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Study · Randomized controlled trial · 1998

8 results

A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism.

Winer KK, Yanovski JA, Sarani B, Cutler GB Jr

The Journal of clinical endocrinology and metabolism1 Oct 1998Cited by 117 (Europe PMC)

PMID9768650 (opens in a new tab)DOI10.1210/jcem.83.10.5185 (opens in a new tab)PepBankPUB-09768650
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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 study8

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with calcium receptor mutations, once-daily PTH normalized urine calcium when serum calcium remained below normal.

    In plain wordsIn patients with calcium receptor mutations, once-daily PTH normalized urine calcium when blood calcium stayed below normal.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableUrine calcium in calcium receptor mutations
    Study

    n: not reported in source

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Once daily · subcutaneous · 14 weeksAs given in this study (human).

    Source sentences

    Summary
    In patients with calcium receptor mutations (CaR), once-daily PTH normalized urine calcium, provided that serum calcium was maintained at levels below normal range.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

Studies that did not test the peptide alone7

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

  1. 02HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, twice-daily PTH increased late-day serum calcium more effectively than once-daily PTH.

    In plain wordsIn adults with hypoparathyroidism, twice-daily PTH increased late-day blood calcium more effectively than once-daily PTH.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerum calcium during second half of day
    Study

    n = 17

    Comparator
    Once-daily PTH
    Outcome group
    Electrolyte balance · Endocrine and hormones

    Source sentences

    Summary
    During the second half of the day (12-24 h), twice-daily PTH increased serum calcium and magnesium levels more effectively than once-daily PTH.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  2. 03HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, twice-daily PTH increased late-day serum magnesium more effectively than once-daily PTH.

    In plain wordsIn adults with hypoparathyroidism, twice-daily PTH increased late-day blood magnesium more effectively than once-daily PTH.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerum magnesium during second half of day
    Study

    n = 17

    Comparator
    Once-daily PTH
    Outcome group
    Electrolyte balance · Endocrine and hormones

    Source sentences

    Summary
    During the second half of the day (12-24 h), twice-daily PTH increased serum calcium and magnesium levels more effectively than once-daily PTH.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  3. 04HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In adults with hypoparathyroidism, twice-daily PTH required a lower total daily dose than once-daily PTH.

    In plain wordsIn adults with hypoparathyroidism, twice-daily PTH required a lower total daily dose than once-daily PTH.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseTotal daily PTH dose
    Study

    n = 17

    Comparator
    Once-daily PTH
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Daily dose
    46 microg/day
    twice daily
    Daily dose
    97 microg/day
    once daily

    Source sentences

    Summary
    The total daily PTH dose was markedly reduced with the twice-daily regimen (twice daily 46+/-52 vs. once daily 97+/-60 microg/day, P < 0.001).
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  4. 05HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In patients with calcium receptor mutations, twice-daily PTH produced higher mean serum calcium than once-daily treatment.

    In plain wordsIn patients with calcium receptor mutations, twice-daily PTH produced higher average blood calcium than once-daily PTH.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseMean serum calcium in calcium receptor mutations
    Study

    n: not reported in source

    Comparator
    Once-daily PTH
    Outcome group
    Electrolyte balance · Endocrine and hormones

    Source sentences

    Summary
    However, twice-daily PTH treatment produced higher mean serum calcium in patients with CaR with no significant rise in urine calcium excretion, and with no significant differences in either serum or urine calcium levels between CaR and patients with acquired or idiopathic hypoparathyroidism.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  5. 06HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In patients with calcium receptor mutations, twice-daily PTH produced no significant rise in urinary calcium.

    In plain wordsIn patients with calcium receptor mutations, twice-daily PTH did not significantly raise urine calcium compared with once-daily PTH.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeUrine calcium with twice-daily treatment in receptor mutations
    Study

    n: not reported in source

    Comparator
    Once-daily PTH
    Outcome group
    Kidney function · Kidney and urinary

    Source sentences

    Summary
    However, twice-daily PTH treatment produced higher mean serum calcium in patients with CaR with no significant rise in urine calcium excretion, and with no significant differences in either serum or urine calcium levels between CaR and patients with acquired or idiopathic hypoparathyroidism.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  6. 07HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome

    During twice-daily PTH treatment, serum calcium did not differ significantly between calcium receptor mutation and acquired or idiopathic hypoparathyroidism groups.

    In plain wordsDuring twice-daily PTH treatment, blood calcium did not differ significantly between receptor mutation and acquired or idiopathic disease groups.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSerum calcium across etiologies
    Study

    n: not reported in source

    Comparator
    Acquired or idiopathic hypoparathyroidism
    Outcome group
    Electrolyte balance · Endocrine and hormones

    Source sentences

    Summary
    However, twice-daily PTH treatment produced higher mean serum calcium in patients with CaR with no significant rise in urine calcium excretion, and with no significant differences in either serum or urine calcium levels between CaR and patients with acquired or idiopathic hypoparathyroidism.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

  7. 08HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome

    During twice-daily PTH treatment, urine calcium did not differ significantly between calcium receptor mutation and acquired or idiopathic hypoparathyroidism groups.

    In plain wordsDuring twice-daily PTH treatment, urine calcium did not differ significantly between receptor mutation and acquired or idiopathic disease groups.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeUrine calcium across etiologies
    Study

    n: not reported in source

    Comparator
    Acquired or idiopathic hypoparathyroidism
    Outcome group
    Kidney function · Kidney and urinary

    Source sentences

    Summary
    However, twice-daily PTH treatment produced higher mean serum calcium in patients with CaR with no significant rise in urine calcium excretion, and with no significant differences in either serum or urine calcium levels between CaR and patients with acquired or idiopathic hypoparathyroidism.
    3 context sentences
    Summary · context
    To test the hypothesis that a twice-daily PTH regimen can produce more physiological control than a once-daily regimen, we performed a randomized cross-over trial, lasting 28 weeks, in 17 adult subjects with hypoparathyroidism.
    Summary · context
    Each 14-week study arm was divided into a 2-week inpatient dose-adjustment phase and a 12-week outpatient phase.
    Summary · context
    The PTH dose (given sc once daily at 0900 h or twice daily with one dose at 0900 h and the other at 2100 h) was adjusted to maintain both serum and urine calcium within, or close to, the normal range.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

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 2Results postedNCT00001304

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)n = 27Oct 1991 to Apr 2014

Hypoparathyroidism

Trial pageClinicalTrials.govUpdated 15 Dec 2015

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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