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Study · Randomized controlled trial · n = 553 · 2019

4 results

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

Sugimoto T, Shiraki M, Fukunaga M, Kishimoto H, Hagino H, Sone T, Nakano T, Ito M, Yoshikawa H, Minamida T, Tsuruya Y, Nakamura T

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA8 Aug 2019Cited by 29 (Europe PMC)

PMID31392401 (opens in a new tab)PMCIDPMC6811384 (opens in a new tab)DOI10.1007/s00198-019-05111-6 (opens in a new tab)PepBankPUB-31392401
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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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with osteoporosis, twice-weekly teriparatide produced greater lumbar spine BMD gains than once-weekly teriparatide and met non-inferiority criteria.

    In plain wordsIn patients with osteoporosis, twice-weekly teriparatide met non-inferiority criteria against once-weekly teriparatide for spine bone density.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine BMD change
    Study

    n = 553

    Comparator
    Teriparatide 56.5 μg once weekly
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    28.2 μg twice weekly · 48 weeksAs given in this study (human).

    Measurements

    BMD change
    7.3%
    twice weekly
    BMD change
    5.9%
    once weekly
    Difference in BMD change
    1.3%
    twice weekly minus once weekly

    Source sentences

    Summary
    The percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%).
    3 context sentences
    Summary · context
    Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (- 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated.
    Summary · context
    A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan.
    Summary · context
    Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276).
  2. 02HumanRandomized controlled trialSafety outcome

    In patients with osteoporosis, adverse drug reactions were less frequent with twice-weekly than once-weekly teriparatide.

    In plain wordsIn patients with osteoporosis, twice-weekly teriparatide caused fewer adverse drug reactions than once-weekly treatment.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseAdverse drug reactions
    Study

    n = 553

    Comparator
    Teriparatide 56.5 μg once weekly
    Outcome group
    Adverse events · Whole body
    Studied dose
    28.2 μg twice weekly · 48 weeksAs given in this study (human).

    Measurements

    Adverse drug reactions
    39.7%
    twice weekly
    Adverse drug reactions
    56.2%
    once weekly

    Source sentences

    Summary
    Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
    2 context sentences
    Summary · context
    A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan.
    Summary · context
    Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276).
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with osteoporosis, major adverse drug reactions were less frequent with twice-weekly than once-weekly teriparatide.

    In plain wordsIn patients with osteoporosis, twice-weekly teriparatide had fewer major adverse drug reactions than once-weekly treatment.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseMajor adverse drug reactions
    Study

    n = 553

    Comparator
    Teriparatide 56.5 μg once weekly
    Outcome group
    Adverse events · Whole body
    Studied dose
    28.2 μg twice weekly · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
    2 context sentences
    Summary · context
    A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan.
    Summary · context
    Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276).
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with osteoporosis, fewer participants discontinued twice-weekly than once-weekly teriparatide because of adverse drug reactions.

    In plain wordsIn patients with osteoporosis, fewer participants stopped twice-weekly than once-weekly teriparatide because of adverse drug reactions.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseDiscontinuation due to adverse drug reactions
    Study

    n = 553

    Comparator
    Teriparatide 56.5 μg once weekly
    Outcome group
    Adverse events · Whole body
    Studied dose
    28.2 μg twice weekly · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.
    2 context sentences
    Summary · context
    A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan.
    Summary · context
    Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276).

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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