Skip to main content
Top
Published in: Clinical Rheumatology 11/2020

01-11-2020 | Osteoporosis | Review Article

Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis

Authors: Sara Kaveh, Hossein Hosseinifard, Nashmil Ghadimi, Mahdi Vojdanian, Aidin Aryankhesal

Published in: Clinical Rheumatology | Issue 11/2020

Login to get access

Abstract

Osteoporosis is a chronic skeletal disease with an increasing prevalence. Romosozumab, as a monoclonal anti-sclerostin antibody with a dual function, has been produced. In this meta-analysis, we aimed to examine the efficacy of Romosozumab in patients with low bone mineral density. A systematic search was conducted in the most important electronic search engines like Cochrane Library, PubMed, Web of Science, Scopus, Google Scholar, and ClinicalTrials.​gov at the end of July 2019 to retrieve randomized controlled trials (RCTs), which evaluated the effect of Romosozumab in patients with osteoporosis and/or low bone mineral density. After evaluating the quality of articles with the Cochrane checklist, data related to the outcomes of bone mineral density (BMD) of lumbar spine, femoral neck, and total hip, risk of clinical, vertebral and non-vertebral fractures, and risk of adverse events were extracted. Quality of evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Heterogeneity between studies was evaluated by I2 and Q statistics. The meta-analysis was performed using CMA v.2.0 software. Of all the 671 initially retrieved articles, seven articles were entered into the meta-analysis after removing duplicates and reviewing papers with inclusion and exclusion criteria. The results of the meta-analysis showed that Romosozumab 210, 140, and 70 mg compared with Alendronate, Teriparatide, and placebo can increase the bone mineral density in the lumbar spine, femoral neck, and total hip. The risk of adverse events like adjudicated cardiovascular serious adverse events and adjudicated cardiovascular death was more in Romosozumab 210 mg in comparison with placebo. However, this difference was not statistically significant. Treatment with anti-sclerostin antibodies can be a proper therapeutic option in patients with osteoporosis and low bone mineral density. Based on the results of this meta-analysis, it seems that Romosozumab, with its dual function, has a positive role in the treatment of osteoporosis and low bone mineral density.
Appendix
Available only for authorised users
Literature
1.
go back to reference Papapoulos S, Lippuner K, Roux C, Lin CJ, Kendler DL, Lewiecki EM, Brandi ML, Czerwinski E, Franek E, Lakatos P, Mautalen C, Minisola S, Reginster JY, Jensen S, Daizadeh NS, Wang A, Gavin M, Libanati C, Wagman RB, Bone HG (2015) The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM extension study. Osteoporos Int 26(12):2773–2783. https://doi.org/10.1007/s00198-015-3234-7CrossRefPubMedPubMedCentral Papapoulos S, Lippuner K, Roux C, Lin CJ, Kendler DL, Lewiecki EM, Brandi ML, Czerwinski E, Franek E, Lakatos P, Mautalen C, Minisola S, Reginster JY, Jensen S, Daizadeh NS, Wang A, Gavin M, Libanati C, Wagman RB, Bone HG (2015) The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM extension study. Osteoporos Int 26(12):2773–2783. https://​doi.​org/​10.​1007/​s00198-015-3234-7CrossRefPubMedPubMedCentral
5.
go back to reference Bello MO, Garla VV (2019) Osteoporosis in males. In: StatPearls [internet]. StatPearls Publishing Bello MO, Garla VV (2019) Osteoporosis in males. In: StatPearls [internet]. StatPearls Publishing
6.
go back to reference Orive M, Aguirre U, Garcia-Gutierrez S, Las Hayas C, Bilbao A, Gonzalez N, Zabala J, Navarro G, Quintana JM (2015) Changes in health-related quality of life and activities of daily living after hip fracture because of a fall in elderly patients: a prospective cohort study. Int J Clin Pract 69(4):491–500. https://doi.org/10.1111/ijcp.12527CrossRefPubMed Orive M, Aguirre U, Garcia-Gutierrez S, Las Hayas C, Bilbao A, Gonzalez N, Zabala J, Navarro G, Quintana JM (2015) Changes in health-related quality of life and activities of daily living after hip fracture because of a fall in elderly patients: a prospective cohort study. Int J Clin Pract 69(4):491–500. https://​doi.​org/​10.​1111/​ijcp.​12527CrossRefPubMed
