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Study · Randomized controlled trial · 2020

7 results

Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study.

Kumagai Y, Ose A, Tanaka K, Sugimoto T

Clinical pharmacology in drug development28 Mar 2019Cited by 7 (Europe PMC)

PMID30921502 (opens in a new tab)PMCIDPMC7004090 (opens in a new tab)DOI10.1002/cpdd.687 (opens in a new tab)PepBankPUB-30921502
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Japanese postmenopausal women, twice-weekly teriparatide produced half the systemic exposure of once-weekly teriparatide.

    In plain wordsIn healthy Japanese postmenopausal women, twice-weekly teriparatide produced half the drug exposure of once-weekly teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseSystemic exposure
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The systemic exposure of teriparatide acetate in the twice-weekly 28.2-μg injection was half that of the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In healthy Japanese postmenopausal women, twice-weekly and once-weekly teriparatide produced comparable bone turnover marker changes.

    In plain wordsIn healthy Japanese postmenopausal women, twice-weekly and once-weekly teriparatide produced similar changes in bone turnover markers.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeBone turnover marker changes
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Changes in bone turnover markers in the twice-weekly 28.2-μg injection were comparable to those in the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy Japanese postmenopausal women, adverse event incidence was lower with twice-weekly than once-weekly teriparatide.

    In plain wordsIn healthy Japanese postmenopausal women, adverse events occurred less often with twice-weekly than once-weekly teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseAdverse event incidence
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Adverse events · Whole body
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy Japanese postmenopausal women, nausea incidence was lower with twice-weekly than once-weekly teriparatide.

    In plain wordsIn healthy Japanese postmenopausal women, nausea occurred less often with twice-weekly than once-weekly teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseNausea incidence
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy Japanese postmenopausal women, vomiting incidence was lower with twice-weekly than once-weekly teriparatide.

    In plain wordsIn healthy Japanese postmenopausal women, vomiting occurred less often with twice-weekly than once-weekly teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseVomiting incidence
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  6. 06HumanRandomized controlled trialSafety outcome

    In healthy Japanese postmenopausal women, headache incidence was lower with twice-weekly than once-weekly teriparatide.

    In plain wordsIn healthy Japanese postmenopausal women, headaches occurred less often with twice-weekly than once-weekly teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseHeadache incidence
    Study

    n: not reported in source

    Comparator
    Once-weekly 56.5-μg teriparatide
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.
  7. 07HumanRandomized controlled trialOther

    In healthy Japanese postmenopausal women, findings with twice-weekly teriparatide were similar regardless of dosing interval.

    In plain wordsIn healthy Japanese postmenopausal women, twice-weekly teriparatide results were similar across dosing intervals.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeResults across dosing intervals
    Study

    n: not reported in source

    Comparator
    Other twice-weekly dosing intervals
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    28.2 μg twice weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Findings were similar in the twice-weekly 28.2-μg injections regardless of the dosing interval.
    2 context sentences
    Summary · context
    To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections.
    Summary · context
    A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study.

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.

  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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