported, but its robustness to analysis decisions cannot be assessed.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | not reported | 0.109 |
The registry reports the sponsor's primary comparison as ANCOVA, with p = .109. It also reports the two group medians and their interval bounds, but does not provide the adjusted ANCOVA estimate, its interval, or the model covariates. Those summaries cannot be used to recreate an adjusted result because they do not contain the participant-level information or adjustment details needed for that calculation.
The registry record does not flag a discrepancy between the sponsor analysis and a recalculated result. However, it does not report a recalculated adjusted contrast or provide enough information to reproduce one. The sponsor's ANCOVA p-value should therefore be understood as the posted comparative analysis, while the arm summaries remain descriptive. Neither the p-value nor the group medians alone communicate the adjusted effect's magnitude and precision.
The registry does not report whether the ANCOVA was prespecified in the protocol, which covariates were included, or how missing outcomes were handled. That information would help readers judge how the sponsor's analysis was constructed and whether it followed the planned approach. In its absence, interpretation should stay close to the reported outcome summaries and p-value, without treating an unreported recalculation as an alternative trial result.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome of change in bone density over a 12-month period and a secondary outcome of change in trabecular number at the ultradistal radius over a 12-month period. It reports two outcome measures and two analyses. A numerical result for the secondary outcome is not reported in the registry record. No further outcome hierarchy or multiplicity procedure is reported in the registry record.
General statistical explanation: When a trial evaluates multiple outcomes or performs multiple comparisons, the chance of obtaining at least one apparently notable result can rise if each is assessed without accounting for the others. A prespecified primary outcome and a stated multiplicity approach help clarify which findings are confirmatory and how uncertainty should be interpreted. The registry does not report whether any adjustment for multiple testing was used, or how the secondary outcome was intended to relate to the primary question. No claim about adjustment or prioritization can therefore be made.
The primary outcome summaries include 12 participants in the rhIGF-1 group and 21 in the placebo group, whereas safety summaries list 38 and 37 participants at risk. The overall enrollment is 75. The registry does not explain the differences among these counts, report participant flow by analysis, or identify an analysis population such as all randomized participants or those with observed outcomes. Reasons for missing primary outcome data are not reported in the registry record.
General statistical explanation: Missing outcome data can affect a treatment comparison when the likelihood of having an observed measurement is related to participants' outcomes or characteristics. Different analysis methods make different assumptions about missingness. Reporting the amount and reasons for missing data, the analysis population, and sensitivity analyses helps readers judge how much those assumptions matter. None of these details is reported in the registry record for the primary outcome. The record also does not report interim analyses or a detailed statistical analysis plan.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Rh IGF-1 + Transdermal Estradiol | 7 | 38 | 18.4% |
| Placebo + Transdermal Estradiol | 12 | 37 | 32.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rh IGF-1 + Transdermal Estradiol | 0 of 38 |
| Placebo + Transdermal Estradiol | 0 of 37 |
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 |
|---|---|
| Rh IGF-1 + Transdermal Estradiol | 8 of 38 |
| Placebo + Transdermal Estradiol | 19 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | Rh IGF-1 + Transdermal Estradiol | Placebo + Transdermal Estradiol |
|---|---|---|---|
| Hospitalization related to eating disorder | Psychiatric disorders | 4 of 38 | 7 of 37 |
| Suicide attempt | Psychiatric disorders | 2 of 38 | 3 of 37 |
| Suicidal ideation | Psychiatric disorders | 1 of 38 | 2 of 37 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rh IGF-1 + Transdermal Estradiol | Placebo + Transdermal Estradiol |
|---|---|---|---|
| Headache | Nervous system disorders | 2 of 38 | 3 of 37 |
| Vasovagal with venipuncture | Vascular disorders | 1 of 38 | 3 of 37 |
| Constipation | Gastrointestinal disorders | 2 of 38 | 2 of 37 |
| Irritation at patch site | Skin and subcutaneous tissue disorders | 1 of 38 | 2 of 37 |
| Irregular menses | Reproductive system and breast disorders | 0 of 38 | 3 of 37 |
| Rash at injection site | Skin and subcutaneous tissue disorders | 2 of 38 | 0 of 37 |
| Breast tenderness | Reproductive system and breast disorders | 0 of 38 | 2 of 37 |
| Dizziness with jitteriness | Vascular disorders | 0 of 38 | 2 of 37 |
| Palpitations | Cardiac disorders | 0 of 38 | 2 of 37 |
Serious events with the highest arm-level rate: hospitalization related to eating disorder (18.9%), suicide attempt (8.1%), suicidal ideation (5.4%).
The safety record lists 38 participants at risk in the rhIGF-1 plus transdermal estradiol group and 37 in the placebo plus transdermal estradiol group. Serious adverse events affected 7 and 12 participants, respectively. Other adverse events affected 8 and 19 participants, respectively. No deaths are listed in either group. These are the counts recorded for the safety categories and should not be confused with the primary outcome analysis counts.
The registry lists hospitalization related to eating disorder at 18.9%, suicide attempt at 8.1%, and suicidal ideation at 5.4% among the top serious adverse event terms. It does not identify the denominator or arm-specific distribution for each listed term in the information available for this result. These percentages should not be assigned to a particular treatment group or interpreted as a comparison between groups.
Safety counts describe events recorded during the trial, but the registry does not report event timing, severity grading beyond the serious-event classification, relatedness assessments, or the method used to summarize recurrent events. Counts of participants affected are not counts of all event episodes. The figures therefore provide a limited descriptive account and do not, by themselves, establish a causal relationship between an intervention and an event. The record reports no deaths, but the safety summaries should be interpreted with the available denominators and reporting details in mind.