11.
go back to reference Tella SH, Gallagher JC (2014) Biological agents in management of osteoporosis. Eur J Clin Pharmacol 70(11):1291–1301CrossRefPubMed Tella SH, Gallagher JC (2014) Biological agents in management of osteoporosis. Eur J Clin Pharmacol 70(11):1291–1301CrossRefPubMed
12.
go back to reference Tu KN, Lie JD, Wan CKV, Cameron M, Austel AG, Nguyen JK, Van K, Hyun D (2018) Osteoporosis: a review of treatment options. P T 43(2):92–104PubMedPubMedCentral Tu KN, Lie JD, Wan CKV, Cameron M, Austel AG, Nguyen JK, Van K, Hyun D (2018) Osteoporosis: a review of treatment options. P T 43(2):92–104PubMedPubMedCentral
16.
go back to reference Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A (2016) Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 375(16):1532–1543. https://doi.org/10.1056/NEJMoa1607948CrossRefPubMed Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A (2016) Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 375(16):1532–1543. https://​doi.​org/​10.​1056/​NEJMoa1607948CrossRefPubMed
19.
go back to reference Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A (2017) Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet 390(10102):1585–1594. https://doi.org/10.1016/s0140-6736(17)31613-6CrossRefPubMed Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A (2017) Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet 390(10102):1585–1594. https://​doi.​org/​10.​1016/​s0140-6736(17)31613-6CrossRefPubMed
20.
go back to reference Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S (2018) A phase III randomized placebo-controlled trial to evaluate efficacy and safety of Romosozumab in men with osteoporosis. J Clin Endocrinol Metab 103(9):3183–3193. https://doi.org/10.1210/jc.2017-02163CrossRefPubMed Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S (2018) A phase III randomized placebo-controlled trial to evaluate efficacy and safety of Romosozumab in men with osteoporosis. J Clin Endocrinol Metab 103(9):3183–3193. https://​doi.​org/​10.​1210/​jc.​2017-02163CrossRefPubMed
24.
go back to reference Glasser SP, Duval S (2014) Meta-analysis, evidence-based medicine, and clinical guidelines. In: Essentials of Clinical Research. Springer, pp 203–231 Glasser SP, Duval S (2014) Meta-analysis, evidence-based medicine, and clinical guidelines. In: Essentials of Clinical Research. Springer, pp 203–231
26.
go back to reference Higgins JP, Green S (2011) Cochrane handbook for systematic reviews of interventions, vol 4. Wiley Higgins JP, Green S (2011) Cochrane handbook for systematic reviews of interventions, vol 4. Wiley
27.
go back to reference Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, Muti P, Jaeschke R, Guyatt GH (2008) GRADE: assessing the quality of evidence for diagnostic recommendations. BMJ Evid Based Med 13(6):162–163CrossRef Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, Muti P, Jaeschke R, Guyatt GH (2008) GRADE: assessing the quality of evidence for diagnostic recommendations. BMJ Evid Based Med 13(6):162–163CrossRef
28.
go back to reference Deeks JJ, Higgins JP, Altman DG (2008) Analysing data and undertaking meta-analyses. In: Cochrane handbook for systematic reviews of interventions, pp 241–284 Deeks JJ, Higgins JP, Altman DG (2008) Analysing data and undertaking meta-analyses. In: Cochrane handbook for systematic reviews of interventions, pp 241–284
29.
go back to reference McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG (2014) Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 370(5):412–420. https://doi.org/10.1056/NEJMoa1305224CrossRefPubMed McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG (2014) Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 370(5):412–420. https://​doi.​org/​10.​1056/​NEJMoa1305224CrossRefPubMed
