Trial · NCT00732615
Use of NPSP558 in the Treatment of Hypoparathyroidism
NCT00732615, Phase 3, Completed, Shire; results first posted 2015-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of NPSP558 in the Treatment of Hypoparathyroidism. Trials, record NCT00732615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00732615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of NPSP558 in the Treatment of Hypoparathyroidism
- NCT number
- NCT00732615
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 124 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hypoparathyroidism
- Interventions
- Placebo, NPSP558
- First posted
- 2008-08-12
- Last updated
- 2021-06-03
- Other registries' IDs
- eudract:2008-005063-34
- Results first posted
- 2015-03-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. | 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. |
| Secondary | Percentage Changes From Baseline in Daily Calcium Dose at Week 24. | 24 Weeks | The analysis of this endpoint was based on investigator prescribed data. |
| Secondary | Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24. | 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. |
| Secondary | Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24. | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. | Week 24 of dosing | Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage Changes From Baseline in Daily Calcium Dose at Week 24. | 24 Weeks | Intent to Treat (ITT) population subjects with Baseline and Week 24 data | percentage change from baseline | MEAN |
| SECONDARY | Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24. | 24 Weeks | Intent to Treat (ITT) population subjects with Baseline and Week 24 data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24. | 8 Weeks | Intent to Treat (ITT) population. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. | Placebo | 2.5 | 95% Confidence Interval 0.1 to 13.2 | percentage of participants | |
| The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. | NPSP558 | 54.8 | 95% Confidence Interval 43.5 to 65.7 | percentage of participants | |
| Percentage Changes From Baseline in Daily Calcium Dose at Week 24. | Placebo | 2.4 | Standard Deviation 38.37 | percentage change from baseline | |
| Percentage Changes From Baseline in Daily Calcium Dose at Week 24. | NPSP558 | -51.8 | Standard Deviation 45.71 | percentage change from baseline | |
| Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24. | Placebo | 6.1 | percentage of participants | ||
| Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24. | NPSP558 | 43.0 | percentage of participants | ||
| Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24. | Placebo | 37.5 | percentage of participants | ||
| Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24. | NPSP558 | 34.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | STARTED | NPSP558 | 84 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | COMPLETED | NPSP558 | 79 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | NPSP558 | 5 |
Source ClinicalTrials.gov
Adverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Paraesthesia | Nervous system disorders | Placebo | 10 | 40 | 16 |
| other | Paraesthesia | Nervous system disorders | NPSP558 | 30 | 84 | 69 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | Placebo | 9 | 40 | 10 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | NPSP558 | 33 | 84 | 54 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Placebo | 12 | 40 | 21 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | NPSP558 | 25 | 84 | 41 |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 40 | 9 |
| other | Nausea | Gastrointestinal disorders | NPSP558 | 17 | 84 | 35 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 2 | 40 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | NPSP558 | 8 | 84 | 8 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | NPSP558 | ||
| Total, other adverse events | Placebo | 38 | 40 |
| Total, other adverse events | NPSP558 | 69 | 84 |
| Total, serious adverse events | Placebo | 4 | 40 |
| Total, serious adverse events | NPSP558 | 9 | 84 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NPSP558 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00732615
GET https://conductscience.org/api/trials/v1/NCT00732615/events?page=2