Safety and efficacy of a novel salmon calcitonin (sCT) technology-based oral formulation in healthy postmenopausal women: acute and 3-month effects on biomarkers of bone turnover.

Tankó LB, Bagger YZ, Alexandersen P, Devogelaer JP, Reginster JY, Chick R, Olson M, Benmammar H, Mindeholm L, Azria M, Christiansen C

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research26 Jul 2004Cited by 67 (Europe PMC)

PMID15312255DOI10.1359/jbmr.040715PepBankPUB-15312255

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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 study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, oral calcitonin reduced serum CTx by 60.8% to 81.8% from baseline versus placebo, with nadirs at 2-3 h.
In plain wordsIn postmenopausal women, oral calcitonin reduced serum bone breakdown markers more than placebo after the first dose.
Peptide
Calcitonin-salmon
Outcome
DecreaseAcute serum CTx
Study
n = 277
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Measurements
Serum CTx change from baseline
−60.8 to −81.8%
after first dose, dose-dependent, versus placebo
Time to serum CTx nadir
2 to 3 h
after drug intake
Source sentences
Summary
After the first dose, sCT evoked dose-dependent decreases in serum CTx (-60.8% to -81.8% from baseline) compared with placebo, reaching nadirs 2-3 h after drug intake, after which, gradual increases were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225502
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, the placebo-corrected predose serum CTx change at month 3 was -18.9% with 1.0 mg calcitonin (p < 0.05).
In plain wordsIn postmenopausal women, calcitonin reduced predose serum CTx more than placebo at month 3.
Peptide
Calcitonin-salmon
Outcome
DecreasePredose serum CTx at month 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
1.0 mg · oral · 3 monthsAs given in this study (human).
Measurements
Placebo-corrected predose serum CTx change
−18.9%
1.0-mg dose group, month 3
Source sentences
Summary
At month 3, the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225506
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, the placebo-corrected predose urinary CTx change at month 3 was -20.5% with 1.0 mg calcitonin (p < 0.05).
In plain wordsIn postmenopausal women, calcitonin reduced predose urinary CTx more than placebo at month 3.
Peptide
Calcitonin-salmon
Outcome
DecreasePredose urinary CTx at month 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
1.0 mg · oral · 3 monthsAs given in this study (human).
Measurements
Placebo-corrected predose urinary CTx change
−20.5%
1.0-mg dose group, month 3
Source sentences
Summary
At month 3, the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225507
04HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, other calcitonin dose groups showed no significant placebo-corrected predose serum CTx change at month 3.
In plain wordsIn postmenopausal women, other calcitonin doses did not significantly change predose serum CTx compared with placebo.
Peptide
Calcitonin-salmon
Outcome
No significant changePredose serum CTx at other doses
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
At month 3, the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225508
05HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, other calcitonin dose groups showed no significant placebo-corrected predose urinary CTx change at month 3.
In plain wordsIn postmenopausal women, other calcitonin doses did not significantly change predose urinary CTx compared with placebo.
Peptide
Calcitonin-salmon
Outcome
No significant changePredose urinary CTx at other doses
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
At month 3, the placebo-corrected changes in the pre-dose value of serum and urinary CTx were significant only in the 1.0-mg dose group (-18.9% and -20.5%, respectively, p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225509
06HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, the placebo-corrected osteocalcin change with oral calcitonin was -8.6 (p = 0.09).
In plain wordsIn postmenopausal women, osteocalcin did not change significantly with oral calcitonin compared with placebo.
Peptide
Calcitonin-salmon
Outcome
No significant changeOsteocalcin placebo-corrected change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Measurements
Placebo-corrected OC change
−8.6
month 3, placebo-corrected
P
0.09
placebo-corrected OC change
Source sentences
Summary
The placebo-corrected change in OC was -8.6 (p = 0.09), whereas the change in BSALP was -7.3 (p = 0.02).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225510
07HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, the placebo-corrected BSALP change with oral calcitonin was -7.3 (p = 0.02).
In plain wordsIn postmenopausal women, oral calcitonin reduced bone-specific alkaline phosphatase compared with placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseBSALP placebo-corrected change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Measurements
