Comparison · NCT03324880-8ea94812
rhPTH (1-84) vs Placebo: Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. rhPTH (1-84) vs Placebo: Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26. Trial comparisons, record NCT03324880-8ea94812. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03324880-8ea94812
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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 | 0.525 | 0.375 | 0.671 | wilson | |
| Risk in group 2 | 0.128 | 0.0598 | 0.252 | wilson | |
| Risk difference, group 1 minus group 2 | 0.397 | 0.203 | 0.558 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.11 | 1.84 | 9.18 | log | |
| Odds ratio, group 1 over group 2 | 7.55 | 2.62 | 21.8 | log | |
| Number needed to treat, for one more participant with the outcome on rhPTH (1-84) than on Placebo | 2.52 | 1.79 | 4.93 | from the risk difference interval |
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. | 21 | 40 | 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. | 6 | 47 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26
- Description
Number of participants achieving composite criteria of the following: albumin-corrected serum calcium between 1.875 mmol/L (7.5 mg/dL) and the ULN for the central laboratory normal range, dose of active vitamin D decreased by 50% and at least a 50% reduction from the baseline oral elemental calcium supplement dose at Week 26 was reported.
- Time frame
- 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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