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Study · Randomized controlled trial · n = 4,665 · 2016

17 results

A randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D.

Henriksen K, Byrjalsen I, Andersen JR, Bihlet AR, Russo LA, Alexandersen P, Valter I, Qvist P, Lau E, Riis BJ, Christiansen C, Karsdal MA

Bone25 Jul 2016Cited by 54 (Europe PMC)

PMID27462009 (opens in a new tab)DOI10.1016/j.bone.2016.07.019 (opens in a new tab)PepBankPUB-27462009
Publisher pagePubMedAsk about this study
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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 study17

17 results from studies that gave the peptide. 17 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, SMC021 did not prevent new vertebral fractures compared with placebo.

    In plain wordsIn women with postmenopausal osteoporosis, SMC021 did not prevent new vertebral fractures compared with placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeNew vertebral fractures
    Study

    n = 4,665

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    No effect of SMC021 on preventing new vertebral fractures was observed, nor was any effect seen on new hip or non-vertebral fractures.
    2 context sentences
    Summary · context
    The primary endpoint was the proportion of patients with a new vertebral fracture.
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, SMC021 did not affect new hip fractures compared with placebo.

    In plain wordsIn women with postmenopausal osteoporosis, SMC021 did not affect new hip fractures compared with placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeNew hip fractures
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    No effect of SMC021 on preventing new vertebral fractures was observed, nor was any effect seen on new hip or non-vertebral fractures.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, SMC021 did not affect new non-vertebral fractures compared with placebo.

    In plain wordsIn women with postmenopausal osteoporosis, SMC021 did not affect new non-vertebral fractures compared with placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeNew non-vertebral fractures
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    No effect of SMC021 on preventing new vertebral fractures was observed, nor was any effect seen on new hip or non-vertebral fractures.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, lumbar spine BMD increased 1.02% (±0.12%) with SMC021 versus 0.18% (±0.12%) with placebo (p<0.0001).

    In plain wordsIn women with postmenopausal osteoporosis, SMC021 increased spine bone density more than placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseLumbar spine BMD
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Measurements

    Lumbar spine BMD increase
    1.02%
    SMC021 group, reported ±0.12%
    Lumbar spine BMD increase
    0.18%
    placebo group, reported ±0.12%
    p
    < 0.0001
    SMC021 vs placebo

    Source sentences

    Summary
    Women receiving SMC021 had a mean 1.02% (±0.12%) increase in lumbar spine bone mineral density (BMD) compared with a mean 0.18% (±0.12%) increase in the placebo group by the end of the study (p<0.0001).
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, urinary CTX-I was 15% lower with SMC021 than placebo at 12 and 24 months.

    In plain wordsIn women with postmenopausal osteoporosis, urinary CTX-I was 15% lower with SMC021 than placebo at 12 and 24 months.

    Peptide
    Calcitonin-salmon
    Outcome
    DecreaseUrinary CTX-I at 12 and 24 months
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Measurements

    Urinary CTX-I difference vs placebo
    15%
    lower with SMC021 at 12 and 24 months

    Source sentences

    Summary
    Levels of the biomarkers of bone turnover, urinary CTX-I and CTX-II, were 15% lower in the SMC021 group than in the placebo arm at 12 and 24months, but not at 36months.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, urinary CTX-II was 15% lower with SMC021 than placebo at 12 and 24 months.

    In plain wordsIn women with postmenopausal osteoporosis, urinary CTX-II was 15% lower with SMC021 than placebo at 12 and 24 months.

    Peptide
    Calcitonin-salmon
    Outcome
    DecreaseUrinary CTX-II at 12 and 24 months
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Measurements

    Urinary CTX-II difference vs placebo
    15%
    lower with SMC021 at 12 and 24 months

    Source sentences

    Summary
    Levels of the biomarkers of bone turnover, urinary CTX-I and CTX-II, were 15% lower in the SMC021 group than in the placebo arm at 12 and 24months, but not at 36months.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, urinary CTX-I was not lower with SMC021 than placebo at 36 months.

    In plain wordsIn women with postmenopausal osteoporosis, urinary CTX-I was not lower with SMC021 than placebo at 36 months.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeUrinary CTX-I at 36 months
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    Levels of the biomarkers of bone turnover, urinary CTX-I and CTX-II, were 15% lower in the SMC021 group than in the placebo arm at 12 and 24months, but not at 36months.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, urinary CTX-II was not lower with SMC021 than placebo at 36 months.

    In plain wordsIn women with postmenopausal osteoporosis, urinary CTX-II was not lower with SMC021 than placebo at 36 months.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeUrinary CTX-II at 36 months
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    Levels of the biomarkers of bone turnover, urinary CTX-I and CTX-II, were 15% lower in the SMC021 group than in the placebo arm at 12 and 24months, but not at 36months.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, quality of life did not change between SMC021 and placebo groups through month 36.

