Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses.

Bilezikian JP, Clarke BL, Mannstadt M, Rothman J, Vokes T, Lee HM, Krasner A

Clinical therapeutics21 Sept 2017Cited by 15 (Europe PMC)

PMID28942334DOI10.1016/j.clinthera.2017.08.011PepBankPUB-28942334

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialEfficacy outcome
At week 8, 6 PTH 50-μg/d recipients (26%, 95% CI 10%-48%) met calcium ≤500 mg/d and calcitriol ≤0.25 μg/d thresholds with serum calcium maintained.
In plain wordsAt week 8, 26% receiving PTH 50 μg/d met calcium and calcitriol supplement thresholds while maintaining the specified blood calcium range.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicablePrimary supplement reduction endpoint
Study
n = 23
Analysis
Primary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients achieving primary end point
6 patients
50 μg/d group
Proportion achieving primary end point
26%
50 μg/d group
95% CI of proportion achieving primary end point
10 to 48%
50 μg/d group
Source sentences
Summary
At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%-46%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal.
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233402
02HumanNon-randomized trialEfficacy outcome
At week 8, 4 PTH 25-μg/d recipients (21%, 95% CI 6%-46%) met calcium ≤500 mg/d and calcitriol ≤0.25 μg/d thresholds with serum calcium maintained.
In plain wordsAt week 8, 21% receiving PTH 25 μg/d met calcium and calcitriol supplement thresholds while maintaining the specified blood calcium range.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicablePrimary supplement reduction endpoint
Study
n = 19
Analysis
Primary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
25 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients achieving primary end point
4 patients
25 μg/d group
Proportion achieving primary end point
21%
25 μg/d group
95% CI of proportion achieving primary end point
6 to 46%
25 μg/d group
Source sentences
Summary
At week 8, the primary end point was achieved by 4 (21%; 95% CI, 6%-46%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was the percentage of patients at week 8 with supplement reductions in calcium to ≤500 mg/d and in calcitriol to ≤0.25 μg/d, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal.
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233401
03HumanNon-randomized trialEfficacy outcome
At week 8, 6 PTH 50-μg/d recipients (26%, 95% CI 10%-48%) reduced calcium and calcitriol doses ≥50% while maintaining serum calcium.
In plain wordsAt week 8, 26% receiving PTH 50 μg/d reduced both supplement doses by at least 50% while maintaining the specified blood calcium range.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSecondary supplement reduction endpoint
Study
n = 23
Analysis
Secondary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients achieving secondary end point
6 patients
50 μg/d group
Proportion achieving secondary end point
26%
50 μg/d group
95% CI of proportion achieving secondary end point
10 to 48%
50 μg/d group
Source sentences
Summary
The secondary end point was achieved by 2 (11%; 95% CI, 1%-33%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal.
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233404
04HumanNon-randomized trialEfficacy outcome
At week 8, 2 PTH 25-μg/d recipients (11%, 95% CI 1%-33%) reduced calcium and calcitriol doses ≥50% while maintaining serum calcium.
In plain wordsAt week 8, 11% receiving PTH 25 μg/d reduced both supplement doses by at least 50% while maintaining the specified blood calcium range.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSecondary supplement reduction endpoint
Study
n = 19
Analysis
Secondary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
25 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients achieving secondary end point
2 patients
25 μg/d group
Proportion achieving secondary end point
11%
25 μg/d group
95% CI of proportion achieving secondary end point
1 to 33%
25 μg/d group
Source sentences
Summary
The secondary end point was achieved by 2 (11%; 95% CI, 1%-33%) and 6 (26%; 95% CI, 10%-48%) of the patients receiving 25 and 50 μg/d of rhPTH(1-84), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The secondary end point was the percentage of patients at week 8 with a ≥50% reduction in calcium and calcitriol doses, while maintaining serum calcium levels between 1.875 mmol/L and the upper limit of normal.
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233403
05HumanNon-randomized trialSafety outcome
In hypoparathyroidism, 17 patients (74%) receiving PTH 50 μg/d reported treatment-emergent adverse events.
In plain wordsIn hypoparathyroidism, 74% receiving PTH 50 μg/d reported treatment-emergent adverse events.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTreatment-emergent adverse events
Study
n = 23
Outcome group
Adverse events · Whole body
Studied dose
50 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients with treatment-emergent adverse events
17 patients
50 μg/d group
Proportion with treatment-emergent adverse events
74%
50 μg/d group
Source sentences
Summary
Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group.
1 context sentence(design, population, supporting numbers)
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233406
06HumanNon-randomized trialSafety outcome
In hypoparathyroidism, 11 patients (58%) receiving PTH 25 μg/d reported treatment-emergent adverse events.
In plain wordsIn hypoparathyroidism, 58% receiving PTH 25 μg/d reported treatment-emergent adverse events.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTreatment-emergent adverse events
Study
n = 19
Outcome group
Adverse events · Whole body
Studied dose
25 μg/d · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Patients with treatment-emergent adverse events
11 patients
25 μg/d group
Proportion with treatment-emergent adverse events
58%
25 μg/d group
Source sentences
Summary
Treatment-emergent adverse events were reported by 11 (58%) patients in the 25-μg group and 17 (74%) patients in the 50-μg group.
1 context sentence(design, population, supporting numbers)
Summary · context
RELAY was a dose-blinded, multicenter, 8-week study of patients with hypoparathyroidism randomized to fixed 25- or 50-μg/d doses of subcutaneous rhPTH(1-84).
Report a problemFND-2894233405

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01268098

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

Shiren = 429 Feb 2011 to 11 Nov 2011

Hypoparathyroidism

Trial page ClinicalTrials.govUpdated 11 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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