PTH(1-84) replacement therapy in hypoparathyroidism: a randomized controlled trial on pharmacokinetic and dynamic effects after 6 months of treatment.

Sikjaer T, Amstrup AK, Rolighed L, Kjaer SG, Mosekilde L, Rejnmark L

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Oct 2013Cited by 59 (Europe PMC)

PMID23649554DOI10.1002/jbmr.1964PepBankPUB-23649554

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH did not change 24-hour urinary calcium versus placebo.
In plain wordsIn hypoparathyroidism, PTH did not change 24-hour urinary calcium versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeUrinary calcium over twenty-four hours
Study
n = 38
Comparator
Placebo
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, 24-hour urinary calcium, phosphate, and magnesium did not change, although the diurnal variation in renal excretion rates changed significantly in response to treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955408
02HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH did not change 24-hour urinary phosphate versus placebo.
In plain wordsIn hypoparathyroidism, PTH did not change 24-hour urinary phosphate versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeUrinary phosphate over twenty-four hours
Study
n = 38
Comparator
Placebo
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, 24-hour urinary calcium, phosphate, and magnesium did not change, although the diurnal variation in renal excretion rates changed significantly in response to treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955409
03HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH did not change 24-hour urinary magnesium versus placebo.
In plain wordsIn hypoparathyroidism, PTH did not change 24-hour urinary magnesium versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeUrinary magnesium over twenty-four hours
Study
n = 38
Comparator
Placebo
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, 24-hour urinary calcium, phosphate, and magnesium did not change, although the diurnal variation in renal excretion rates changed significantly in response to treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955410
04HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH significantly altered diurnal renal excretion variation versus placebo.
In plain wordsIn hypoparathyroidism, PTH significantly altered daily variation in kidney mineral excretion versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Direction not reportedDiurnal renal excretion variation
Study
n = 38
Comparator
Placebo
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, 24-hour urinary calcium, phosphate, and magnesium did not change, although the diurnal variation in renal excretion rates changed significantly in response to treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955411
05HumanNon-randomized trialPharmacokinetics
In hypoparathyroidism, PTH reached a median plasma peak of 26.5 pmol/L (IQR, 20.1-42.5) 15 minutes after injection.
In plain wordsIn hypoparathyroidism, PTH blood levels peaked 15 minutes after injection.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePeak plasma PTH
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Measurements
Median peak plasma PTH
26.5 pmol/L
after injection, rhPTH(1-84)-treated patients
Interquartile range of peak plasma PTH
20.1 to 42.5 pmol/L
after injection
Time to peak plasma PTH
15 minutes
following injection
Source sentences
Summary
PTH levels rose immediately, reaching a median peak level of 26.5 (interquartile range [IQR], 20.1-42.5) pmol/L 15 minutes following injection.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955401
06HumanNon-randomized trialPharmacokinetics
In hypoparathyroidism, plasma PTH returned to predosing levels after 16 hours.
In plain wordsIn hypoparathyroidism, blood PTH returned to predose levels after 16 hours.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseReturn to predose plasma PTH
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Measurements
Time to return to predosing PTH level
16 hours
after injection
Source sentences
Summary
Thereafter, levels gradually decreased until reaching predosing levels after 16 hours, with a plasma half-life of 2.2 (1.7-2.5) hours.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955402
07HumanNon-randomized trialPharmacokinetics
In hypoparathyroidism, PTH plasma half-life was 2.2 hours, with a reported interval of 1.7-2.5 hours.
In plain wordsIn hypoparathyroidism, PTH plasma half-life was 2.2 hours.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicablePlasma PTH half-life
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Measurements
Plasma half-life of PTH
2.2 hours
rhPTH(1-84)
Plasma half-life interval as reported
1.7 to 2.5 hours
rhPTH(1-84)
Source sentences
Summary
Thereafter, levels gradually decreased until reaching predosing levels after 16 hours, with a plasma half-life of 2.2 (1.7-2.5) hours.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955403
08HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, ionized calcium rose after PTH injection with an altered diurnal rhythm.
In plain wordsIn hypoparathyroidism, blood calcium rose after PTH injection with an altered daily rhythm.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseIonized calcium rhythm
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
rhPTH(1-84) changed the diurnal rhythms of ionized calcium levels and 1,25-dihydroxyvitamin D (1,25[OH]2 D) levels, with rising levels following injection.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955404
09HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, 1,25-dihydroxyvitamin D rose after PTH injection with an altered diurnal rhythm.
In plain wordsIn hypoparathyroidism, active vitamin D rose after PTH injection with an altered daily rhythm.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseVitamin D metabolite rhythm
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Source sentences
Summary
rhPTH(1-84) changed the diurnal rhythms of ionized calcium levels and 1,25-dihydroxyvitamin D (1,25[OH]2 D) levels, with rising levels following injection.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955405
10HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, ionized calcium peaked 7.0 hours after PTH injection, with a reported interval of 5.0-10.0 hours.
In plain wordsIn hypoparathyroidism, blood calcium peaked 7.0 hours after PTH injection.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTime to peak ionized calcium
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Measurements
Time to peak ionized calcium
7 hours
after injection
Time to peak ionized calcium, interval as reported
5 to 10 hours
after injection
Source sentences
Summary
Ionized calcium peaked after 7.0 (5.0-10.0) hours.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955406
11HumanNon-randomized trialSafety outcome
In hypoparathyroidism, 71% of PTH-treated patients had asymptomatic hypercalcemia.
In plain wordsIn hypoparathyroidism, 71% of PTH-treated patients had high blood calcium without symptoms.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableAsymptomatic hypercalcemia
Study
n: not reported in source
Outcome group
Adverse events · Endocrine and hormones
Studied dose
100 µg/d · subcutaneous in the thigh · 6 monthsAs given in this study (human).
Measurements
Patients with asymptomatic hypercalcemia
71%
rhPTH(1-84)-treated patients
Source sentences
Summary
Asymptomatic hypercalcemia was present in 71% of the rhPTH(1-84)-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
we performed a 24-hour monitoring study of pharmacokinetic and pharmacodynamic effects in a group of 38 patients who had completed a 6-month randomized study on effects of treatment with a fixed rhPTH(1-84) dose of 100 µg/d or similar placebo as an add-on to conventional treatment.
Report a problemFND-2364955407

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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

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PTH(1-84) replacement therapy in hypoparathyroidism: a randomized controlled trial on pharmacokinetic and dynamic effects after 6 months of treatment.

Summary

Results from this study11

Version history

Subjects

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Keywords