Modern prescribing practices and perspectives among Indian Orthopaedicians on Denosumab in osteoporosis: a cross-sectional survey
DOI:
https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20253422Keywords:
Bone mineral density, Bisphosphonates, Denosumab, Fracture risk, Osteoporosis, Postmenopausal osteoporosisAbstract
Background: Denosumab reduces vertebral, hip and nonvertebral fracture risk by improving bone mineral density (BMD) in Osteoporosis. This survey aimed to understand the prescribing patterns and perspectives of Denosumab Indian Orthopaedic practice.
Methods: This cross-sectional survey was conducted among Indian Orthopaedicians for insights on Denosumab prescription patterns, patient profile, treatment duration, adherence, safety and efficacy. Data were analysed descriptively by cross-tabulation.
Results: Among 91 Orthopaedicians prescribing Denosumab for Osteoporosis (T-score<-2.5), 63.74% prescribed for fragility fractures, 60.44% to prevent recurrent fractures and 57.14% in patients without fragility fractures. Denosumab was preferred considering better patient compliance (56.04%), safety (54.95%), efficacy (51.65%) and dosing frequency (49.45%). Patient adherence for up to three years was reported by 79.13%. Teriparatide was the most common drug prescribed in combination (55%) or sequential manner (60% pre and 30.43% post-denosumab). Calcium and Vitamin D were supplemented by 94.51% of doctors. Denosumab drug holiday was not recommended by 62.64%. Approximately 52.7% and 66.7% of doctors reported 10% and 20% BMD increases after 12 and 12-24 months of therapy, respectively. Highest improvements were reported in the lumbar spine and hip. Myalgia (60.44%) and musculoskeletal pain (26.37%) were the most common side effects. Among all, 82.4% prescribed Denosumab in elderly osteoporotic patients with co-morbidities like diabetes (85.33%), cardiovascular disorders (62.67%), renal (54.67%) and hepatic impairment (21.33%).
Conclusions: Our findings underscore the significance of Denosumab in Osteoporosis with insights into the prescribing patterns of Indian Orthopaedicians. It highlights the need for strategies to improve patient adherence for optimizing therapeutic outcomes.
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References
Chandran M, Brind’Amour K, Fujiwara S. Prevalence of osteoporosis and incidence of related fractures in developed economies in the Asia Pacific region: a systematic review. Osteoporos Int. 2023;34(6):1037-53. DOI: https://doi.org/10.1007/s00198-022-06657-8
Bhadada SK, Chadha M, Sriram U. The Indian Society for Bone and Mineral Research (ISBMR) position statement for the diagnosis and treatment of osteoporosis in adults. Arch Osteoporos. 2021;16(1):102. DOI: https://doi.org/10.1007/s11657-021-00954-1
Salari N, Ghasemi H, Mohammadi L. The global prevalence of osteoporosis in the world: a comprehensive systematic review and meta-analysis. J Orthop Surg Res. 2021;16(1):609. DOI: https://doi.org/10.1186/s13018-021-02772-0
de Villiers TJ, Goldstein SR: Bone Health 2022: an update. Climacteric. 2022;25(1):1-3. DOI: https://doi.org/10.1080/13697137.2021.1965408
Babhulkar S, Seth S: Prevalence of osteoporosis in India: an observation of 31238 adults. Int J Res Orthop. 2021;7(2):362-8. DOI: https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20210630
Nallasivan S: Current treatment of osteoporosis. Indian J Rheumatol. 2019;14(1):57-60. DOI: https://doi.org/10.4103/injr.injr_74_18
Compston JE, McClung MR, Leslie WD: Osteoporosis. Lancet. 2019;393(10169):364-76. DOI: https://doi.org/10.1016/S0140-6736(18)32112-3
Aibar-Almazán A, Voltes-Martínez A, Castellote-Caballero Y, Afanador-Restrepo DF, Carcelén-Fraile MDC, López-Ruiz E. Current status of the diagnosis and management of osteoporosis. Int J Mol Sci. 2022;23(16):9465. DOI: https://doi.org/10.3390/ijms23169465
Diab DL, Watts NB: Denosumab in osteoporosis. Expert Opin Drug Saf. 2014;13(2):247-53. DOI: https://doi.org/10.1517/14740338.2014.860133
Cummings SR, San Martin J, McClung MR. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361:756-65. DOI: https://doi.org/10.1056/NEJMoa0809493