13. What the Result Does, and Does Not, Mean
The posted primary outcome summaries describe change in lumbar spine BMD z-score over 12 months in two randomized groups that both received transdermal estradiol, with rhIGF-1 or placebo added. The median was 0.045 in the rhIGF-1 group and 0.28 in the placebo group. The reported ANCOVA p-value is .109. These are the observed summaries and comparison recorded for the endpoint; they do not establish a causal explanation for the pattern or provide a complete estimate of the adjusted difference.
The result is not evidence that the interventions are equivalent. A p-value of .109 does not demonstrate that a meaningful difference is absent. To judge the size and precision of the adjusted comparison, readers would need the adjusted estimate and its confidence interval, which are not reported in the registry record. The arm-specific interval bounds also do not provide that adjusted comparison, and their confidence level is not specified.
The result should be limited to the measured outcome, population, and period. It concerns lumbar spine BMD z-score change in adolescent girls with anorexia nervosa over 12 months. It does not establish what happened to fracture risk, overall bone health, other bone sites, or later outcomes. Although a trabecular-number outcome is listed, its numerical result is not reported in the registry record.
The posted primary outcome counts are 12 and 21, while the overall enrollment is 75 and the safety at-risk counts are 38 and 37. Since participant flow and missing-data handling are not reported, the relationship among those counts cannot be resolved. This limits assessment of how representative the analyzed outcome groups were of the randomized participants.
Safety results are descriptive and distinct from the primary endpoint. They include serious and other adverse-event counts, top serious event terms, and no recorded deaths. The registry does not provide enough detail to draw a treatment-causality conclusion from those summaries. Overall, the record supports a careful description of the posted outcomes, but not a broad claim about treatment benefit, absence of effect, or clinical consequences beyond what was measured.
14. Why This Trial Matters Statistically
This trial raises a statistically useful question about adding rhIGF-1 to estradiol rather than comparing either hormone with no treatment. Because both groups received transdermal estradiol, the randomized contrast is specifically the added rhIGF-1 versus placebo in that shared treatment context. Keeping the contrast clear is essential when interpreting the reported group summaries.
The record also illustrates why an effect estimate matters alongside a p-value. The ANCOVA p-value is reported, but the adjusted contrast and its uncertainty are not. A p-value alone cannot show the size of a possible group difference or how precisely it was estimated. Descriptive medians provide information about the observed centers of the groups, but they do not replace the adjusted comparison.
Reporting is consequential for interpreting a randomized study. The primary outcome counts differ from the safety at-risk counts and the enrollment total, while participant flow and missing-data handling are not described. The interquartile ranges are also absent despite being identified as the dispersion measure. These gaps make it harder to evaluate the outcome distributions, analysis population, and robustness of the primary result.
The trial's question concerns bone-density change, while broader claims about bone health involve outcomes not established by the reported endpoint. Separating the measured z-score change from unreported clinical outcomes keeps statistical interpretation within the evidence recorded. The distinction between a result that is statistically uncertain and a result that proves no difference is particularly important when the adjusted estimate and interval are unavailable.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific reporting gaps constrain interpretation. The registry reports median outcome changes and interval bounds but does not provide the interquartile ranges or state the confidence level for the bounds. The primary ANCOVA result includes a p-value but no adjusted effect estimate or uncertainty interval. Model covariates, baseline adjustment details, and model diagnostics are not reported in the registry record.
There is also a discrepancy among the reported participant counts: enrollment is 75, the primary outcome groups include 12 and 21 participants, and safety summaries list 38 and 37 at risk. These counts relate to different reported parts of the record, but no participant-flow account explains the differences. The analysis population, reasons for missing primary outcomes, and missing-data methods are not reported. As a result, the extent to which the primary summaries represent the randomized groups cannot be assessed.
The registry does not report the randomization procedure, masking details, eligibility criteria, dose schedule, adherence, or treatment discontinuation information. It also does not report the protocol's sample-size justification, interim analyses, or a detailed statistical analysis plan. The posted sample-size description characterizes calculations as planning illustrations rather than the trial's original design justification, and numerical planning results are not included in the registry record.
The secondary trabecular-number outcome is identified but has no numerical result reported in the registry record. Multiplicity handling is not reported. For safety, arm-level counts and selected serious-event terms are listed, but event-level timing, attribution, and denominator details for the terms are not reported. These limitations do not change the posted results, but they restrict how fully the estimates, uncertainty, and safety patterns can be evaluated.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Effects of Anorexia Nervosa on Peak Bone Mass — NCT01301183.
- Registry record last updated 2021-07-13; status last verified 2021-06.
- Results first posted 2021-07-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
This completed Phase 3 trial was randomized, double-masked, and parallel-group, with Massachusetts General Hospital listed as sponsor. The registry records a start date of 2011-02, primary completion in 2019-03, and enrollment of 75. The two groups received rhIGF-1 plus transdermal estradiol or placebo plus transdermal estradiol.
The primary outcome was change in lumbar spine BMD z-score over 12 months. Reported medians were 0.045 and 0.28, with arm-level outcome counts of 12 and 21. The registry reports an ANCOVA p-value of .109 but no adjusted contrast or confidence interval. The interquartile ranges are not reported in the registry record.
A secondary trabecular-number outcome is listed without a numerical result. Safety summaries report serious and other adverse-event counts and no deaths. Participant flow, missing-data methods, multiplicity handling, and key statistical-plan details are not reported in the registry record.