Investigations of inter- and intraindividual relationships between exposure to oral salmon calcitonin and a surrogate marker of pharmacodynamic efficacy.

Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Christiansen C

European journal of clinical pharmacology8 Oct 2009Cited by 17 (Europe PMC)

PMID19813008DOI10.1007/s00228-009-0735-3PepBankPUB-19813008

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanObservational studyPharmacokinetics
In osteoarthritis patients, calcitonin exposure correlated weakly between days 1 and 14 at 08:00, r = 0.40.
In plain wordsIn osteoarthritis patients, calcitonin exposure correlated weakly between days 1 and 14 at 08:00.
Peptide
Calcitonin-salmon
Outcome
Not applicableWithin-person exposure correlation at 08:00
Study
n = 26
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oral · 14 daysAs given in this study (human).
Measurements
Exposure correlation r
0.4
08:00, days 1 and 14
Source sentences
Summary
In study II, exposure to sCT varied widely within the same individuals between dosing days 1 and 14, with weak correlations of r = 0.40 and 0.38 at the dose times 08:00 and 17:00, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies.
Summary · context
In study II, age-matched men or postmenopausal women with osteoarthritis received 0.8 mg oral sCT (n = 26) or placebo (n = 23) twice daily for 14 days, with dosing at 08:00 and 17:00.
Report a problemFND-1981300807
02HumanObservational studyPharmacokinetics
In osteoarthritis patients, calcitonin exposure correlated weakly between days 1 and 14 at 17:00, r = 0.38.
In plain wordsIn osteoarthritis patients, calcitonin exposure correlated weakly between days 1 and 14 at 17:00.
Peptide
Calcitonin-salmon
Outcome
Not applicableWithin-person exposure correlation at 17:00
Study
n = 26
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oral · 14 daysAs given in this study (human).
Measurements
Exposure correlation r
0.38
17:00, days 1 and 14
Source sentences
Summary
In study II, exposure to sCT varied widely within the same individuals between dosing days 1 and 14, with weak correlations of r = 0.40 and 0.38 at the dose times 08:00 and 17:00, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies.
Summary · context
In study II, age-matched men or postmenopausal women with osteoarthritis received 0.8 mg oral sCT (n = 26) or placebo (n = 23) twice daily for 14 days, with dosing at 08:00 and 17:00.
Report a problemFND-1981300808
03HumanObservational studyMechanism
In osteoarthritis patients, CTX-I responses to calcitonin were not significantly associated between days 1 and 14 at 08:00, r = 0.34.
In plain wordsIn osteoarthritis patients, CTX-I responses to calcitonin were not significantly associated between days 1 and 14 at 08:00.
Peptide
Calcitonin-salmon
Outcome
No significant changeWithin-person CTX-I response correlation at 08:00
Study
n = 26
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oral · 14 daysAs given in this study (human).
Measurements
CTX-I response correlation r
0.34
08:00, days 1 and 14
Source sentences
Summary
As expected from this finding, the intraindividual response in serum CTX-I levels was non-significantly associated on dosing days 1 and 14 (r = 0.34 and r = 0.27 at dose times 08:00 and 17:00, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies.
Summary · context
In study II, age-matched men or postmenopausal women with osteoarthritis received 0.8 mg oral sCT (n = 26) or placebo (n = 23) twice daily for 14 days, with dosing at 08:00 and 17:00.
Report a problemFND-1981300809
04HumanObservational studyMechanism
In osteoarthritis patients, CTX-I responses to calcitonin were not significantly associated between days 1 and 14 at 17:00, r = 0.27.
In plain wordsIn osteoarthritis patients, CTX-I responses to calcitonin were not significantly associated between days 1 and 14 at 17:00.
Peptide
Calcitonin-salmon
Outcome
No significant changeWithin-person CTX-I response correlation at 17:00
Study
n = 26
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oral · 14 daysAs given in this study (human).
Measurements
CTX-I response correlation r
0.27
17:00, days 1 and 14
Source sentences
Summary
As expected from this finding, the intraindividual response in serum CTX-I levels was non-significantly associated on dosing days 1 and 14 (r = 0.34 and r = 0.27 at dose times 08:00 and 17:00, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies.
Summary · context
In study II, age-matched men or postmenopausal women with osteoarthritis received 0.8 mg oral sCT (n = 26) or placebo (n = 23) twice daily for 14 days, with dosing at 08:00 and 17:00.
Report a problemFND-1981300810
05HumanObservational studyPharmacokinetics
In postmenopausal women, the between-patient coefficient of variation in calcitonin exposure after morning dosing was 22%.
