Role of Romosozumab in clinical practice in the light of evidence
PDF (Español (España))
xhtml (Español (España))

Keywords

osteoporosis
romosozumab
sclerostin
denosumab
teriparatide

How to Cite

Román-González, A., Builes-Barrera, C. A. ., & Cons Molina, F. F. . (2022). Role of Romosozumab in clinical practice in the light of evidence. Revista Colombiana De Endocrinología, Diabetes &Amp; Metabolismo, 8(3). https://doi.org/10.53853/encr.8.3.687

Abstract

Osteoporosis is a systemic bone disease characterized by decrease bone quality and quantity predisposing patients to an increased fracture risk. Different drug treatments are available. however, some patients have a very high fracture risk and have fractures despite treatment. For instance, patients with recent fractures, T-score <-3.0, patients using glucocorticoids and people older than 70 years, have a very high risk of osteoporotic fractures. In these cases, osteoanabolic drugs provide the strongest bone protection and must be used frontline. The discovery of mutations in the gene that encodes the sclerostin protein in Van Buchem disease and sclerosteosis allowed the development of the monoclonal antibody against this protein known as romosozumab. This osteoanabolic drug decreases fracture risk and its use is recommended in patients with a very high risk of fractures. The recommended duration for romosozumab is 12 months; however, additional cycles of treatment are possible. This drug provides an opportunity for most difficult cases and for patients with very high-risk. of fractures.

https://doi.org/10.53853/encr.8.3.687
PDF (Español (España))
xhtml (Español (España))

References

Camacho PM, Petak SM, Binkley N, Clarke BL, Harris ST, Hurley DL, et al. American Association Of Clinical Endocrinologists And American College Of Endocrinology Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis - 2016. Endocr Pract. 2016;22(S4):1-42.

Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, Center JR. Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA. 2009;301(5):513-21.

Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997;103(2A):12S-7S; discussion 7S-9S.

Anastasilakis AD, Polyzos SA, Yavropoulou MP, Makras P. Combination and sequential treatment in women with postmenopausal osteoporosis. Expert Opin Pharmacother. 2020;21(4):477-90.

Camacho PM, Petak SM, Binkley N, Diab DL, Eldeiry LS, Farooki A, et al. American Association Of Clinical Endocrinologists/American College Of Endocrinology Clinical Practice Guidelines For The Diagnosis And Treatment Of Postmenopausal Osteoporosis- 2020 Update. Endocr Pract. 2020;26(S1):564-70.

Hamersma H, Gardner J, Beighton P. The natural history of sclerosteosis. Clin Genet. 2003;63(3):192-7.

Maeda K, Kobayashi Y, Koide M, Uehara S, Okamoto M, Ishihara A, et al. The Regulation of Bone Metabolism and Disorders by Wnt Signaling. Int J Mol Sci. 2019;20(22):1-37

Tanaka S. Molecular understanding of pharmacological treatment of osteoporosis. EFORT Open Rev. 2019;4(4):158-64.

Minisola S. Romosozumab: from basic to clinical aspects. Expert Opin Biol Ther. 2014;14(9):1225-8.

Shah AD, Shoback D, Lewiecki EM. Sclerostin inhibition: a novel therapeutic approach in the treatment of osteoporosis. Int J Womens Health. 2015;7:565-80.

Bullock WA, Robling AG. WNT-mediated Modulation of Bone Metabolism: Implications for WNT Targeting to Treat Extraskeletal Disorders. Toxicol Pathol. 2017;45(7):864-8.

Kaplon H, Muralidharan M, Schneider Z, Reichert JM. Antibodies to watch in 2020. MAbs. 2020;12(1):e1703531-24

Blakely KK, Johnson C. New Osteoporosis Treatment Means New Bone Formation. Nurs Womens Health. 2020;24(1):52-7.

Markham A. Romosozumab: First Global Approval. Drugs. 2019;79(4):471-6.

Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016;375(16):1532-43.

Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, et al. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018;33(7):1219-26.

Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017;377(15):1417-27.

Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017;390(10102):1585-94.

Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, et al. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018;103(9):3183-93.

Chouinard L, Felx M, Mellal N, Varela A, Mann P, Jolette J, et al. Carcinogenicity risk assessment of romosozumab: A review of scientific weight-of-evidence and findings in a rat lifetime pharmacology study. Regul Toxicol Pharmacol. 2016;81:212-22.

Khosla S. Bone diseases: Romosozumab - on track or derailed? Nat Rev Endocrinol. 2017;13(12):697-8.

Amgen and UCB announce increased cardiovascular risk in patients receiving romosozumab, an anti-sclerotin antibody. Rheumatology (Oxford). 2017;56(8):e21.

Reid DM. Balancing the risks and benefits of biologic drugs in rheumatic disease: the case for romosozumab? Ther Adv Musculoskelet Dis. 2020;12:1-2

Bovijn J, Krebs K, Chen CY, Boxall R, Censin JC, Ferreira T, et al. Evaluating the cardiovascular safety of sclerostin inhibition using evidence from meta-analysis of clinical trials and human genetics. Sci Transl Med. 2020;12(549):1-21

Lim SY, Bolster MB. Profile of romosozumab and its potential in the management of osteoporosis. Drug Des Devel Ther. 2017;11:1221-31.

Sharifi M, Ereifej L, Lewiecki EM. Sclerostin and skeletal health. Rev Endocr Metab Disord. 2015;16(2):149-56.

Ominsky MS, Boyd SK, Varela A, Jolette J, Felx M, Doyle N, et al. Romosozumab Improves Bone Mass and Strength While Maintaining Bone Quality in Ovariectomized Cynomolgus Monkeys. J Bone Miner Res. 2017;32(4):788-01

Ding LL, Wen F, Wang H, Wang DH, Liu Q, Mo YX, et al. Osteoporosis drugs for prevention of clinical fracture in white postmenopausal women: a network meta-analysis of survival data. Osteoporos Int. 2020. 31(5):961-71

Kendler DL, Bone HG, Massari F, Gielen E, Palacios S, Maddox J, et al. Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab. Osteoporos Int. 2019;30(12):2437-48

McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, et al. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018;33(8):1397-406

Shoback D, Rosen CJ, Black DM, Cheung AM, Murad MH, Eastell R. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update. J Clin Endocrinol Metab. 2020;105(3):587-94

Simpson EL, Martyn-St James M, Hamilton J, Wong R, Gittoes N, Selby P, et al. Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures: A systematic review and network meta-analysis. Bone. 2020;130:1-6

McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014;370(5):412-20

Cosman F, Dempster DW. Anabolic Agents for Postmenopausal Osteoporosis: How Do You Choose? Curr Osteoporos Rep. 2021 19(2):189-205

Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, et al. Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017;32(9):1956-62

Kanis JA, Harvey NC, McCloskey E, Bruyère O, Veronese N, Lorentzon M, et al. Algorithm for the management of patients at low, high and very high risk of osteoporotic fractures. Osteoporos Int. 2020;31(1):1-12.

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Copyright (c) 2021 Revista Endocrino

Downloads

Download data is not yet available.