Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH(1-84)] in healthy postmenopausal volunteers.

Schwietert HR, Groen EW, Sollie FA, Jonkman JH

Clinical pharmacology and therapeutics1 Mar 1997Cited by 35 (Europe PMC)

PMID9084461DOI10.1016/s0009-9236(97)90169-7PepBankPUB-09084461

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) increased serum ionized calcium dose dependently, approximately 0.15 mmol/L at doses > 0.2 microgram.kg-1.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) increased serum ionized calcium dose dependently.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseSerum ionized calcium
Study
n: not reported in source
Outcome group
Bone and joint · Endocrine and hormones
Studied dose
0.02 to 2.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Measurements
Serum ionized calcium increase
≈ 0.15 mmol/L
dose levels > 0.2 microgram.kg-1
Source sentences
Summary
In the lower dose range (0.02 to 2.0 micrograms.kg-1), serum ionized and total calcium concentrations increased dose dependently, with approximately 0.15 mmol/L for dose levels > 0.2 microgram.kg-1 and > 1.5 micrograms.kg-1, respectively,
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446101
02HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) increased serum total calcium dose dependently, approximately 0.15 mmol/L at doses > 1.5 micrograms.kg-1.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) increased serum total calcium dose dependently.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseSerum total calcium
Study
n: not reported in source
Outcome group
Bone and joint · Endocrine and hormones
Studied dose
0.02 to 2.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Measurements
Serum total calcium increase
≈ 0.15 mmol/L
dose levels > 1.5 micrograms.kg-1
Source sentences
Summary
In the lower dose range (0.02 to 2.0 micrograms.kg-1), serum ionized and total calcium concentrations increased dose dependently, with approximately 0.15 mmol/L for dose levels > 0.2 microgram.kg-1 and > 1.5 micrograms.kg-1, respectively,
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446102
03HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, higher rhPTH(1-84) doses produced biphasic serum calcium concentration-time profiles.
In plain wordsIn healthy postmenopausal volunteers, higher rhPTH(1-84) doses produced two-phase serum calcium profiles.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableHigh-dose calcium concentration-time profiles
Study
n: not reported in source
Outcome group
Bone and joint · Endocrine and hormones
Studied dose
2.0 to 5.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
unlike the higher dose range (2.0 to 5.0 micrograms.kg-1), for which concentration-time profiles clearly exhibited a biphasic pattern.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446103
04HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) increased urinary calcium/creatinine ratios in the 12- to 24-hour and 24- to 36-hour collections.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) increased the urinary calcium/creatinine ratio.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseUrinary calcium/creatinine ratio
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
>2.5 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
Urine evaluation revealed an increase in both calcium/ creatinine and phosphate/creatinine ratios, the former appearing in the 12- to 24-hour and 24- to 36-hour collections for doses > 2.5 micrograms.kg-1 and the latter in the 0- to 12-hour collection for doses > or = 1.5 micrograms.kg-1.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446104
05HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) increased urinary phosphate/creatinine ratios in the 0- to 12-hour collection.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) increased the urinary phosphate/creatinine ratio.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseUrinary phosphate/creatinine ratio
Study
n: not reported in source
Outcome group
Kidney function · Kidney and urinary
Studied dose
> or = 1.5 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
Urine evaluation revealed an increase in both calcium/ creatinine and phosphate/creatinine ratios, the former appearing in the 12- to 24-hour and 24- to 36-hour collections for doses > 2.5 micrograms.kg-1 and the latter in the 0- to 12-hour collection for doses > or = 1.5 micrograms.kg-1.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446105
06HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) produced no consistent change in urinary deoxypyridinoline excretion.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) did not consistently change this marker of bone resorption.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeUrinary deoxypyridinoline excretion
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.02 to 5.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
Urinary deoxypyridinoline excretion was used as a biochemical marker of bone resorption, but no consistent changes were found.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446106
07HumanNon-randomized trialActivity measurement
In healthy postmenopausal volunteers, rhPTH(1-84) increased urinary cyclic adenosine monophosphate in the 0- to 12-hour collection.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) increased urinary cyclic adenosine monophosphate.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseUrinary cyclic adenosine monophosphate
Study
n: not reported in source
Outcome group
Receptor activity and mechanism · Kidney and urinary
Studied dose
> or = 1.5 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
Urinary cyclic adenosine monophosphate excretion, which is an indirect measure of PTH(1-84) action on the kidney, showed a clear increase in the 0- to 12-hour urine collection for doses > or = 1.5 micrograms.kg-1.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446107
08HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal volunteers, rhPTH(1-84) serum concentrations peaked about 5 to 10 minutes and 1 1/2 to 2 hours after administration.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) produced two serum concentration peaks after administration.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSerum concentration peaks
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.02 to 5.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Measurements
Time to first serum PTH(1-84) peak
5 to 10 minutes
after administration
Time to second serum PTH(1-84) peak
1.5 to 2 hours
after administration
Source sentences
Summary
As for ionized and total calcium, serum concentration-time curves of PTH(1-84) exhibited a double-peak profile, the first peak appearing about 5 to 10 minutes after administration and the second peak occurring about 1 1/2 to 2 hours after administration.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446108
09HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal volunteers, rhPTH(1-84) had a serum terminal half-life of approximately 2 1/2 hours.
In plain wordsIn healthy postmenopausal volunteers, rhPTH(1-84) had a terminal half-life of approximately 2 1/2 hours.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTerminal half-life
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.02 to 5.0 micrograms.kg-1 · subcutaneous · single doseAs given in this study (human).
Measurements
Serum terminal half-life of PTH(1-84)
≈ 2.5 hours
single-dose subcutaneous rhPTH(1-84)
Source sentences
Summary
Serum terminal half-life of PTH(1-84) was approximately 2 1/2 hours.
1 context sentence(design, population, supporting numbers)
Summary · context
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-dose subcutaneous administration of rhPTH(1-84) or placebo to 32 healthy postmenopausal volunteers (dose range, 0.02 to 5.0 micrograms.kg-1).
Report a problemFND-0908446109

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

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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