Early Clinical Effects, Safety, and Predictors of the Effects of Romosozumab Treatment in Osteoporosis Patients: One-year Study

Overview

Journal Osteoporos Int

Specialties Endocrinology
Orthopedics

Date 2021 Mar 26

PMID 33770201

Citations 12

Authors

A Tominaga

K Wada

K Okazaki

H Nishi

Y Terayama

Y Kato

Affiliations

Soon will be listed here.

Abstract

Introduction: Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody, which increases bone formation and suppresses bone resorption. The aim of our study was to elucidate the clinical effects, safety, and predictors of the effects of one-year romosozumab treatment.

Methods: This study was an observational study designed as a pre-post study in 262 patients. Romosozumab (210 mg) was administered subcutaneously once every 4 weeks during 12 months. We focused on incidence of new fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers.

Results: There were five cases of new fractures during one-year romosozumab treatment. There were no fatal adverse events. Percent changes from baseline in the spine and total hip BMD after 12 months of romosozumab treatment were 10.67% and 2.04%, respectively. Romosozumab had better effects in cases of severe osteoporosis with low spine BMD, high TRACP-5b, and high iP1NP at the start of romosozumab treatment. The percent change in the spine BMD at 12 months was significantly lower in the group transitioning from bisphosphonates than in the group not previously treated with other anti-osteoporosis medications.

Conclusion: Romosozumab is an effective treatment for spine osteoporosis because it significantly increases the percent change in the spine BMD at 12 months. The percent change in the spine BMD is higher in patients not previously treated with other anti-osteoporosis medications.

Citing Articles

Sequential and combination therapy with romosozumab.

Kobayakawa T J Bone Miner Metab. 2025; .

PMID: 40024934 DOI: 10.1007/s00774-025-01590-2.

Romosozumab adverse event profile: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) from 2019 to 2023.

Liu L, Wu S, Wei L, Xia Z, Ji J, Huang D Aging Clin Exp Res. 2025; 37(1):23.

PMID: 39808360 PMC: 11732777. DOI: 10.1007/s40520-024-02921-5.

Sclerostin and Cardiovascular Risk: Evaluating the Cardiovascular Safety of Romosozumab in Osteoporosis Treatment.

Chiu S, Wu W, Yao T, Peng C, Yeh K Biomedicines. 2025; 12(12.

PMID: 39767786 PMC: 11673789. DOI: 10.3390/biomedicines12122880.

Therapy with transitions from one bone-forming agent to another: a retrospective cohort study on teriparatide and romosozumab.

Kobayakawa T, Kanayama Y, Hirano Y, Yukishima T, Nakamura Y JBMR Plus. 2024; 8(12):ziae131.

PMID: 39605880 PMC: 11601723. DOI: 10.1093/jbmrpl/ziae131.

Romosozumab for the treatment of osteoporosis - a systematic review.

Makinen V, Solling A, McClung M, Langdahl B J Endocrinol Invest. 2024; 48(3):547-572.

PMID: 39487940 DOI: 10.1007/s40618-024-02469-1.

References

Cosman F, Crittenden D, Adachi J, Binkley N, Czerwinski E, Ferrari S . Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016; 375(16):1532-1543. DOI: 10.1056/NEJMoa1607948. View

Yoshimura N, Muraki S, Oka H, Mabuchi A, En-yo Y, Yoshida M . Prevalence of knee osteoarthritis, lumbar spondylosis, and osteoporosis in Japanese men and women: the research on osteoarthritis/osteoporosis against disability study. J Bone Miner Metab. 2009; 27(5):620-8. DOI: 10.1007/s00774-009-0080-8. View

Gertz B, Clemens J, Holland S, Yuan W, Greenspan S . Application of a new serum assay for type I collagen cross-linked N-telopeptides: assessment of diurnal changes in bone turnover with and without alendronate treatment. Calcif Tissue Int. 1998; 63(2):102-6. DOI: 10.1007/s002239900497. View

Langdahl B, Libanati C, Crittenden D, Bolognese M, Brown J, Daizadeh N . 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):1585-1594. DOI: 10.1016/S0140-6736(17)31613-6. View

