ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017
Comparison of two automated assays of BTM (CTX and P1NP) and reference intervals in a Danish population.
Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07242612 (Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Pooled it
- Dimethandrolone Undecanoate, a Novel, Nonaromatizable Androgen, Increases P1NP in Healthy Men Over 28 Days.The Journal of clinical endocrinology and metabolism · 2021Trial
- Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis.Arthritis research & therapy · 2019Trial
- Bone turnover markers in the management of CKD-associated osteoporosis-a European consensus.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026Review
- Update on the role of bone turnover markers in the diagnosis and management of osteoporosis: a consensus paper from The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO), International Osteoporosis Foundation (IOF), and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Review
- Latest Advances in Structural Insights and Quantification Techniques for Type I Collagen Biomarkers: A path toward standardization?Biomarker insights · 2025Review
- Increase in lumbar spine but not distal radius bone mineral density in adults after pancreas kidney transplantation.Bone reports · 2024Article
- Changes in Collagen Type I C-Telopeptide and Procollagen Type I N-Terminal Propeptide During the Menopause Transition.The Journal of clinical endocrinology and metabolism · 2024Article
- Establishment of Reference Intervals for Bone Turnover Biomarkers in Healthy Populations in Northern China.International journal of general medicine · 2024Article
- Article
- Lipid Peroxidation as a Possible Factor Affecting Bone Resorption in Obese Subjects-Preliminary Research.International journal of molecular sciences · 2023Article
- Bone Turnover Markers: Basic Biology to Clinical Applications.Endocrine reviews · 2023Article
- Evaluation of bone metabolism-associated biomarkers in Tibet, China.Journal of clinical laboratory analysis · 2021Article
- IGFBP7 and GDF-15, but not P1NP, are associated with cardiac alterations and 10-year outcome in an elderly community-based study.BMC cardiovascular disorders · 2021Article
- Impact of Tenofovir Disoproxil-Induced Fanconi Syndrome on Bone Material Quality: A Case Report.JBMR plus · 2021Article
- A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (ß-CTX): A Report from the IFCC-IOF Committee for Bone Metabolism (C-BM).Calcified tissue international · 2021Article
- Analytical considerations and plans to standardize or harmonize assays for the reference bone turnover markers PINP and β-CTX in blood.Clinica chimica acta; international journal of clinical chemistry · 2021Article
- Correlation between bone turnover and metabolic markers with age and gender: a cross-sectional study of hospital information system data.BMC musculoskeletal disorders · 2020Article
- Fusion Potential of Human Osteoclasts In Vitro Reflects Age, Menopause, and In Vivo Bone Resorption Levels of Their Donors-A Possible Involvement of DC-STAMP.International journal of molecular sciences · 2020Article
- The effect of normalization of sodium on bone turnover markers in patients with epilepsy. A randomized single-blinded placebo-controlled trial.Contemporary clinical trials communications · 2020Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Bone turnover markers are used for monitoring osteoporosis treatment. Therefore, we evaluated the agreement between different assays for CTX and PINP and established reference intervals in a cohort of 2300 individuals. We found poor agreement between assays and different reference intervals. This highlights the importance of harmonization of the assays.
introductionTwo reference markers for bone turnover have been proposed: CTX bone resorption and P1NP for bone formation. The purpose of the current study was to establish reference intervals for the two markers in a Danish cohort and to determine the agreement on the two platforms.
methodsFasting sera from 2308 individuals (1250 males and 1058 females, age range 24-76 years) participating in the Health2006 study were analyzed for CTX and P1NP using the automated IDS-iSYS analyzer and the automated Cobas e411 analyzer. Participants in anti-osteoporotic treatment were excluded, while subjects on hormonal contraceptives were included.
resultsThere was significant disagreement between both the two P1NP assays with a mean difference of -3 μg/L (LoA -19 to 14) (p < 0.001) and the two CTX assays with a mean difference of 13 ng/L (LoA-187 to 214) (p < 0.001). For CTX, there was a systematic bias: at low values, Cobas measured a higher value than iSYS and at higher concentrations, iSYS measured increasingly higher values than Cobas. Based on the results, we propose three reference intervals for each sex: 25-29, 30-39, and 40-80 years for men, and 25-29, >30 (pre-menopausal), and >30 years (post-menopausal) for women.
conclusionsThere is significant disagreement between the IDS-iSYS and Roche Cobas assays for both reference markers. Consequently, the reference intervals for an adult, healthy population are different depending on the analysis method used. Therefore, repeated measurements of patient samples used for monitoring of treatment should be done on the same assay. Moreover, assay-specific reference intervals should be used. Harmonization of assays for BTM is highly warranted.
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