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Study · Randomized controlled trial · n = 565 · 2012

11 results

A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: the Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial.

Binkley N, Bolognese M, Sidorowicz-Bialynicka A, Vally T, Trout R, Miller C, Buben CE, Gilligan JP, Krause DS

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Aug 2012Cited by 111 (Europe PMC)

PMID22437792 (opens in a new tab)DOI10.1002/jbmr.1602 (opens in a new tab)PepBankPUB-22437792
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In postmenopausal osteoporosis, approximately 80% in each oral rsCT, nasal ssCT, and placebo group experienced adverse events, mostly mild or moderate.

    In plain wordsIn women with postmenopausal osteoporosis, approximately 80% of each oral rsCT, nasal ssCT, and placebo group had adverse events.

    Peptide
    Calcitonin-salmon
    Outcome
    Not applicableAny adverse event
    Study

    n = 565

    Comparator
    Nasal ssCT and placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion with any adverse event
    ≈ 80%
    each treatment group

    Source sentences

    Summary
    Approximately 80% of subjects in each treatment group experienced an adverse event, the majority of which were mild or moderate in intensity.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  2. 02HumanRandomized controlled trialSafety outcome

    In postmenopausal osteoporosis, nearly half of women in every group reported gastrointestinal adverse events, the principal reason for premature withdrawals.

    In plain wordsIn women with postmenopausal osteoporosis, nearly half in every group had gastrointestinal adverse events, the main reason for early withdrawal.

    Peptide
    Calcitonin-salmon
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n = 565

    Comparator
    Nasal ssCT and placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal system adverse events were reported by nearly one-half of women in all treatment groups and were the principal reason for premature withdrawals.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT increased lumbar spine BMD 1.5% ± 3.2% versus 0.78% ± 2.9% with nasal ssCT.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT increased spine bone density more than nasal ssCT.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseLumbar spine BMD: oral versus nasal
    Study

    n: not reported in source

    Comparator
    Synthetic salmon calcitonin nasal spray 200 IU/day
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Measurements

    Lumbar spine BMD percent increase from baseline, mean
    1.5%
    oral rsCT
    Lumbar spine BMD percent change, SD
    3.2%
    oral rsCT
    Lumbar spine BMD percent increase from baseline, mean
    0.78%
    nasal ssCT
    Lumbar spine BMD percent change, SD
    2.9%
    nasal ssCT

    Source sentences

    Summary
    Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%).
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT increased lumbar spine BMD 1.5% ± 3.2% versus 0.5% ± 3.2% with placebo.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT increased spine bone density more than placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseLumbar spine BMD: oral versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Measurements

    Lumbar spine BMD percent increase from baseline, mean
    1.5%
    oral rsCT
    Lumbar spine BMD percent change, SD
    3.2%
    oral rsCT
    Lumbar spine BMD percent increase from baseline, mean
    0.5%
    placebo
    Lumbar spine BMD percent change, SD
    3.2%
    placebo

    Source sentences

    Summary
    Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%).
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, lumbar spine BMD change with nasal calcitonin did not differ from placebo.

    In plain wordsIn women with postmenopausal osteoporosis, spine bone density change with nasal calcitonin did not differ from placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeLumbar spine BMD: nasal versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    200 IU/day · nasal · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Lumbar spine BMD change in those receiving nasal calcitonin did not differ from placebo.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT improved trochanteric BMD more than nasal ssCT.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT improved trochanteric bone density more than nasal ssCT.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseTrochanteric BMD
    Study

    n: not reported in source

    Comparator
    Nasal ssCT
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT improved total proximal femur BMD more than nasal ssCT.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT improved total proximal femur bone density more than nasal ssCT.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseTotal proximal femur BMD
    Study

    n: not reported in source

    Comparator
    Nasal ssCT
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT reduced bone resorption markers more than nasal ssCT.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT reduced bone resorption markers more than nasal ssCT.

    Peptide
    Calcitonin-salmon
    Outcome
    DecreaseBone resorption markers versus nasal
    Study

    n: not reported in source

    Comparator
    Nasal ssCT
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, oral rsCT reduced bone resorption markers more than placebo.

    In plain wordsIn women with postmenopausal osteoporosis, oral rsCT reduced bone resorption markers more than placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    DecreaseBone resorption markers versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.2 mg/day · oral · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  10. 10HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, fewer than 10% of women experienced serious adverse events during the oral rsCT, nasal ssCT, and placebo trial.

    In plain wordsIn women with postmenopausal osteoporosis, fewer than 10% had serious adverse events during the oral rsCT, nasal ssCT, and placebo trial.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedSerious adverse events
    Study

    n = 565

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion with serious adverse event
    < 10%
    all women

    Source sentences

    Summary
    Less than 10% of women experienced a serious adverse event and no deaths occurred.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.
  11. 11HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, no deaths occurred during the oral rsCT, nasal ssCT, and placebo trial.

    In plain wordsIn women with postmenopausal osteoporosis, no deaths occurred during the oral rsCT, nasal ssCT, and placebo trial.

    Peptide
    Calcitonin-salmon
    Outcome
    Not applicableDeaths
    Study

    n = 565

    Outcome group
    Mortality · Whole body
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Less than 10% of women experienced a serious adverse event and no deaths occurred.
    1 context sentence
    Summary · context
    The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis.

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 postedNCT00959764

A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women

Tarsa Therapeutics, Inc.n = 565Jun 2009 to Feb 2011

Osteoporosis, Postmenopausal

Trial pageClinicalTrials.govUpdated 19 Nov 2013

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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