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Study · Randomized controlled trial · n = 129 · 2014

6 results

Efficacy and safety of oral recombinant calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial.

Binkley N, Bone H, Gilligan JP, Krause DS

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA16 Jul 2014Cited by 23 (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: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, calcitonin increased lumbar spine BMD significantly more than placebo.

    In plain wordsIn postmenopausal women with low bone mass, calcitonin increased spine bone density significantly more than placebo.

    Outcome
    IncreaseLumbar spine BMD versus placebo
    Study

    n = 129

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Calcitonin recipients experienced a significant increase from baseline in lumbar spine BMD; the difference compared with placebo was significant.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low bone mass, CTx-1 was suppressed with calcitonin but not placebo.

    In plain wordsIn postmenopausal women with low bone mass, calcitonin suppressed CTx-1, while placebo did not.

    Outcome
    DecreaseCTx-1 suppression
    Study

    n = 129

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    CTx-1 was suppressed in calcitonin recipients but not in placebo subjects.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In postmenopausal women with low bone mass, calcitonin and placebo had comparable overall safety profiles.

    In plain wordsIn postmenopausal women with low bone mass, calcitonin and placebo had comparable overall safety profiles.

    Outcome
    Not applicableOverall safety profile
    Study

    n = 129

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal AEs were common, but the overall safety profile was comparable between groups.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.
  4. 04HumanNon-randomized trialEfficacy outcome

    In postmenopausal women with low bone mass, calcitonin significantly increased lumbar spine BMD from baseline.

    In plain wordsIn postmenopausal women with low bone mass, calcitonin significantly increased spine bone density from baseline.

    Outcome
    IncreaseLumbar spine BMD change
    Study

    n = 86

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Calcitonin recipients experienced a significant increase from baseline in lumbar spine BMD; the difference compared with placebo was significant.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.
  5. 05HumanNon-randomized trialEfficacy outcome

    In postmenopausal women with low bone mass, bedtime calcitonin dosing was equally effective as dosing with dinner.

    In plain wordsIn postmenopausal women with low bone mass, bedtime calcitonin dosing was equally effective as dosing with dinner.

    Outcome
    Not applicableEfficacy by dosing time
    Study

    n: not reported in source

    Comparator
    Dosing with dinner
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Dosing at bedtime or with dinner was equally effective.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.
  6. 06HumanNon-randomized trialSafety outcome

    In postmenopausal women with low bone mass, gastrointestinal adverse events were common during the calcitonin trial.

    In plain wordsIn postmenopausal women with low bone mass, gastrointestinal adverse events were common during the calcitonin trial.

    Outcome
    Direction not reportedGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 1 yearAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal AEs were common, but the overall safety profile was comparable between groups.
    2 context sentences
    Summary · context
    Treatment-naïve women were randomized to receive oral recombinant salmon calcitonin tablets or placebo once daily for 1 year.
    Summary · context
    One hundred twenty-nine women in the USA were randomized, 86 to calcitonin and 43 to placebo.

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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