Comparison · NCT03324880-383bb244
rhPTH (1-84) vs Placebo: Number of Participants With Response at Week 26 [Early Termination (ET)]
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. rhPTH (1-84) vs Placebo: Number of Participants With Response at Week 26 [Early Termination (ET)]. Trial comparisons, record NCT03324880-383bb244. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03324880-383bb244
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.781 | 0.612 | 0.89 | wilson | |
| Risk in group 2 | 0.632 | 0.473 | 0.766 | wilson | |
| Risk difference, group 1 minus group 2 | 0.15 | -0.0662 | 0.342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.912 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 2.08 | 0.717 | 6.05 | log | |
| Number needed to treat, for one more participant with the outcome on rhPTH (1-84) than on Placebo | 6.68 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | rhPTH (1-84) | Participants received rhPTH (1-84) 50 mcg SC injection QD, titrated within the dose range of 25-100 mcg QD as an adjunctive treatment with active vitamin D and calcium supplements based on metabolic response up to 32 weeks. | 25 | 32 | OG001 |
| Group 2 | Placebo | Participants received placebo matched to rhPTH (1-84) as SC injection QD with active vitamin D and calcium supplements up to 31.3 weeks. | 24 | 38 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Response at Week 26 [Early Termination (ET)]
- Description
Response was defined as a 30% reduction in HypoPT-SD symptom subscale score from baseline. The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Data reported also includes results for early terminated participants.
- Time frame
- Baseline up to Week 26
- Population
- ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
- NCT number
- NCT03324880
- Phases
- PHASE4
- Conditions
- Hypoparathyroidism
- Interventions
- rhPTH (1-84), Placebo
- Lead sponsor
- Shire
- Results first posted
- 2023-06-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03324880?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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