    In plain wordsIn women with postmenopausal osteoporosis, quality of life did not change between SMC021 and placebo groups through month 36.

    Peptide
    Calcitonin-salmon
    Outcome
    No significant changeQualeffo-14 quality of life
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    No change in quality of life between groups, assessed by the Qualeffo-14 questionnaire, was observed in either group between baseline and month 36.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  10. 10HumanRandomized controlled trialSafety outcome

    In postmenopausal osteoporosis, approximately 92% of each group experienced adverse events, mostly mild or moderate.

    In plain wordsIn women with postmenopausal osteoporosis, approximately 92% of both SMC021 and placebo groups had adverse events, mostly mild or moderate.

    Peptide
    Calcitonin-salmon
    Outcome
    Not applicableAny adverse event
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Measurements

    Subjects with any adverse event
    ≈ 92%
    each treatment group

    Source sentences

    Summary
    Approximately 92% of subjects in each treatment group experienced an adverse event (AE), the majority of which were mild or moderate in intensity.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  11. 11HumanRandomized controlled trialSafety outcome

    In postmenopausal osteoporosis, severe adverse event counts were low in both SMC021 and placebo groups.

    In plain wordsIn women with postmenopausal osteoporosis, severe adverse event counts were low in both SMC021 and placebo groups.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedSevere adverse events
    Study

    n = 4,665

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    The number of severe AEs was low in both groups.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  12. 12HumanRandomized controlled trialSafety outcome

    In postmenopausal osteoporosis, hot flushes were the reason for a slightly higher drop-out rate with SMC021 than placebo.

    In plain wordsIn women with postmenopausal osteoporosis, hot flushes were the reason for a slightly higher drop-out rate with SMC021 than placebo.

    Peptide
    Calcitonin-salmon
    Outcome
    IncreaseDrop-out rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs associated with SMC021 were primarily of gastrointestinal origin and included nausea, vomiting and abdominal pain, as well as hot flushes which were the reason for the slightly higher drop-out rate in the active treatment arm compared to placebo.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  13. 13HumanNon-randomized trialPharmacokinetics

    In postmenopausal osteoporosis, SMC021 exposure was confirmed, but drug levels were markedly lower than expected.

    In plain wordsIn women with postmenopausal osteoporosis, SMC021 exposure was confirmed, but drug levels were markedly lower than expected.

    Peptide
    Calcitonin-salmon
    Outcome
    DecreaseDrug exposure
    Study

    n: not reported in source

    Comparator
    Expected drug levels
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    Pharmacokinetics analysis confirmed exposure to SMC021, but the drug levels were markedly lower than expected.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  14. 14HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, nausea was associated with SMC021 treatment.

    In plain wordsIn women with postmenopausal osteoporosis, nausea was associated with SMC021 treatment.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs associated with SMC021 were primarily of gastrointestinal origin and included nausea, vomiting and abdominal pain, as well as hot flushes which were the reason for the slightly higher drop-out rate in the active treatment arm compared to placebo.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  15. 15HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, vomiting was associated with SMC021 treatment.

    In plain wordsIn women with postmenopausal osteoporosis, vomiting was associated with SMC021 treatment.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedVomiting
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs associated with SMC021 were primarily of gastrointestinal origin and included nausea, vomiting and abdominal pain, as well as hot flushes which were the reason for the slightly higher drop-out rate in the active treatment arm compared to placebo.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  16. 16HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, abdominal pain was associated with SMC021 treatment.

    In plain wordsIn women with postmenopausal osteoporosis, abdominal pain was associated with SMC021 treatment.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedAbdominal pain
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs associated with SMC021 were primarily of gastrointestinal origin and included nausea, vomiting and abdominal pain, as well as hot flushes which were the reason for the slightly higher drop-out rate in the active treatment arm compared to placebo.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.
  17. 17HumanNon-randomized trialSafety outcome

    In postmenopausal osteoporosis, hot flushes were associated with SMC021 treatment.

    In plain wordsIn women with postmenopausal osteoporosis, hot flushes were associated with SMC021 treatment.

    Peptide
    Calcitonin-salmon
    Outcome
    Direction not reportedHot flushes
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.8 mg/day · oral · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs associated with SMC021 were primarily of gastrointestinal origin and included nausea, vomiting and abdominal pain, as well as hot flushes which were the reason for the slightly higher drop-out rate in the active treatment arm compared to placebo.
    1 context sentence
    Summary · context
    A total of 4665 postmenopausal women with osteoporosis were randomized 1:1 to receive calcium and vitamin D plus either SMC021 tablets (0.8mg/d) or placebo for 36months.

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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