31.
go back to reference Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, Brown JP, Langdahl BL, Yan C, Grauer A, Libanati C (2017) Greater gains in spine and hip strength for Romosozumab compared with Teriparatide in postmenopausal women with low bone mass. J Bone Miner Res 32(9):1956–1962. https://doi.org/10.1002/jbmr.3176CrossRefPubMed Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, Brown JP, Langdahl BL, Yan C, Grauer A, Libanati C (2017) Greater gains in spine and hip strength for Romosozumab compared with Teriparatide in postmenopausal women with low bone mass. J Bone Miner Res 32(9):1956–1962. https://​doi.​org/​10.​1002/​jbmr.​3176CrossRefPubMed
34.
go back to reference Genant HK, Engelke K, Bolognese MA, Mautalen C, Brown JP, Recknor C, Goemaere S, Fuerst T, Yang YC, Grauer A, Libanati C (2017) Effects of Romosozumab compared with Teriparatide on bone density and mass at the spine and hip in postmenopausal women with low bone mass. J Bone Miner Res 32(1):181–187. https://doi.org/10.1002/jbmr.2932CrossRefPubMed Genant HK, Engelke K, Bolognese MA, Mautalen C, Brown JP, Recknor C, Goemaere S, Fuerst T, Yang YC, Grauer A, Libanati C (2017) Effects of Romosozumab compared with Teriparatide on bone density and mass at the spine and hip in postmenopausal women with low bone mass. J Bone Miner Res 32(1):181–187. https://​doi.​org/​10.​1002/​jbmr.​2932CrossRefPubMed
36.
go back to reference Ominsky MS, Boyd SK, Varela A, Jolette J, Felx M, Doyle N, Mellal N, Smith SY, Locher K, Buntich S, Pyrah I, Boyce RW (2017) Romosozumab improves bone mass and strength while maintaining bone quality in ovariectomized cynomolgus monkeys. J Bone Miner Res 32(4):788–801. https://doi.org/10.1002/jbmr.3036CrossRefPubMed Ominsky MS, Boyd SK, Varela A, Jolette J, Felx M, Doyle N, Mellal N, Smith SY, Locher K, Buntich S, Pyrah I, Boyce RW (2017) Romosozumab improves bone mass and strength while maintaining bone quality in ovariectomized cynomolgus monkeys. J Bone Miner Res 32(4):788–801. https://​doi.​org/​10.​1002/​jbmr.​3036CrossRefPubMed
37.
go back to reference Padhi D, Allison M, Kivitz AJ, Gutierrez MJ, Stouch B, Wang C, Jang G (2014) Multiple doses of sclerostin antibody romosozumab in healthy men and postmenopausal women with low bone mass: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol 54(2):168–178. https://doi.org/10.1002/jcph.239CrossRefPubMed Padhi D, Allison M, Kivitz AJ, Gutierrez MJ, Stouch B, Wang C, Jang G (2014) Multiple doses of sclerostin antibody romosozumab in healthy men and postmenopausal women with low bone mass: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol 54(2):168–178. https://​doi.​org/​10.​1002/​jcph.​239CrossRefPubMed
41.
go back to reference Balemans W, Ebeling M, Patel N, Van Hul E, Olson P, Dioszegi M, Lacza C, Wuyts W, Van Den Ende J, Willems P, Paes-Alves AF, Hill S, Bueno M, Ramos FJ, Tacconi P, Dikkers FG, Stratakis C, Lindpaintner K, Vickery B, Foernzler D, Van Hul W (2001) Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Hum Mol Genet 10(5):537–543. https://doi.org/10.1093/hmg/10.5.537CrossRefPubMed Balemans W, Ebeling M, Patel N, Van Hul E, Olson P, Dioszegi M, Lacza C, Wuyts W, Van Den Ende J, Willems P, Paes-Alves AF, Hill S, Bueno M, Ramos FJ, Tacconi P, Dikkers FG, Stratakis C, Lindpaintner K, Vickery B, Foernzler D, Van Hul W (2001) Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Hum Mol Genet 10(5):537–543. https://​doi.​org/​10.​1093/​hmg/​10.​5.​537CrossRefPubMed
44.
Metadata
Title
Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis
Authors
Sara Kaveh
Hossein Hosseinifard
Nashmil Ghadimi
Mahdi Vojdanian
Aidin Aryankhesal
Publication date
01-11-2020
Publisher
Springer International Publishing
Published in
Clinical Rheumatology / Issue 11/2020
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-020-04948-1

Other articles of this Issue 11/2020

Clinical Rheumatology 11/2020 Go to the issue