The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 2.5 |
| NPSP558 | 54.8 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name REPLACE
United States, Belgium, Canada, Denmark, France, Hungary, Italy, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
Placebo comparator
Placebo
Sterile water for injection
Experimental
50, 75, 100 mcg NPSP558
Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
Outcomes the sponsor listed as primary.
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.
Time frame · Week 24 of dosing
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.
Percentage Changes From Baseline in Daily Calcium Dose at Week 24.
Time frame · 24 Weeks
The analysis of this endpoint was based on investigator prescribed data.
Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.
Time frame · 24 Weeks
Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.
Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.
Time frame · 8 Weeks
Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 2.5 |
| NPSP558 | 54.8 |
| Group | Value (percentage change from baseline) | Spread |
|---|---|---|
| Placebo | 2.4 | 38.37 |
| NPSP558 | -51.8 | 45.71 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 6.1 |
| NPSP558 | 43.0 |
| Group | Value (percentage of participants) |
|---|---|
| Placebo | 37.5 |
| NPSP558 | 34.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboMatching Placebo: Placebo for subcutaneous injection | – | 4 / 40 | 38 / 40 |
| NPSP558NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily | – | 9 / 84 | 69 / 84 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2018
Vokes et al. 2018The Journal of clinical endocrinology and metabolismcited by 54
PMID 29099947PMC6458961DOI 10.1210/jc.2017-01471PUB-29099947
Indexing hint: Randomized controlled trial · 2013
Mannstadt et al. 2013The lancet. Diabetes & endocrinologycited by 176
PMID 24622413DOI 10.1016/s2213-8587(13)70106-2PUB-24622413
4 studies on this page
PubMed tag: none · 2023
Rejnmark et al. 2023Clinical endocrinologycited by 12
PMID 35974422DOI 10.1111/cen.14813PUB-35974422
PubMed tag: none · 2022
Ayodele et al. 2022Advances in therapycited by 6
PMID 35696069PMC9309129DOI 10.1007/s12325-022-02198-yPUB-35696069
PubMed tag: none · 2022
Ayodele et al. 2022Advances in therapycited by 10
PMID 36018496PMC9525348DOI 10.1007/s12325-022-02292-1PUB-36018496
Indexing hint: Observational study · 2020
Chen et al. 2020The Journal of clinical endocrinology and metabolismcited by 28
PMID 32738041PMC7470469DOI 10.1210/clinem/dgaa490PUB-32738041
Who could join, as posted.
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