Trial · NCT01268098

Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

NCT01268098, Phase 3, Completed, Shire; results first posted 2015-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY). Trials, record NCT01268098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01268098

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
NCT number: NCT01268098
Status: Completed
Phases: Phase 3
Enrollment: 42 participants, actual
Lead sponsor: Shire
Conditions: Hypoparathyroidism
Interventions: NPSP558
First posted: 2010-12-29
Last updated: 2021-06-11
Results first posted: 2015-03-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.	8 Weeks	The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
Secondary	The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.	8 Weeks	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

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.	8 Weeks	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	The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.	8 Weeks	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

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.	NPSP558 - 25 µg Dose	21.1	95% Confidence Interval 6.1 to 45.6	percentage of participants
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.	NPSP558 - 50 µg Dose	26.1	95% Confidence Interval 10.2 to 48.4	percentage of participants
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.	NPSP558 - 25 µg Dose	10.5	95% Confidence Interval 1.3 to 33.1	percentage of participants
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.	NPSP558 - 50 µg Dose	26.1	95% Confidence Interval 10.2 to 48.4	percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NPSP558 - 25 µg Dose	19
Overall Study	STARTED	NPSP558 - 50 µg Dose	23
Overall Study	COMPLETED	NPSP558 - 25 µg Dose	18
Overall Study	COMPLETED	NPSP558 - 50 µg Dose	23
Overall Study	NOT COMPLETED	NPSP558 - 25 µg Dose	1
Overall Study	NOT COMPLETED	NPSP558 - 50 µg Dose	0

Source ClinicalTrials.gov

Adverse events56

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	Paresthesia	Nervous system disorders	NPSP558 - 25 µg Dose	4	19	8
other	Paresthesia	Nervous system disorders	NPSP558 - 50 µg Dose	5	23	6
other	Headache	Nervous system disorders	NPSP558 - 25 µg Dose	1	19	1
other	Headache	Nervous system disorders	NPSP558 - 50 µg Dose	3	23	3
other	Carotid artery stenosis	Nervous system disorders	NPSP558 - 25 µg Dose	1	19	1
other	Carotid artery stenosis	Nervous system disorders	NPSP558 - 50 µg Dose	0	23	0
other	Migraine	Nervous system disorders	NPSP558 - 25 µg Dose	1	19	1
other	Migraine	Nervous system disorders	NPSP558 - 50 µg Dose	0	23	0
other	Nausea	Gastrointestinal disorders	NPSP558 - 25 µg Dose	2	19	2
other	Nausea	Gastrointestinal disorders	NPSP558 - 50 µg Dose	3	23	4

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NPSP558 - 25 µg Dose
Total, all-cause mortality	NPSP558 - 50 µg Dose
Total, other adverse events	NPSP558 - 25 µg Dose	11	19
Total, other adverse events	NPSP558 - 50 µg Dose	17	23
Total, serious adverse events	NPSP558 - 25 µg Dose	0	19
Total, serious adverse events	NPSP558 - 50 µg Dose	0	23

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28942334	DERIVED	PubMed
32738041	DERIVED	PubMed
35696069	DERIVED	PubMed
35974422	DERIVED	PubMed
36018496	DERIVED	PubMed

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 - 25 µg Dose vs NPSP558 - 50 µg Dose: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01268098

GET https://conductscience.org/api/trials/v1/NCT01268098/events?page=2

API reference For AI assistants