The CPH-MBD Cohort

NCT07193056 | Not Yet Recruiting

• 1 other identifier: H-25039131
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persons with chronic kidney disease (CKD) have a 3-fold increased risk of bone fracture and a 10-fold increased risk of cardiovascular disease than the general population. These increased risks are related to the disturbances in the mineral metabolism, and this clinical entity is termed Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD). The overall aim of the present project is to explore factors that may predict or associate with the development of bone and cardiovascular disease in patients with CKD and hopefully provide insight into underlying mechanisms and pathophysiological pathways for future treatment and prevention. In a sub study investigators aim to explore the calcium and phosphate balance in patients with CKD and describe how these associate with each other as well as with kidney function (eGFR).

Conditions

Chronic Kidney Disease Mineral and Bone Disorder; Chronic Kidney Disease (CKD); Bone Markers

Keywords

bone markers; parathyroid hormone; fracture risk; bone turnover; dietary assessment

Outcome Measures

Primary Outcomes (1)

• Difference in time to first fracture between patients with normal bone turnover and low bone turnover based on bone turnover markers at baseline

  25 years

Secondary Outcomes (7)

• Time to fracture

  25 years

• Time to cardiovascular event

  25 years

• Progression in kidney disease

  25 years

• Time to end-stage kidney disease

  25 years

• Time to death

  25 years

Study Arms (2)

CPH-MBD cohort

Participants will be followed-up for 25 years after inclusion. Bone fractures, cardiovascular events, progression of kidney disease, end-stage kidney disease and death will be collected through linkage with registries during follow-up. There is no intervention in this study.

Detailed dietary assessment

From the CPH-MBD cohort we invite 50 participants to complete a dietary assessment to obtain more accurate information about their calcium and phosphate intake.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the outpatient clinic, Department of Nephrology at Herlev Hospital. The outpatient clinic has approximately 1500 patients with CKD4-5nonD.

You may qualify if:

• Age ≥18 years
• CKD stage 4-5nonD (eGFR ≤ 29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition

You may not qualify if:

• None

Sponsors & Collaborators

• Herlev Hospital: lead

Related Publications (21)

• Naylor KL, McArthur E, Leslie WD, Fraser LA, Jamal SA, Cadarette SM, Pouget JG, Lok CE, Hodsman AB, Adachi JD, Garg AX. The three-year incidence of fracture in chronic kidney disease. Kidney Int. 2014 Oct;86(4):810-8. doi: 10.1038/ki.2013.547. Epub 2014 Jan 15.

  PMID: 24429401 BACKGROUND

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

  PMID: 23732715 BACKGROUND

• Svendsen SL, Rousing AQ, Carlsen RK, Khatir D, Jensen D, Hansen NM, Salomo L, Birn H, Buus NH, Leipziger J, Sorensen MV, Berg P. A Urine pH-Ammonium Acid/Base Score and CKD Progression. J Am Soc Nephrol. 2024 Nov 1;35(11):1533-1545. doi: 10.1681/ASN.0000000000000447. Epub 2024 Jul 17.

  PMID: 39485702 BACKGROUND

• Evenepoel P, Jorgensen HS, Bover J, Davenport A, Bacchetta J, Haarhaus M, Hansen D, Gracia-Iguacel C, Ketteler M, McAlister L, White E, Mazzaferro S, Vervloet M, Shroff R. Recommended calcium intake in adults and children with chronic kidney disease-a European consensus statement. Nephrol Dial Transplant. 2024 Jan 31;39(2):341-366. doi: 10.1093/ndt/gfad185.

  PMID: 37697718 BACKGROUND

• Moretti A, Iolascon G. Sclerostin: clinical insights in muscle-bone crosstalk. J Int Med Res. 2023 Aug;51(8):3000605231193293. doi: 10.1177/03000605231193293.

  PMID: 37632438 BACKGROUND

• Li G, Zhang L, Wang D, AIQudsy L, Jiang JX, Xu H, Shang P. Muscle-bone crosstalk and potential therapies for sarco-osteoporosis. J Cell Biochem. 2019 Sep;120(9):14262-14273. doi: 10.1002/jcb.28946. Epub 2019 May 20.

  PMID: 31106446 BACKGROUND

• Iwasaki Y, Kazama JJ, Fukagawa M. Molecular Abnormalities Underlying Bone Fragility in Chronic Kidney Disease. Biomed Res Int. 2017;2017:3485785. doi: 10.1155/2017/3485785. Epub 2017 Mar 22.

  PMID: 28421193 BACKGROUND

• Rashid A, Chaudhary Hauge S, Suetta C, Hansen D. "Sarcopenia and risk of osteoporosis, falls and bone fractures in patients with chronic kidney disease: A systematic review". PLoS One. 2022 Jan 21;17(1):e0262572. doi: 10.1371/journal.pone.0262572. eCollection 2022.

