Reference values of Serum Osteocalcin in the healthy population: A potential biomarker for bone turnover

Authors

  • Tayyaba Rashid Chughtai Institute of Pathology, Lahore Pakistan
  • Muhammad Dilawar Khan Chughtai Institute of Pathology, Lahore Pakistan
  • Hijab Batool Chughtai Institute of Pathology, Lahore Pakistan
  • Masood Afzal Chughtai Institute of Pathology, Lahore Pakistan
  • Muhammad Hashir Nazir King Edward Medical University, Lahore Pakistan
  • Muhammad Ahmad King Edward Medical University, Lahore Pakistan

DOI:

https://doi.org/10.55629/pakjpathol.v35i2.812

Abstract

Objective: To analyze the serum concentrations of osteocalcin in healthy subjects to establish the reference intervals in the Pakistani population.

Material and Methods: This Cross-sectional, observational study was conducted at the Department of Clinical Chemistry and Immunology, Chughtai Lab Lahore from October 2022 to March 2023. Serum samples from 240 healthy subjects (120 males and 120 premenopausal females) were collected according to CLSI recommendations after taking informed consent. The samples were analyzed for the quantitative determination of Osteocalcin by sandwich electrochemiluminescence immunoassay. Shapiro Wilk test was applied to check normality. A P-value of < 0.05 was considered significant. The formulas used for calculating the 2.5th and 97.5th percentiles were 0.025 (n+1) and 0.0975 (n+1) respectively.

Results: The histogram revealed a non-parametric distribution of the data. The established reference intervals by the rank-based method for males were 10.16 ng/mL and 43.33 ng/mL and for females were 5.25 ng/mL and 33.25 ng/mL corresponding to 2.5th and 97.5th percentiles respectively.

Conclusion: Ethnic and geographic variation affects the trends of reference intervals of every parameter. This is the need of the hour each laboratory should establish its assay and population-specific reference intervals for accurate clinical decisions.

Keywords: Osteocalcin, Reference values, Bone density, Osteoporosis

References

Hannemann A, Friedrich N, Spielhagen C, Rettig R, Ittermann T, Nauck M, et al. Reference intervals for serum osteocalcin concentrations in adult men and women from the study of health in Pomerania. BMC Endocr Disord. 2013;13(1);11.

DOI:: https://doi.org/10.1186%2F1472-6823-13-11

Niedźwiedzki T, Filipowska J. Bone remodeling in the context of cellular and systemic regulation: The role of osteocytes and the nervous system. J Mol Endocrinol. 2015; 55(2): 23-36.

DOI: https://doi.org/10.1530/jme-15-0067

Monjardino T, Silva P, Amaro J, Carvalho O, Guimarães JT, Santos AC, et al. Bone formation and resorption markers at 7 years of age: Relations with growth and bone mineralization. PLoS One. 2019; 14(8): e0219423.

DOI:https://doi.org/10.1371%2Fjournal.pone.0219423

Kojima N, Sakata S, Nakamura S, Nagai K, Takuno H, Ogawa T, et al. Serum concentrations of osteocalcin in patients with hyperthyroidism, hypothyroidism and subacute thyroiditis. J Endocrinol Invest. 1992; 15(7): 491-6.

DOI: https://doi.org/10.1007/bf03348786

Lin X, Patil S, Gao YG, Qian A. The bone extracellular matrix in bone formation and regeneration. Front Pharmacol. 2020 May 26; 11: 757. DOI: https://doi.org/10.3389/fphar.2020.00757

Greenblatt MB, Tsai JN, Wein MN. Bone turnover markers in the diagnosis and monitoring of metabolic bone disease. Clin Chem. 2017; 63(2): 464–74.

DOI: https://doi.org/10.1373/clinchem.2016.259085

Li W, Wang Y, Dong J, Di R, Liu X, Liu S. Age- and sex-specific differences in the association of serum osteocalcin and cardiometabolic risk factors in type 2 diabetes. Diabetol Metabo Syndr. 2022; 15: 48.

DOI: https://doi.org/10.1186/s13098-023-01021-0

Iqbal S, Ghani F, Siddiqi I, Khan AH. Verification and determination of the thyroid peroxidase antibody reference interval: Insight into the CLSI guideline. Lab Med. 2013; 44(2): e37-e43.

DOI: https://doi.org/10.1309/lmj2j52mpmfshdgx

Ozarda Y, Higgins V, Adeli K. Verification of reference intervals in routine clinical laboratories: practical challenges and recommendations. Clin Chem Lab Med. 2018; 57(1): 30-37.

DOI: https://doi.org/10.1515/cclm-2018-0059

Abebe M, Melku M, Enawgaw B, Birhan W, Deressa T, Terefe B, et al. Reference intervals of routine clinical chemistry parameters among apparently healthy young adults in Amhara National Regional State, Ethiopia. PLoS One. 2018; 13(8): e0201782. DOI:https://doi.org/10.1371%2Fjournal.pone.0201782

Saeed M, Waheed U, Wazeer A, Saba N. Do we need pakistan-specific reference ranges in laboratory medicine? J Lab Physicians. 2023; 15(2): 324-5.

DOI: https://doi.org/10.1055%2Fs-0042-1760669

Geffré A, Friedrichs K, Harr K, Concordet D, Trumel C, Braun JP. Reference values: A review. Vet Clin Pathol. 2009; 38(3): 288-98.

DOI: https://doi.org/10.1111/j.1939-165x.2009.00 17 9.x

Araújo PA, Thomas D, Sadeghieh T, Bevilacqua V, Chan MK, Chen Y, et al. CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical assays. Clin Biochem. 2015; 48(13-14): 870-80.

DOI: https://doi.org/10.1016/j.clinbiochem.2015.06. 002

Henny J. The IFCC recommendations for determining reference intervals: Strengths and limitations J Lab Med. 2009; 33(2): 45–51.

DOI: https://doi.org/10.1515/JLM.2009.016

Ozarda Y. Reference intervals: Current status, recent developments and future considerations. Biochemia Medica. 2016; 5-16.

DOI: https://doi.org/10.11613/bm.2016.001

Płaczkowska S, Terpińska M, Piwowar A. The importance of establishing reference intervals - is it still a current problem for laboratory and doctors? Clin Lab. 2020; 66.

DOI: https://doi.org/10.7754/clin.lab.2020.191120

Ozarda Y, Higgins V, Adeli K. Verification of reference intervals in routine clinical laboratories: Practical challenges and recommendations. Clin Chem Lab Med. 2018; 57(1): 30–7.

DOI: https://doi.org/10.1515/cclm-2018-0059

Zhou Q, Li X, Jia Y, Guo W, Guan B, Xu J. Establishment and verification of sex- and age-specific serum electrolyte reference intervals in healthy han children in Changchun, Northeastern China. Biomed Res Int. 2019; 2019: 8282910.

Muneer S, Siddiqui I, Majid H, Jafri L, Humayun KN, Ahmed S, et al. Establishing reference interval for thyroid-stimulating hormone in children below two-year ages in Pakistani population. Ann Med Surg. 2021; 68: 102601.

DOI:https://doi.org/10.1016%2Fj.amsu.2021.102601

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Published

01-07-2024

How to Cite

1.
Rashid T, Khan MD, Batool H, Afzal M, Nazir MH, Ahmad M. Reference values of Serum Osteocalcin in the healthy population: A potential biomarker for bone turnover. Pak J Pathol [Internet]. 2024 Jul. 1 [cited 2024 Dec. 22];35(2):76-80. Available from: https://pakjpath.com/index.php/Pak-J-Pathol/article/view/812