Skip to content

Study · Randomized controlled trial · n = 432 · 2017

7 results

Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.

Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L and 10 more

Show all authors

Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A

Lancet (London, England)26 Jul 2017Cited by 360 (Europe PMC)

PMID28755782 (opens in a new tab)DOI10.1016/s0140-6736(17)31613-6 (opens in a new tab)PepBankPUB-28755782
Publisher pagePubMedAsk about this study
Jump to 7 results

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 study7

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis after bisphosphonates, teriparatide produced lower total hip BMD changes than romosozumab through 12 months.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, hip bone density changed less favorably with teriparatide than romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseTotal hip areal BMD
    Study

    n = 415

    Comparator
    Romosozumab
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Mean change in total hip areal BMD, through 12 months
    −0.6%
    teriparatide
    Mean change in total hip areal BMD, through 12 months
    2.6%
    romosozumab
    Difference in mean change (romosozumab minus teriparatide)
    3.2%
    through 12 months

    Source sentences

    Summary
    Through 12 months, the mean percentage change from baseline in total hip areal BMD was 2·6% (95% CI 2·2 to 3·0) in the romosozumab group and -0·6% (-1·0 to -0·2) in the teriparatide group; difference 3·2% (95% CI 2·7 to 3·8; p<0·0001).
    2 context sentences
    Summary · context
    206 patients in the romosozumab group and 209 in the teriparatide group were included in the primary efficacy analysis.
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  2. 02HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, nasopharyngitis was reported in fewer teriparatide than romosozumab recipients.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, nasopharyngitis was reported less often with teriparatide than romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseNasopharyngitis
    Study

    n = 432

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Respiratory
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Nasopharyngitis
    10%
    teriparatide
    Nasopharyngitis
    13%
    romosozumab

    Source sentences

    Summary
    The most frequently reported adverse events were nasopharyngitis (28 [13%] of 218 in the romosozumab group vs 22 [10%] of 214 in the teriparatide group), hypercalcaemia (two [<1%] vs 22 [10%]), and arthralgia (22 [10%] vs 13 [6%]).
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  3. 03HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, hypercalcaemia was reported in more teriparatide than romosozumab recipients.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, high blood calcium was reported more often with teriparatide than romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseHypercalcaemia
    Study

    n = 432

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Hypercalcaemia
    10%
    teriparatide
    Hypercalcaemia
    < 1%
    romosozumab

    Source sentences

    Summary
    The most frequently reported adverse events were nasopharyngitis (28 [13%] of 218 in the romosozumab group vs 22 [10%] of 214 in the teriparatide group), hypercalcaemia (two [<1%] vs 22 [10%]), and arthralgia (22 [10%] vs 13 [6%]).
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  4. 04HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, arthralgia was reported in fewer teriparatide than romosozumab recipients.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, joint pain was reported less often with teriparatide than romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseArthralgia
    Study

    n = 432

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Musculoskeletal
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Arthralgia
    6%
    teriparatide
    Arthralgia
    10%
    romosozumab

    Source sentences

    Summary
    The most frequently reported adverse events were nasopharyngitis (28 [13%] of 218 in the romosozumab group vs 22 [10%] of 214 in the teriparatide group), hypercalcaemia (two [<1%] vs 22 [10%]), and arthralgia (22 [10%] vs 13 [6%]).
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  5. 05HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, adverse event frequencies were generally balanced between teriparatide and romosozumab.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, overall side effect frequencies were generally similar with teriparatide and romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeAdverse event frequency
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    The frequency of adverse events was generally balanced between treatment groups.
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  6. 06HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, serious adverse events were numerically more frequent with teriparatide than romosozumab, without treatment-related events.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, serious side effects were numerically more frequent with teriparatide than romosozumab, without treatment-related events.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerious adverse events
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Serious adverse events
    11%
    teriparatide
    Serious adverse events
    8%
    romosozumab

    Source sentences

    Summary
    Serious adverse events were reported in 17 (8%) patients on romosozumab and in 23 (11%) on teriparatide; none were judged treatment related.
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).
  7. 07HumanRandomized controlled trialSafety outcome

    In postmenopausal women with osteoporosis after bisphosphonates, adverse events led to withdrawal more often with teriparatide than romosozumab.

    In plain wordsIn postmenopausal women with osteoporosis after bisphosphonates, side effects led to withdrawal more often with teriparatide than romosozumab.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseAdverse events leading to withdrawal
    Study

    n: not reported in source

    Comparator
    Romosozumab
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg once daily · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Adverse events leading to withdrawal
    6%
    teriparatide
    Adverse events leading to withdrawal
    3%
    romosozumab

    Source sentences

    Summary
    There were six (3%) patients in the romosozumab group compared with 12 (6%) in the teriparatide group with adverse events leading to investigational product withdrawal.
    1 context sentence
    Summary · context
    Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 μg once daily).

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 3Results postedNCT01796301

An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

Amgenn = 43631 Jan 2013 to 14 May 2015

Postmenopausal Osteoporosis

Trial pageClinicalTrials.govUpdated 29 Nov 2022

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.

Publication types

PepBank is a research reference. Talk to a doctor before you use any peptide.