Placebo-corrected BSALP change
−7.3
month 3, placebo-corrected
P
0.02
placebo-corrected BSALP change
Source sentences
Summary
The placebo-corrected change in OC was -8.6 (p = 0.09), whereas the change in BSALP was -7.3 (p = 0.02).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225511
08HumanNon-randomized trialPharmacokinetics
In postmenopausal women, the Eligen oral salmon calcitonin formulation showed effective enteral absorption.
In plain wordsIn postmenopausal women, the Eligen oral salmon calcitonin formulation showed effective enteral absorption.
Peptide
Calcitonin-salmon
Outcome
Not applicableEnteral absorption
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
The results show (1) effective enteral absorption, (2) marked inhibition of bone resorption with minimal alteration of formation, and (3) reproducibility of responses over 3 months.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225501
09HumanNon-randomized trialEfficacy outcome
In postmenopausal women, acute osteocalcin changes with oral calcitonin were not statistically significant.
In plain wordsIn postmenopausal women, oral calcitonin did not significantly change osteocalcin after dosing.
Peptide
Calcitonin-salmon
Outcome
No significant changeAcute osteocalcin
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
The simultaneous acute changes in OC were statistically nonsignificant.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225503
10HumanNon-randomized trialSafety outcome
In postmenopausal women, mild to moderate gastrointestinal manifestations were seen with oral calcitonin, mainly in the high-dose groups.
In plain wordsIn postmenopausal women taking oral calcitonin, mild to moderate digestive symptoms were seen, mainly at high doses.
Peptide
Calcitonin-salmon
Outcome
Not applicableGastrointestinal manifestations
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
The oral formulation was well tolerated, with mild to moderate gastrointestinal and skin manifestations apparent mainly in the high-dose groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225512
11HumanNon-randomized trialSafety outcome
In postmenopausal women, mild to moderate skin manifestations were seen with oral calcitonin, mainly in the high-dose groups.
In plain wordsIn postmenopausal women taking oral calcitonin, mild to moderate skin symptoms were seen, mainly at high doses.
Peptide
Calcitonin-salmon
Outcome
Not applicableSkin manifestations
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Source sentences
Summary
The oral formulation was well tolerated, with mild to moderate gastrointestinal and skin manifestations apparent mainly in the high-dose groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225513
12HumanObservational studyActivity measurement
In postmenopausal women, serum CTx response AUC at month 1 correlated with baseline response (r = 0.78, p < 0.001).
In plain wordsIn postmenopausal women, the bone breakdown response to calcitonin at month 1 correlated with the initial response.
Peptide
Calcitonin-salmon
Outcome
Not applicableSerum CTx response reproducibility at month 1
Study
n: not reported in source
Comparator
Baseline response
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Measurements
Correlation of serum CTx AUC with baseline AUC (r)
0.78 r
month 1
Source sentences
Summary
Area under the curve (AUC) of serum CTx responses at months 1 and 3 showed strong correlation with those at baseline (both r = 0.78, p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225504
13HumanObservational studyActivity measurement
In postmenopausal women, serum CTx response AUC at month 3 correlated with baseline response (r = 0.78, p < 0.001).
In plain wordsIn postmenopausal women, the bone breakdown response to calcitonin at month 3 correlated with the initial response.
Peptide
Calcitonin-salmon
Outcome
Not applicableSerum CTx response reproducibility at month 3
Study
n: not reported in source
Comparator
Baseline response
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.15, 0.4, 1.0, or 2.5 mg daily; or 1.0 mg every other day · oral · 3 monthsAs given in this study (human).
Measurements
Correlation of serum CTx AUC with baseline AUC (r)
0.78 r
month 3
Source sentences
Summary
Area under the curve (AUC) of serum CTx responses at months 1 and 3 showed strong correlation with those at baseline (both r = 0.78, p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging clinical trial including 277 healthy postmenopausal women 55-85 years of age.
Summary · context
Women received treatment with either daily (0.15, 0.4, 1.0, or 2.5 mg) or intermittent doses (1.0 mg, every other day) of sCT combined with the delivery agent (8-[N-2-hydroxi-5-chloro-benzoyl]-amino-caprylic acid, 200 mg) or placebo for 3 months.
Report a problemFND-1531225505

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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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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