World Osteoporosis Day (20th October)
Eminent Author, Medical Biochemist and Scientist, Technical Education consultant.
AGD Biomedicals (Pvt) LTD. Andheri East, Mumbai.
Detection and prevention of rapid progression of osteoporosis by early detection, using IVD laboratory tests (1,2), along with X-ray absorptiometry (DXA)(3) and physical examination, is the main purpose of “World Osteoporosis Day 2024”. With a worldwide aging population, and considering the fact that India has very high population of elderly persons among 1.45 billion population, the prevention and management of osteoporosis has become a significant healthcare challenge(4). Various studies have revealed an osteoporosis prevalence in Indian women ranging from 8% to 62%(5). Advanced age, poor intake of dietary calcium and vitamin D, hormonal changes (low testosterone in male and low estrogens in female), genetic and epigenetic factors, socioeconomical factors and lifestyle changes contribute to osteoporosis(6). With significant paucity of DXA test facilities mainly in the rural areas, IVD routine blood and urine tests could be extremely useful for the early detection of osteoporosis (7).
Q1. What specific routine IVD Clinical laboratory tests commonly used for the detection of osteoporosis?
ANS: Osteoporosis is often diagnosed using the following routine laboratory tests (13,14):
| OSTEOPOROSIS ROUTINE TESTS | EXPECTED VALUES |
| 1) Serum calcium | Low |
| 2) Serum inorganic phosphorus | Low |
| 3) Serum alkaline phosphorus | High |
| 4) Serum parathyroid hormone | High |
| 5) Serum calcitonin | Low |
| 6) Serum Vitamin D | Low |
| 7) Serum magnesium | Low |
| 8) Serum zinc | Low |
Q2. What additional laboratory tests are required to diagnose secondary clinical conditions that may lead to progression of osteoporosis?
ANS: ADDITIONAL TESTS: These tests(13,14) indicate underlying secondary disease that may accelerate process of Osteoporosis(7) :
| CLINICAL LABORATORY TEST | OSTEOPOROSIS PRECIPITATING SECONDARY DISEASES |
| 1) Complete hemogram (CBC) | Anemia (Iron-deficiency, megaloblastic, Hemolytic), leukemia, etc |
| 2) Blood glucose (F) and (PP) | Diabetes mellitus (Uncontrolled) |
| 3) T3 and T4 | Hyperthyroidism (Uncontrolled) |
| 4) RA test | Rheumatoid arthritis |
Note
1) Deficiency of iron and other micronutrients accelerate process of osteoporosis.
2) Growth of Cancer cells and related therapies may lead to progression of osteoporosis.
3) Uncontrolled diabetes leads to peripheral neuropathy, leading to progression of osteoporosis.
4) Significant increase in thyroid hormones lead to bone dissolution process.
(5) Specific antibodies targeting bone cartilages lead to osteoporosis progression.
Q3. What are the recent innovations in IVD blood tests that may significantly impact the management and monitoring of Osteoporosis?
| RECENT INNOVATIVE BIOMARKERS (8, 9, 10, 11, 12) | TEST RESULTS |
| 1) Serum and Urine Osteocalcin (a type of protein in bone) | Increase |
| 2) Serum and Urine Procollagen type-1 | Increase |
| 3) Bone-specific serum alkaline phosphatase | Increase |
| 4) Serum and Urine C-telopeptide cross-linked collagen (CTx) | Increase |
| 5) Serum and Urine N-terminal bone peptide (NTx) | Increase |
| 6) C-reactive protein and Serum albumin ratio | Increase |
Note
(1) Tests 1-6 indicate significant increase in bone collagen degradation, leading to bone dissolution and the accelerated process of osteoporosis.
(2) Inflammation in the body contributes to the development of metabolic bone diseases. The C-reactive protein-to-albumin ratio (CAR) is an inflammation-based marker with a prognostic value for several metabolic diseases, including osteoporosis.
Q4. How does timely detection of Osteoporosis by IVD tests impact patient outcomes and overall healthcare costs?
