PURPOSE: The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have proposed procollagen type I N propeptide (PINP) and β isomerized C-terminal telopeptide of type I collagen (β-CTX-I) as reference bone turnover markers (BTMs) for osteoporosis. This report examines the published literature since the 2011 IOF-IFCC position paper in order to determine the clinical potential of the reference BTMs and newer markers for the prediction of fracture risk and monitoring the treatment of osteoporosis. METHODS: Evidence for the relationship between BTMs and subsequent fractures was gathered from prospective studies through literature review of the Medline database from years 2011 to May 2024. The impact of treatment on BTMs was also studied by examining publications in that period. Studies of the accuracy of BTMs in the assessment of bone turnover in the setting of advanced chronic kidney disease were also examined. RESULTS: Increased BTM concentrations are associated with higher fracture risk in postmenopausal women. PINP and β-CTX-I measured in blood are associated with fracture risk but their interaction with other risk factors has not been sufficiently studied limiting their incorporation into fracture risk algorithms. Treatment-induced changes in PINP and β-CTX-I account for a substantial proportion of fracture risk reduction and are useful for improving adherence; they are recommended for inclusion in studies to examine adherence in individual patients. However, total PINP (tPINP) and β-CTX-I may be elevated in CKD due to renal retention. Bone alkaline phosphatase (BALP), intact PINP (iPINP), and tartrate resistant acid phosphatase 5b (TRACP5b) show the most promise in discriminating high and low turnover bone diseases in patients with advanced CKD and for predicting fracture risk, monitoring treatment response, and assessing the risk of treatment-related complications. CONCLUSION: We re-affirm the use of serum/plasma tPINP and plasma β-CTX-I as reference BTMs with appropriate patient preparation and sample handling and measurement by standardized/harmonized assays in clinical studies to accumulate further data, and for monitoring treatment of osteoporosis in the setting of normal renal function in clinical practice. BALP and TRACP5b, measured by standardized assays, are recommended as reference BTMs for CKD-associated osteoporosis and should be included in observational and intervention studies to ascertain their utility for risk-evaluation, treatment initiation, and assessment of treatment response in CKD-associated osteoporosis.

Biochemistry Department College of Science King Saud University Riyadh 11451 Kingdom of Saudi Arabia

Cedars Sinai Medical Center OMC Clinical Research Center Beverly Hills CA 90211 USA

Centre for Metabolic Bone Diseases University of Sheffield Sheffield UK

Centro de Estudos Egas Moniz Faculdade de Medicina da Universidade de Lisboa Av Prof Egas Moniz 1649 028 Lisbon Portugal

CHU de Liège and Centre de Recherche Intégré Sur Les Médicaments Department of Clinical Chemistry University of Liège Domaine du Sart Tilman B 4000 Liège Belgium

CHU de Liège and Centre de Recherche Intégré Sur Les Médicaments Department of Clinical Pharmacology University of Liège Domaine du Sart Tilman B 4000 Liège Belgium

Clinical Biochemistry Department General Hospital of Lamia 35100 Lamia Greece

Clinical Biochemistry Department KAT General Hospital Kifissia Athens Greece

Clinical Epidemiology Unit Faculty of Medicina UNAM Hospital Infantil Federico Gómez Mexico City Mexico

Clinical Institute of Medical and Chemical Diagnostics Medical University of Graz Auenbruggerplatz 15 1 8036 Graz Austria

Department of Athletics Strength and Conditioning Poznań University of Physical Education Poznań Poland

Department of Clinical Biochemistry and Bone Metabolism Klatovska Hospital Klatovy Czech Republic

Department of Clinical Biochemistry and Haematology Faculty of Medicine Pilsen Charles University Prague Pilsen Czech Republic

Department of Clinical Biochemistry Rigshospitalet Copenhagen Denmark

Department of Clinical Medicine and Department of Nephrology Aalborg University Hospital Aalborg Denmark

Department of Clinical Medicine Department of Medicine and Nephrology Aarhus University Aarhus Denmark

Department of Clinical Medicine Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Department of Endocrinology Ghent University Hospital Ghent Belgium

Department of Health Services Research CAPHRI Care and Public Health Research Institute Maastricht University Maastricht Netherlands

Department of Immunology and Transplantation Nephrology and Renal Transplantation Research Group KatholiekeUniversitet Leuven Louvain Belgium

Department of Laboratory Medicine Faculty of Medicine University of Debrecen Nagyerdei Blvd 98 4032 Debrecen Hungary

Department of Physical Medicine and Rehabilitation Cerrahpaşa School of Medicine Istanbul University Cerrahpaşa Istanbul Turkey

Diaverum AB Hyllie Boulevard 53 215 37 Malmö Sweden

Division d'Epidémiologie Santé Publique Et Economie de La Santé Université de Liège Liège Belgium

Division of Clinical Medicine School of Medicine and Population Health University of Sheffield Sheffield UK

Division of Renal Medicine Department of Clinical Science Intervention and Technology Karolinska Institutet Karolinska University Hospital 141 86 Stockholm Sweden

Faculdade de Farmácia Universidade de Lisboa Avenida Professor Gama Pinto 1649 003 Lisbon Portugal

Faculty of Health Care Studies University of West Bohemia Pilsen Czech Republic

Faculty of Medicine University of Novi Sad Novi Sad Serbia

Faculty of Pharmaceutical Sciences Hokuriku University Kanazawa Japan

Geneva University Hospitals Faculty of Medicine Geneva Switzerland

Icelandic Medicines Agency Vínlandsleið 14 113 Reykjavík Iceland

INSERM UMR 1033 Université Claude Bernard Lyon1 Hôpital E Herriot 69437 Lyon France

Institute of Clinical Physiology 56124 Pisa and Department of Medicine National Research Council University of Padova Padua Italy

Laboratory for Research of the Musculoskeletal System Th Garofalidis Medical School University of Athens Athens Greece

Laboratory of Experimental Biochemistry IRCCS Ospedale Galeazzi Sant'Ambrogio Milan Italy

Laboratory of Systems Integration Pharmacology Clinical and Regulatory Science Research Institute for Medicines of the University of Lisbon Lisbon Portugal

MRC Lifecourse Epidemiology Centre University of Southampton Southampton UK

NIHR Southampton Biomedical Research Centre University of Southampton and University Hospital Southampton NHS Foundation Trust Southampton UK

PathWest Laboratory Medicine WA Murdoch WA6150 Australia

Scientific Office Austrian Medicines and Medical Devices Agency Vienna Austria

Spanish Agency for Medicines and Medical Devices Madrid Spain

Translational Research Centre Rigshospitalet Copenhagen Denmark

University Hospitals Leuven and Laboratory of Nephrology Department of Microbiology Immunology and Transplantation KU Leuven Louvain Belgium

University of Tunis El Manar Tunis Tunisia

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