In plain wordsIn postmenopausal women, calcitonin exposure varied between patients, with a coefficient of variation of 22% after morning dosing.
Peptide
Calcitonin-salmon
Outcome
Not applicableMorning exposure variability
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Exposure CV
22%
morning dose
Source sentences
Summary
The variability in exposure between patients, measured as coefficient of variation (CV), was as follows: 22% for the morning dose, 30% for the predinner dose, and 34% for the evening dose.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300801
06HumanObservational studyPharmacokinetics
In postmenopausal women, the between-patient coefficient of variation in calcitonin exposure after predinner dosing was 30%.
In plain wordsIn postmenopausal women, calcitonin exposure varied between patients, with a coefficient of variation of 30% after predinner dosing.
Peptide
Calcitonin-salmon
Outcome
Not applicablePredinner exposure variability
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Exposure CV
30%
predinner dose
Source sentences
Summary
The variability in exposure between patients, measured as coefficient of variation (CV), was as follows: 22% for the morning dose, 30% for the predinner dose, and 34% for the evening dose.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300802
07HumanObservational studyPharmacokinetics
In postmenopausal women, the between-patient coefficient of variation in calcitonin exposure after evening dosing was 34%.
In plain wordsIn postmenopausal women, calcitonin exposure varied between patients, with a coefficient of variation of 34% after evening dosing.
Peptide
Calcitonin-salmon
Outcome
Not applicableEvening exposure variability
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Exposure CV
34%
evening dose
Source sentences
Summary
The variability in exposure between patients, measured as coefficient of variation (CV), was as follows: 22% for the morning dose, 30% for the predinner dose, and 34% for the evening dose.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300803
08HumanObservational studyMechanism
In postmenopausal women, calcitonin exposure correlated with CTX-I suppression after dosing at 08:00, r = -0.74.
In plain wordsIn postmenopausal women, higher calcitonin exposure was linked to greater CTX-I suppression after dosing at 08:00.
Peptide
Calcitonin-salmon
Outcome
DecreaseExposure and CTX-I correlation at 08:00
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Pearson r
−0.74
08:00
Source sentences
Summary
In study 1, a high degree of correlation was seen between the level of exposure following a single 0.8 mg dose of sCT and suppression of serum CTX-I, with Pearson correlation coefficients of r = -0.74, -0.96, and -0.78, following doses at 08:00, 17:00, and 22:00, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300804
09HumanObservational studyMechanism
In postmenopausal women, calcitonin exposure correlated with CTX-I suppression after dosing at 17:00, r = -0.96.
In plain wordsIn postmenopausal women, higher calcitonin exposure was linked to greater CTX-I suppression after dosing at 17:00.
Peptide
Calcitonin-salmon
Outcome
DecreaseExposure and CTX-I correlation at 17:00
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Pearson r
−0.96
17:00
Source sentences
Summary
In study 1, a high degree of correlation was seen between the level of exposure following a single 0.8 mg dose of sCT and suppression of serum CTX-I, with Pearson correlation coefficients of r = -0.74, -0.96, and -0.78, following doses at 08:00, 17:00, and 22:00, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300805
10HumanObservational studyMechanism
In postmenopausal women, calcitonin exposure correlated with CTX-I suppression after dosing at 22:00, r = -0.78.
In plain wordsIn postmenopausal women, higher calcitonin exposure was linked to greater CTX-I suppression after dosing at 22:00.
Peptide
Calcitonin-salmon
Outcome
DecreaseExposure and CTX-I correlation at 22:00
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Pearson r
−0.78
22:00
Source sentences
Summary
In study 1, a high degree of correlation was seen between the level of exposure following a single 0.8 mg dose of sCT and suppression of serum CTX-I, with Pearson correlation coefficients of r = -0.74, -0.96, and -0.78, following doses at 08:00, 17:00, and 22:00, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Participants were from two randomized, double-blind, placebo-controlled studies. In study I, healthy postmenopausal women received a single dose of 0.8 mg of oral sCT or placebo at 08:00 (n = 42), 17:00 (n = 20), or at 22:00 (n = 19).
Report a problemFND-1981300806

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.

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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