Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin.

Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C

BMC clinical pharmacology4 Dec 2008Cited by 40 (Europe PMC)

PMID19055791PMCIDPMC2611964DOI10.1186/1472-6904-8-12PepBankPUB-19055791

Summary

BackgroundBone resorption displays marked diurnal variation. Reversible inhibition of bone resorption may result in best possible efficacy when bone resorption peaks. The aim of the study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral salmon calcitonin (sCT) and the effect of timing of drug intake.MethodsThe study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women. Totally 81 subjects were included, aimed at investigation of a morning dose given at 8:00 (n = 42), a pre-dinner dose given at 17:00 (n = 20), and an evening dose given at 22:00 (n = 19). Plasma sCT concentrations and bone resorption (C-terminal-telopeptide of collagen type I (CTX-I)) was assessed.ResultsMorning and pre-dinner dosing led to comparable concentration of sCT of 45 pg/ml, whereas there was a tendency towards lower Cmax for the evening dosing having a mean of 24 pg/ml. The maximum difference from placebo was observed 1 to 3 hours post-dose with a 40 to 50% suppression consequent to morning dose, and about 75% suppression after pre-dinner and evening dose, due to the increase bone resorption as a result of circadian variation.ConclusionThe study suggests that orally administered 0.8 mg of salmon calcitonin was effective in suppression of serum CTX irrespective of time of dosing. The pre-dinner dosing resulted in optimum efficacy response corresponding to an overall suppression of bone resorption by 25%.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

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

01HumanRandomized controlled trialPharmacokinetics
In healthy postmenopausal women, morning salmon calcitonin dosing produced a concentration of 45 pg/ml, comparable to pre-dinner dosing.
In plain wordsIn postmenopausal women, morning salmon calcitonin concentration was 45 pg/ml, comparable to pre-dinner dosing.
Peptide
Calcitonin-salmon
Outcome
Not applicableMorning calcitonin concentration
Study
n = 42
Comparator
Pre-dinner dosing
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Concentration
45 pg/ml
morning
Source sentences
Summary
Morning and pre-dinner dosing led to comparable concentration of sCT of 45 pg/ml, whereas there was a tendency towards lower Cmax for the evening dosing having a mean of 24 pg/ml.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579101
02HumanRandomized controlled trialEfficacy outcome
In healthy postmenopausal women, morning salmon calcitonin suppressed bone resorption by 40 to 50% versus placebo, maximally 1 to 3 hours post-dose.
In plain wordsIn postmenopausal women, morning salmon calcitonin suppressed bone resorption by 40 to 50% compared with placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseMorning CTX-I suppression
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Suppression
40 to 50%
morning versus placebo
Source sentences
Summary
The maximum difference from placebo was observed 1 to 3 hours post-dose with a 40 to 50% suppression consequent to morning dose, and about 75% suppression after pre-dinner and evening dose, due to the increase bone resorption as a result of circadian variation.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579104
03HumanRandomized controlled trialPharmacokinetics
In healthy postmenopausal women, pre-dinner salmon calcitonin dosing produced a concentration of 45 pg/ml, comparable to morning dosing.
In plain wordsIn postmenopausal women, pre-dinner salmon calcitonin concentration was 45 pg/ml, comparable to morning dosing.
Peptide
Calcitonin-salmon
Outcome
Not applicablePre-dinner calcitonin concentration
Study
n = 20
Comparator
Morning dosing
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Concentration
45 pg/ml
pre-dinner
Source sentences
Summary
Morning and pre-dinner dosing led to comparable concentration of sCT of 45 pg/ml, whereas there was a tendency towards lower Cmax for the evening dosing having a mean of 24 pg/ml.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579102
04HumanRandomized controlled trialEfficacy outcome
In healthy postmenopausal women, pre-dinner salmon calcitonin suppressed bone resorption by about 75% versus placebo, maximally 1 to 3 hours post-dose.
In plain wordsIn postmenopausal women, pre-dinner salmon calcitonin suppressed bone resorption by about 75% compared with placebo.
Peptide
Calcitonin-salmon
Outcome
DecreasePre-dinner CTX-I suppression
Study
n = 20
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Suppression
≈ 75%
pre-dinner versus placebo
Source sentences
Summary
The maximum difference from placebo was observed 1 to 3 hours post-dose with a 40 to 50% suppression consequent to morning dose, and about 75% suppression after pre-dinner and evening dose, due to the increase bone resorption as a result of circadian variation.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579105
05HumanRandomized controlled trialPharmacokinetics
In healthy postmenopausal women, evening salmon calcitonin dosing tended toward lower Cmax, with a mean of 24 pg/ml.
In plain wordsIn postmenopausal women, evening salmon calcitonin tended toward lower peak concentration than morning and pre-dinner dosing.
Peptide
Calcitonin-salmon
Outcome
DecreaseEvening Cmax
Study
n = 19
Comparator
Morning and pre-dinner dosing
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Cmax
24 pg/ml
evening
Source sentences
Summary
Morning and pre-dinner dosing led to comparable concentration of sCT of 45 pg/ml, whereas there was a tendency towards lower Cmax for the evening dosing having a mean of 24 pg/ml.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579103
06HumanRandomized controlled trialEfficacy outcome
In healthy postmenopausal women, evening salmon calcitonin suppressed bone resorption by about 75% versus placebo, maximally 1 to 3 hours post-dose.
In plain wordsIn postmenopausal women, evening salmon calcitonin suppressed bone resorption by about 75% compared with placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseEvening CTX-I suppression
Study
n = 19
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.8 mg · oralAs given in this study (human).
Measurements
Suppression
≈ 75%
evening versus placebo
Source sentences
Summary
The maximum difference from placebo was observed 1 to 3 hours post-dose with a 40 to 50% suppression consequent to morning dose, and about 75% suppression after pre-dinner and evening dose, due to the increase bone resorption as a result of circadian variation.
1 context sentence(design, population, supporting numbers)
Summary · context
The study was a randomized, double-blind, double-dummy, placebo-controlled, phase I study to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral sCT in healthy postmenopausal women.
Show in the study text Report a problemFND-1905579106

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT00411125

Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Novartisn = 86Aug 2006 to Nov 2006

Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 13 Dec 2006

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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MeSH terms

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