Yoshimura N, Muraki S, Oka H, Kawaguchi H, Nakamura K, Akune T . Cohort profile: research on Osteoarthritis/Osteoporosis Against Disability study. Int J Epidemiol. 2009; 39(4):988-95. DOI: 10.1093/ije/dyp276. View

Eastell R, Krege J, Chen P, Glass E, Reginster J . Development of an algorithm for using PINP to monitor treatment of patients with teriparatide. Curr Med Res Opin. 2006; 22(1):61-6. DOI: 10.1185/030079905X75096. View

Baron R, Rawadi G . Targeting the Wnt/beta-catenin pathway to regulate bone formation in the adult skeleton. Endocrinology. 2007; 148(6):2635-43. DOI: 10.1210/en.2007-0270. View

Naranjo C, Busto U, Sellers E, Sandor P, Ruiz I, Roberts E . A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981; 30(2):239-45. DOI: 10.1038/clpt.1981.154. View

Igarashi Y, Lee M, Matsuzaki S . Acid phosphatases as markers of bone metabolism. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 781(1-2):345-58. DOI: 10.1016/s1570-0232(02)00431-2. View

10.

Tominaga A, Wada K, Kato Y, Nishi H, Terayama Y, Okazaki K . Early clinical effects, safety, and appropriate selection of bone markers in romosozumab treatment for osteoporosis patients: a 6-month study. Osteoporos Int. 2020; 32(4):653-661. DOI: 10.1007/s00198-020-05639-y. View

11.

Mariscal G, Nunez J, Bhatia S, Barrios C, Domenech-Fernandez P . Safety of Romosozumab in Osteoporotic Men and Postmenopausal Women: A Meta-Analysis and Systematic Review. Monoclon Antib Immunodiagn Immunother. 2020; 39(2):29-36. DOI: 10.1089/mab.2019.0049. View

12.

Li X, Warmington K, Niu Q, Asuncion F, Barrero M, Grisanti M . Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass, and bone strength in aged male rats. J Bone Miner Res. 2010; 25(12):2647-56. DOI: 10.1002/jbmr.182. View

13.

Veitch S, Findlay S, Hamer A, Blumsohn A, Eastell R, Ingle B . Changes in bone mass and bone turnover following tibial shaft fracture. Osteoporos Int. 2005; 17(3):364-72. DOI: 10.1007/s00198-005-2025-y. View

14.

McClung M, Grauer A, Boonen S, Bolognese M, Brown J, Diez-Perez A . Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014; 370(5):412-20. DOI: 10.1056/NEJMoa1305224. View

15.

Ominsky M, Vlasseros F, Jolette J, Smith S, Stouch B, Doellgast G . Two doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength. J Bone Miner Res. 2010; 25(5):948-59. DOI: 10.1002/jbmr.14. View

16.

Cavalier E, Souberbielle J, Gadisseur R, Dubois B, Krzesinski J, Delanaye P . Inter-method variability in bone alkaline phosphatase measurement: clinical impact on the management of dialysis patients. Clin Biochem. 2014; 47(13-14):1227-30. DOI: 10.1016/j.clinbiochem.2014.04.007. View

17.

Nishizawa Y, Miura M, Ichimura S, Inaba M, Imanishi Y, Shiraki M . Executive summary of the Japan Osteoporosis Society Guide for the Use of Bone Turnover Markers in the Diagnosis and Treatment of Osteoporosis (2018 Edition). Clin Chim Acta. 2019; 498:101-107. DOI: 10.1016/j.cca.2019.08.012. View

18.

Polyzos S, Anastasilakis A, Terpos E . Transient secondary hyperparathyroidism following intravenous infusion of zoledronic acid. Support Care Cancer. 2009; 17(10):1329-30. DOI: 10.1007/s00520-009-0704-5. View

19.

Fogelman I, Blake G . Different approaches to bone densitometry. J Nucl Med. 2001; 41(12):2015-25. View

20.

Ebina K, Hirao M, Tsuboi H, Nagayama Y, Kashii M, Kaneshiro S . Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis. Bone. 2020; 140:115574. DOI: 10.1016/j.bone.2020.115574. View