Trial reportBMC clinical pharmacology2008
Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin.
Trial report in BMC clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 49 citations in OpenAlex.
- Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016Trial
- Biochemical markers identify influences on bone and cartilage degradation in osteoarthritis--the effect of sex, Kellgren-Lawrence (KL) score, body mass index (BMI), oral salmon calcitonin (sCT) treatment and diurnal variation.BMC musculoskeletal disorders · 2010Trial
- Investigations of inter- and intraindividual relationships between exposure to oral salmon calcitonin and a surrogate marker of pharmacodynamic efficacy.European journal of clinical pharmacology · 2010Trial
- Application of circadian rhythm in osteoporosis prevention and treatment: from light, diet, and exercise to chronotherapy.Frontiers in endocrinology · 2025Review
- The specificities, influencing factors, and medical implications of bone circadian rhythms.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2024Review
- Circadian Regulation of Endocrine Fibroblast Growth Factors on Systemic Energy Metabolism.Molecular pharmacology · 2024Review
- The role of circadian rhythm in osteoporosis; a review.Frontiers in cell and developmental biology · 2022Review
- Chronobiology and Chronotherapy of Osteoporosis.JBMR plus · 2021Review
- A biomarker perspective on the acute effect of exercise with and without impact on joint tissue turnover: an exploratory randomized cross-over study.European journal of applied physiology · 2021Article
- Circadian Variation in Efficacy of Medications.Clinical pharmacology and therapeutics · 2021Review
- Calcitonin (FORTICAL, MIACALCIN) for the treatment of vertebral compression fractures.Orthopedic reviews · 2021Article
- Insights into the Role of Circadian Rhythms in Bone Metabolism: A Promising Intervention Target?BioMed research international · 2018Review
- Lessons learned from the clinical development of oral peptides.British journal of clinical pharmacology · 2015Review
- Investigating the Robustness and Diagnostic Potential of Extracellular Matrix Remodelling Biomarkers in Alkaptonuria.JIMD reports · 2015Article
- Running on time: the role of circadian clocks in the musculoskeletal system.The Biochemical journal · 2014Article
- The future of blood-based biomarkers for Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2014Review
- Oral calcitonin.Current osteoporosis reports · 2012Article
- Oral calcitonin.International journal of women's health · 2012Article
- Biochemical markers of ongoing joint damage in rheumatoid arthritis--current and future applications, limitations and opportunities.Arthritis research & therapy · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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%.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.