  PMID: 35061818 BACKGROUND

• Lai S, Muscaritoli M, Andreozzi P, Sgreccia A, De Leo S, Mazzaferro S, Mitterhofer AP, Pasquali M, Protopapa P, Spagnoli A, Amabile MI, Molfino A. Sarcopenia and cardiovascular risk indices in patients with chronic kidney disease on conservative and replacement therapy. Nutrition. 2019 Jun;62:108-114. doi: 10.1016/j.nut.2018.12.005. Epub 2018 Dec 11.

  PMID: 30875540 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

  PMID: 31081853 BACKGROUND

• Mace ML, Egstrand S, Morevati M, Olgaard K, Lewin E. New Insights to the Crosstalk between Vascular and Bone Tissue in Chronic Kidney Disease-Mineral and Bone Disorder. Metabolites. 2021 Dec 7;11(12):849. doi: 10.3390/metabo11120849.

  PMID: 34940607 BACKGROUND

• Mace ML, Gravesen E, Nordholm A, Egstrand S, Morevati M, Olgaard K, Lewin E. The Calcified Vasculature in Chronic Kidney Disease Secretes Factors that Inhibit Bone Mineralization. JBMR Plus. 2022 Mar 1;6(4):e10610. doi: 10.1002/jbm4.10610. eCollection 2022 Apr.

  PMID: 35434452 BACKGROUND

• Barreto DV, Barreto Fde C, Carvalho AB, Cuppari L, Draibe SA, Dalboni MA, Moyses RM, Neves KR, Jorgetti V, Miname M, Santos RD, Canziani ME. Association of changes in bone remodeling and coronary calcification in hemodialysis patients: a prospective study. Am J Kidney Dis. 2008 Dec;52(6):1139-50. doi: 10.1053/j.ajkd.2008.06.024. Epub 2008 Sep 27.

  PMID: 18824289 BACKGROUND

• Jorgensen HS, Behets G, Viaene L, Bammens B, Claes K, Meijers B, Naesens M, Sprangers B, Kuypers D, Cavalier E, D'Haese P, Evenepoel P. Diagnostic Accuracy of Noninvasive Bone Turnover Markers in Renal Osteodystrophy. Am J Kidney Dis. 2022 May;79(5):667-676.e1. doi: 10.1053/j.ajkd.2021.07.027. Epub 2021 Oct 26.

  PMID: 34710517 BACKGROUND

• Salam S, Gallagher O, Gossiel F, Paggiosi M, Khwaja A, Eastell R. Diagnostic Accuracy of Biomarkers and Imaging for Bone Turnover in Renal Osteodystrophy. J Am Soc Nephrol. 2018 May;29(5):1557-1565. doi: 10.1681/ASN.2017050584. Epub 2018 Mar 19.

  PMID: 29555831 BACKGROUND

• Haarhaus M, Evenepoel P; European Renal Osteodystrophy (EUROD) workgroup; Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) working group of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA). Differentiating the causes of adynamic bone in advanced chronic kidney disease informs osteoporosis treatment. Kidney Int. 2021 Sep;100(3):546-558. doi: 10.1016/j.kint.2021.04.043. Epub 2021 Jun 5.

  PMID: 34102219 BACKGROUND

• Moe S, Drueke T, Cunningham J, Goodman W, Martin K, Olgaard K, Ott S, Sprague S, Lameire N, Eknoyan G; Kidney Disease: Improving Global Outcomes (KDIGO). Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2006 Jun;69(11):1945-53. doi: 10.1038/sj.ki.5000414.

  PMID: 16641930 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.

  PMID: 30675420 BACKGROUND

• Vestergaard SV, Christiansen CF, Thomsen RW, Birn H, Heide-Jorgensen U. Identification of Patients with CKD in Medical Databases: A Comparison of Different Algorithms. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):543-551. doi: 10.2215/CJN.15691020. Epub 2021 Mar 11.

  PMID: 33707181 BACKGROUND

• Xie Y, Bowe B, Mokdad AH, Xian H, Yan Y, Li T, Maddukuri G, Tsai CY, Floyd T, Al-Aly Z. Analysis of the Global Burden of Disease study highlights the global, regional, and national trends of chronic kidney disease epidemiology from 1990 to 2016. Kidney Int. 2018 Sep;94(3):567-581. doi: 10.1016/j.kint.2018.04.011. Epub 2018 Aug 3.

  PMID: 30078514 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.

  PMID: 19644521 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, plasma and serum

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency

Study Officials

• Ditte Hansen, Medical doctor, professor

  Department of Nephrology, Herlev Hospital

  STUDY DIRECTOR

Central Study Contacts

Freja S Hassager, Medical doctor

CONTACT

+4522554707; freja.staehr.hassager.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2055
• Study Completion (Estimated): January 1, 2055
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share