Bone HG, Wagman RB, Brandi ML. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017;5:513-23. DOI: https://doi.org/10.1016/S2213-8587(17)30138-9
Naik-Panvelkar P, Norman S, Elgebaly Z. Osteoporosis management in Australian general practice: an analysis of current osteoporosis treatment patterns and gaps in practice. BMC Fam Pract. 2020;21(1):32. DOI: https://doi.org/10.1186/s12875-020-01103-2
Noble JA, McKenna MJ, Crowley RK: Should denosumab treatment for osteoporosis be continued indefinitely. Ther Adv Endocrinol Metab. 2021;12:20420188211010052. DOI: https://doi.org/10.1177/20420188211010052
Erra A, Grados DA: B0883 Denosumab: patterns of prescription and side effects in 68 patients. Ann Rhuem Dis. 2015;74:1196. DOI: https://doi.org/10.1136/annrheumdis-2015-eular.5893
Lai EC, Lin TC, Lange JL. Effectiveness of denosumab for fracture prevention in real-world postmenopausal women with osteoporosis: a retrospective cohort study. Osteoporos Int. 2022;33(5):1155-64. DOI: https://doi.org/10.1007/s00198-021-06291-w
Delsmann MM, Schmidt C, Mühlenfeld M. Prevalence of osteoporosis and osteopenia in elderly patients scheduled for total knee arthroplasty. Arch Orthop Trauma Surg. 2021;2:1-8. DOI: https://doi.org/10.1007/s00402-021-04297-x
Murahashi Y, Teramoto A, Jimbo S. Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplasty. Knee. 2020;27(2):580-6. DOI: https://doi.org/10.1016/j.knee.2019.12.010
Tani S, Ishikawa K, Kudo Y. The effect of denosumab on pedicle screw fixation: a prospective 2-year longitudinal study using finite element analysis. J Orthop Surg Res. 2021;16(1):219. DOI: https://doi.org/10.1186/s13018-021-02360-2
Freemantle N, Satram-Hoang S, Tang ET. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012;23(1):317-26. DOI: https://doi.org/10.1007/s00198-011-1780-1
Briot K, Schott AM, Sanchez JP, Chauny JV, Samama P, Désaméricq G. High persistence over two years with denosumab among postmenopausal women with osteoporosis in France: A prospective cohort study. Bone. 2021;146:115890. DOI: https://doi.org/10.1016/j.bone.2021.115890
Pedersen AB, Risbo N, Kafatos G, Neasham D, O'Kelly J, Ehrenstein V. Utilization patterns and factors associated with persistence of new users of anti-osteoporosis treatment in Denmark: a population-based cohort study. Arch Osteoporos. 2023;18(1):19. DOI: https://doi.org/10.1007/s11657-023-01210-4
McGowan B, Bennett K, Casey MC, Doherty J, Silke C, Whelan B. Comparison of prescribing and adherence patterns of anti-osteoporotic medications post-admission for fragility type fracture in an urban teaching hospital and a rural teaching hospital in Ireland between 2005 and 2008. Ir J Med Sci. 2013;182(4):601-8. DOI: https://doi.org/10.1007/s11845-013-0935-9
Leder BZ, Tsai JN, Uihlein AV. Two years of denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014;99(5):1694-700. DOI: https://doi.org/10.1210/jc.2013-4440
Leder BZ, Tsai JN, Uihlein AV. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA‐Switch study): extension of a randomised controlled trial. Lancet. 2015;386(99):1147–55. DOI: https://doi.org/10.1016/S0140-6736(15)61120-5
Tay WL, Tay D. Discontinuing denosumab: can it be done safely? a review of the literature. Endocrinol Metab (Seoul). 2022;37(2):183-94. DOI: https://doi.org/10.3803/EnM.2021.1369
Gregson CL, Armstrong DJ, Bowden J. UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos. 2022;17(1):58. DOI: https://doi.org/10.1007/s11657-022-01061-5
Suzuki T, Nakamura Y, Kato H. Calcium and vitamin D supplementation with 3-year denosumab treatment is beneficial to enhance bone mineral density in postmenopausal patients with osteoporosis and rheumatoid arthritis. Ther Clin Risk Manag. 2018;15:15-22. DOI: https://doi.org/10.2147/TCRM.S182858
Hayashi S, Fukuda K, Maeda T. Denosumab treatment improved health-related quality of life in osteoporosis: a prospective cohort study. JBMR Plus. 2019;3(7):10191. DOI: https://doi.org/10.1002/jbm4.10191
Bird ST, Smith ER, Gelperin K. Severe hypocalcemia with denosumab among older female dialysis-dependent patients. JAMA. 2024;331(6):491-9. DOI: https://doi.org/10.1001/jama.2023.28239