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Study · Randomized controlled trial · 2012

9 results

Effects of teriparatide in Japanese and non-Japanese populations: bridging findings on pharmacokinetics and efficacy.

Tsujimoto M, Uenaka K, Iwata A, Higashiuchi Y, Sowa H

Journal of bone and mineral metabolism21 Sept 2011Cited by 18 (Europe PMC)

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

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese and FPT participants with osteoporosis, teriparatide increased BMD compared with placebo.

    In plain wordsTeriparatide increased bone density compared with placebo in both osteoporosis studies.

    Outcome
    IncreaseBMD at 12 months
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg/day · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    With teriparatide 20 μg/day, significant increases in BMD were observed compared to placebo at 12 months in both the FPT and J-Ph3 study, and percent change and actual change in BMD were comparable between studies.
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese subjects, teriparatide analyses identified no novel safety signals.

    In plain wordsThe analyses identified no new safety signals in Japanese subjects receiving teriparatide.

    Outcome
    Direction not reportedNovel safety signals
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No novel safety signals were identified in Japanese subjects.

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. 03HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyPharmacokinetics

    In healthy postmenopausal women given single teriparatide doses, apparent AUC was up to 40% higher in Japanese than in Caucasian women.

    In plain wordsAfter single teriparatide doses, exposure was up to 40% higher in Japanese than Caucasian postmenopausal women before weight adjustment.

    Outcome
    IncreaseUnadjusted teriparatide AUC
    Study

    n: not reported in source

    Comparator
    Caucasian women
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Apparent AUC difference, Japanese versus Caucasian women
    ≤ 40%
    J-PK single-dose study, higher in Japanese women

    Source sentences

    Summary
    In J-PK, apparent teriparatide area-under-the-curve (AUC) and peak concentration (C (max)) were up to 40% higher in Japanese versus Caucasian women;
    1 context sentence
    Summary · context
    We analyzed data from single teriparatide doses in healthy Japanese and Caucasian postmenopausal women (J-PK)

    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. 04HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyPharmacokinetics

    In healthy postmenopausal women given single teriparatide doses, apparent peak concentration was up to 40% higher in Japanese than in Caucasian women.

    In plain wordsAfter single teriparatide doses, peak levels were up to 40% higher in Japanese than Caucasian postmenopausal women before weight adjustment.

    Outcome
    IncreaseUnadjusted teriparatide peak concentration
    Study

    n: not reported in source

    Comparator
    Caucasian women
    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Apparent peak concentration (Cmax) difference, Japanese versus Caucasian women
    ≤ 40%
    J-PK single-dose study, higher in Japanese women

    Source sentences

    Summary
    In J-PK, apparent teriparatide area-under-the-curve (AUC) and peak concentration (C (max)) were up to 40% higher in Japanese versus Caucasian women;
    1 context sentence
    Summary · context
    We analyzed data from single teriparatide doses in healthy Japanese and Caucasian postmenopausal women (J-PK)

    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. 05HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyPharmacokinetics

    In healthy postmenopausal women given single teriparatide doses, weight-adjusted AUC was comparable between Japanese and Caucasian women.

    In plain wordsAfter weight adjustment, teriparatide exposure was comparable in Japanese and Caucasian women.

    Outcome
    No significant changeWeight-adjusted AUC
    Study

    n: not reported in source

    Comparator
    Caucasian women
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    In J-PK, apparent teriparatide area-under-the-curve (AUC) and peak concentration (C (max)) were up to 40% higher in Japanese versus Caucasian women; however, body weight-adjusted values were comparable between populations; these findings were supported by population pharmacokinetic analyses.
    1 context sentence
    Summary · context
    We analyzed data from single teriparatide doses in healthy Japanese and Caucasian postmenopausal women (J-PK)

    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. 06HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyPharmacokinetics

    In healthy postmenopausal women given single teriparatide doses, weight-adjusted peak concentration was comparable between Japanese and Caucasian women.

    In plain wordsAfter weight adjustment, peak teriparatide levels were comparable in Japanese and Caucasian women.

    Outcome
    No significant changeWeight-adjusted peak concentration
    Study

    n: not reported in source

    Comparator
    Caucasian women
    Outcome group
    Pharmacokinetics · Pharmacology

    Source sentences

    Summary
    In J-PK, apparent teriparatide area-under-the-curve (AUC) and peak concentration (C (max)) were up to 40% higher in Japanese versus Caucasian women; however, body weight-adjusted values were comparable between populations; these findings were supported by population pharmacokinetic analyses.
    1 context sentence
    Summary · context
    We analyzed data from single teriparatide doses in healthy Japanese and Caucasian postmenopausal women (J-PK)

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

    In osteoporosis studies, percent BMD changes with teriparatide were comparable between Japanese and FPT populations.

    In plain wordsPercentage bone density changes with teriparatide were comparable between Japanese and FPT populations.

    Outcome
    No significant changeBMD percent change across studies
    Study

    n: not reported in source

    Comparator
    FPT participants
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    With teriparatide 20 μg/day, significant increases in BMD were observed compared to placebo at 12 months in both the FPT and J-Ph3 study, and percent change and actual change in BMD were comparable between studies.

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

    In osteoporosis studies, absolute BMD changes with teriparatide were comparable between Japanese and FPT populations.

    In plain wordsAbsolute bone density changes with teriparatide were comparable between Japanese and FPT populations.

    Outcome
    No significant changeAbsolute BMD change across studies
    Study

    n: not reported in source

    Comparator
    FPT participants
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    With teriparatide 20 μg/day, significant increases in BMD were observed compared to placebo at 12 months in both the FPT and J-Ph3 study, and percent change and actual change in BMD were comparable between studies.

    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. 09HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome

    In osteoporosis studies, teriparatide dose response was comparable across populations at 6 months.

    In plain wordsTeriparatide dose response was comparable across populations at 6 months.

    Outcome
    No significant changeDose response across populations
    Study

    n: not reported in source

    Comparator
    Non-Japanese population
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Dose response at 6 months was also comparable across populations.

    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.

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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