AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH HYPOPARATHYROIDISM.

Lakatos P, Bajnok L, Lagast H, Valkusz Z

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists18 Dec 2015Cited by 18 (Europe PMC)

PMID26684150DOI10.4158/ep15936.orPepBankPUB-26684150

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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: Publisher copyright. 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
In hypoparathyroidism, 75% met calcium and active vitamin D reduction or low-dose thresholds with normocalcemia at Week 24 (95% CI 53.3-90.2%) during PTH.
In plain wordsIn hypoparathyroidism, 75% met calcium and active vitamin D reduction or low-dose thresholds while maintaining normal blood calcium at Week 24.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicablePrimary supplement reduction endpoint
Study
n = 24
Analysis
Primary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Measurements
Patients achieving study endpoint
75%
Week 24
95% CI of proportion achieving study endpoint
53.3 to 90.2%
Week 24
Source sentences
Summary
At Week 24, 75% of patients (95% confidence interval [CI], 53.3-90.2%) achieved the study endpoint; 58% eliminated oral calcium and active vitamin D.
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was ≥50% reduction in oral calcium (or ≤500 mg/day) and active vitamin D (or calcitriol ≤0.25 μg/day or alfacalcidol ≤0.50 μg/day) with normocalcemia.
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415001
02HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, 58% eliminated oral calcium and active vitamin D with PTH.
In plain wordsIn hypoparathyroidism, 58% eliminated oral calcium and active vitamin D with PTH.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableElimination of oral calcium and active vitamin D
Study
n = 24
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Measurements
Patients who eliminated oral calcium and active vitamin D
58%
Week 24
Source sentences
Summary
At Week 24, 75% of patients (95% confidence interval [CI], 53.3-90.2%) achieved the study endpoint; 58% eliminated oral calcium and active vitamin D.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415002
03HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, urinary calcium, serum phosphate, and calcium-phosphate product decreased by Week 24 during PTH treatment.
In plain wordsIn hypoparathyroidism, urine calcium, blood phosphate, and calcium-phosphate product decreased by Week 24 during PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseUrinary calcium, serum phosphate, and calcium-phosphate product
Study
n = 24
Comparator
Baseline
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Source sentences
Summary
Urinary calcium, serum phosphate, and calcium × phosphate (Ca × P) product decreased by Week 24.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415003
04HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, mean bone turnover markers increased during PTH treatment.
In plain wordsIn hypoparathyroidism, mean bone turnover markers increased during PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseBone turnover markers
Study
n = 24
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Source sentences
Summary
Mean serum bone turnover markers increased with rhPTH(1-84).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415004
05HumanNon-randomized trialSafety outcome
In hypoparathyroidism, 92% reported treatment-emergent adverse events during PTH treatment.
In plain wordsIn hypoparathyroidism, 92% reported treatment-emergent adverse events during PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTreatment-emergent adverse events
Study
n = 24
Outcome group
Adverse events · Whole body
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Measurements
Patients with treatment-emergent adverse events
92%
24 patients
Source sentences
Summary
Treatment-emergent adverse events (TEAEs) were reported by 92% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415005
06HumanNon-randomized trialSafety outcome
In hypoparathyroidism, no serious adverse events occurred during PTH treatment.
In plain wordsIn hypoparathyroidism, no serious adverse events occurred during PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSerious adverse events
Study
n = 24
Outcome group
Adverse events · Whole body
Studied dose
50 μg/day escalated to 75 and then 100 μg/day if needed · 24 weeksAs given in this study (human).
Source sentences
Summary
No serious adverse events (AEs) occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a 24-week, open-label, flexible-dose extension study of REPLACE (REPEAT) conducted in 3 outpatient centers in Hungary.
Summary · context
Patients who previously completed or enrolled in REPLACE received 50 μg/day rhPTH(1-84), escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral calcium.
Report a problemFND-2668415006

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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 postedNCT01455181

A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

Shiren = 2419 Aug 2011 to 26 Apr 2012

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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