Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study.

Mannstadt M, Clarke BL, Vokes T, Brandi ML, Ranganath L, Fraser WD, Lakatos P, Bajnok L, Garceau R, Mosekilde L, Lagast H, Shoback D, Bilezikian JP

The lancet. Diabetes & endocrinology7 Oct 2013Cited by 176 (Europe PMC)

PMID24622413DOI10.1016/s2213-8587(13)70106-2PepBankPUB-24622413

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CorrectedReported by Europe PMC

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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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with hypoparathyroidism, rhPTH(1-84) increased week-24 response versus placebo: ≥50% reductions in calcium and active vitamin D doses with maintained serum calcium.
In plain wordsIn adults with hypoparathyroidism, more rhPTH(1-84) recipients than placebo recipients reduced both supplements by at least 50% while maintaining blood calcium.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePrimary composite response at week 24
Study
n = 134
Comparator
Placebo
Analysis
Primary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
50 μg per day, titrated to 75 μg or 100 μg · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Responders
48 patients
rhPTH(1-84)
Response
53%
rhPTH(1-84)
Responders
1 patient
placebo
Response
2%
placebo
Percentage difference
51.1%
between groups
95% CI
39.9 to 62.3%
percentage difference
p
< 0.0001
between groups
Source sentences
Summary
48 (53%) patients in the rhPTH(1-84) group achieved the primary endpoint compared with one (2%) patient in the placebo group (percentage difference 51.1%, 95% CI 39.9-62.3; p<0.0001).
4 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the proportion of patients at week 24 who achieved a 50% or greater reduction from baseline in their daily dose of oral calcium and active vitamin D while maintaining a serum calcium concentration greater than or the same as baseline concentrations and less than or equal to…
Summary · context
In this double-blind, placebo-controlled, randomised phase 3 study (REPLACE), we recruited patients with hypoparathyroidism (≥ 18 months duration) aged 18-85 years from 33 sites in eight countries.
Summary · context
After an optimisation period, during which calcium and active vitamin D doses were adjusted to achieve consistent albumin-corrected serum calcium, patients were randomly assigned (2:1) via an interactive voice response system to 50 μg per day of rhPTH(1-84) or placebo for 24 weeks.
Summary · context
Active vitamin D and calcium were progressively reduced, while rhPTH(1-84) could be titrated up from 50 μg to 75 μg and then 100 μg (weeks 0-5).
Report a problemFND-2462241301
02HumanRandomized controlled trialSafety outcome
In adults with hypoparathyroidism, six rhPTH(1-84) patients and seven placebo patients discontinued before study end.
In plain wordsIn adults with hypoparathyroidism, six rhPTH(1-84) patients and seven placebo patients discontinued before study end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseDiscontinuation before study end
Study
n = 134
Comparator
Placebo
Outcome group
Adverse events · Endocrine and hormones
Studied dose
50 μg per day, titrated to 75 μg or 100 μg · subcutaneousAs given in this study (human).
Measurements
Discontinuations
6 patients
rhPTH(1-84)
Discontinuations
7 patients
placebo
Source sentences
Summary
Six patients in the rhPTH(1-84) group and seven in the placebo group discontinued before study end.
3 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, randomised phase 3 study (REPLACE), we recruited patients with hypoparathyroidism (≥ 18 months duration) aged 18-85 years from 33 sites in eight countries.
Summary · context
After an optimisation period, during which calcium and active vitamin D doses were adjusted to achieve consistent albumin-corrected serum calcium, patients were randomly assigned (2:1) via an interactive voice response system to 50 μg per day of rhPTH(1-84) or placebo for 24 weeks.
Summary · context
Active vitamin D and calcium were progressively reduced, while rhPTH(1-84) could be titrated up from 50 μg to 75 μg and then 100 μg (weeks 0-5).
Report a problemFND-2462241302
03HumanRandomized controlled trialSafety outcome
In adults with hypoparathyroidism, adverse events affected 93% with rhPTH(1-84) versus 100% with placebo, described as similar proportions.
In plain wordsIn adults with hypoparathyroidism, adverse-event proportions were described as similar with rhPTH(1-84) and placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseAt least one adverse event (corrected counts)
Study
n = 134
Comparator
Placebo
Outcome group
Adverse events · Endocrine and hormones
Studied dose
50 μg per day, titrated to 75 μg or 100 μg · subcutaneousAs given in this study (human).
Measurements
Patients with adverse events
84 patients
rhPTH(1-84)
Adverse events
93%
rhPTH(1-84)
Patients with adverse events
44 patients
placebo
Adverse events
100%
placebo
Source sentences
Summary
The proportions of patients who had at least one adverse event were similar between groups (84 [93%] patients in the rhPTH[1-84] group vs 44 [100%] patients in the placebo group)
3 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, randomised phase 3 study (REPLACE), we recruited patients with hypoparathyroidism (≥ 18 months duration) aged 18-85 years from 33 sites in eight countries.
Summary · context
After an optimisation period, during which calcium and active vitamin D doses were adjusted to achieve consistent albumin-corrected serum calcium, patients were randomly assigned (2:1) via an interactive voice response system to 50 μg per day of rhPTH(1-84) or placebo for 24 weeks.
Summary · context
Active vitamin D and calcium were progressively reduced, while rhPTH(1-84) could be titrated up from 50 μg to 75 μg and then 100 μg (weeks 0-5).
Report a problemFND-2462241303
04HumanRandomized controlled trialSafety outcome
In adults with hypoparathyroidism, serious adverse events affected 11% with rhPTH(1-84) versus 9% with placebo, described as similar proportions.
In plain wordsIn adults with hypoparathyroidism, serious adverse-event proportions were described as similar with rhPTH(1-84) and placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseSerious adverse events
Study
n = 134
Comparator
Placebo
Outcome group
Adverse events · Endocrine and hormones
Studied dose
50 μg per day, titrated to 75 μg or 100 μg · subcutaneousAs given in this study (human).
Measurements
Serious adverse events
10 patients
rhPTH(1-84)
Serious adverse events
11%
rhPTH(1-84)
Serious adverse events
4 patients
placebo
Serious adverse events
9%
placebo
Source sentences
Summary
The proportions of patients with serious adverse events were also similar between the rhPTH(1-84) group (ten [11%] patients) and the placebo group (four [9%] patients).
3 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, randomised phase 3 study (REPLACE), we recruited patients with hypoparathyroidism (≥ 18 months duration) aged 18-85 years from 33 sites in eight countries.
Summary · context
After an optimisation period, during which calcium and active vitamin D doses were adjusted to achieve consistent albumin-corrected serum calcium, patients were randomly assigned (2:1) via an interactive voice response system to 50 μg per day of rhPTH(1-84) or placebo for 24 weeks.
Summary · context
Active vitamin D and calcium were progressively reduced, while rhPTH(1-84) could be titrated up from 50 μg to 75 μg and then 100 μg (weeks 0-5).
Report a problemFND-2462241309

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 postedNCT00732615

Use of NPSP558 in the Treatment of Hypoparathyroidism

Shiren = 12418 Dec 2008 to 28 Sept 2011

Hypoparathyroidism

Trial page ClinicalTrials.govUpdated 3 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 · status corrected
Version 1
27 Oct 2026, 16:37 UTC
First added · status corrected · source update from Europe PMC

Subjects

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