ANS: Osteoporotic fractures can be debilitating and sometimes fatal, among older adults. Osteoporosis fragility fractures pose a substantial economic burden to the healthcare systems in India and other countries in the world. In India osteoporosis fragility fractures are expected to continue to increase with an increasing high aging population.The cost of osteoporosis and related fractures are expected to increase to more than $25 billion by the year 2025(14).Implementation of improved fracture preventive strategies based on latest Clinical IVD tests and markers could prevent overall treatment costs.
References
(1) Osteoporosis:Assessing the risk of fragility fracture. National Institute for Health and Care Excellence (NICE); London: Feb, 2017.
(2) Kanis JA, Delmas P, Burckhardt P, Cooper C, Torgerson D. Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporosis Int. 1997;7(4):390–406.
(3) Koch V, Hokamp NG, Albrecht MH, Gruenewald LD, Yel I, Borggrefe J, Wesarg S, Eichler K, Burck I, Gruber-Rouh T, Lenga L, Vogl TJ, Martin SS, Wichmann JL, Hammerstingl RM, Alizadeh LS, Mader C, Huizinga NA, D’Angelo T, Ascenti G, Mazziotti S, Booz C. Accuracy and precision of volumetric bone mineral density assessment using dual-source dual-energy versus quantitative CT: A phantom study. Eur Radiol Exp. 2021 Oct 05;5(1):43.
(4) National Institute for Health and Care Excellence (NICE). Bone Health Programme: A Proactive Population Approach to Bone Health (October 2017). Available from: https://www.nice.org.uk/sharedlearning/bone-health-programme-proactive-population-approach-to-bone-health. Accessed on 12-June-2020.
(5) Anuradha V Khadilkar and Rubina M Mandlik. Epidemiology and treatment of osteoporosis in women: An Indian perspective. Int J Womens Health. 2015; 7: 841–850.
(6) Askari, M., Lotfi, M. H., Owlia, M. B., Fallahzadeh, H. & Mohammadi, M. Survey of Osteoporosis Risk Factors (Review Article). J. Sabzevar Univ. Med. Sci. 25, 854–863 (2019).
(7) Tannenbaum C, Clark J, Schwartzman K, Wallenstein S, Lapinski R, Meier D, Luckey M. Yield of laboratory testing to identify secondary contributors to osteoporosis in otherwise healthy women. J Clin Endocrinol Metab (2002);87(10):4431-7.
(8) Yan Yan Li, Bo Lin, Xin Li. High C-reactive protein-to-albumin ratio levels are associated with osteoporosis in patients with primary biliary cholangitis. Front Endocrinol, Volume 15, (2024).
(9) Biochemical Markers of Bone Turnover Part I: Biochemistry and Variability. Clin Biochem Rev. 2005 Nov;26(4):97–122.
(10) Lapière CM, Lenaers A, Kohn LD (December 1971). “Procollagen peptidase: an enzyme excising the coordination peptides of procollagen”. Proceedings of the National Academy of Sciences of the United States of America. 68 (12): 3054–8.
(11) Marx, RE; et al. (2007). “Oral Bisphosphonate-Induced Osteonecrosis: Risk Factors, Prediction of Risk Using Serum CTX Testing, Prevention, and Treatment”. J Oral Maxillofac Surg. 65 (12): 2397–2410.
(12) Iba, Kousuke; Takada, Junichi; Hatakeyama, Naoko; Ozasa, Yasuhiro; Wada, Takuro; Yamashita, Toshihiko (2008). “Changes in urinary NTX levels in patients with primary osteoporosis undergoing long-term bisphosphonate treatment”. Journal of Orthopaedic Science. 13 (5): 438–441.
(13) Godkar PB, Godkar DP. Medical Biochemistry, Theory and Practicals (1st edition, 2024), CBS Publishers, New Delhi, India.
(14) A Singer, M R McClung, O Tran, C D Morrow, S Goldstein, R Kagan, M McDermott, A Yehoshua. Treatment rates and healthcare costs of patients with fragility fracture by site of care: a real-world data analysis. Arch Osteoporos (2023) Mar 11;18(1):42.
