https://doi.org/10.4081/reumatismo.2024.1696
Expert opinion on the management of patients with osteoporosis with anabolic drugs in Italy
Submitted: 8 January 2024
Accepted: 28 February 2024
Published: 24 June 2024
Accepted: 28 February 2024
Abstract Views: 2760
PDF: 1101
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Objective. Fragility fractures (FF) resulting from osteoporosis pose a significant public health challenge in Italy, with considerable socio-health and economic implications. Despite the availability of safe and effective drugs, osteoporosis remains underdiagnosed and undertreated, leaving over 2 million high-risk Italian women without treatment. This paper aims to identify and propose key improvements in the management of osteoporosis, focusing particularly on the critical issues related to the use of anabolic drugs in secondary prevention, according to the current Italian Medicines Agency (AIFA) Note 79.
Methods. The Expert Panel, composed of nine recognized Italian experts in rheumatology, analyzed current practices, prescribing criteria, and the most recent literature. Three main reasons for revising the indications on pharmacological treatment of osteoporosis were identified: inadequate treatment of osteoporosis, new evidence regarding frontline placement of anabolics in high-risk conditions, and emerging sequential or combined strategies.
Results. The proposed improvements include the adoption of the Derived Fracture Risk Assessment algorithm for accurate fracture risk assessment, revision of AIFA Note 79 to reflect current evidence, improved prescribing appropriateness, broader access to anabolic agents, and the provision of sequential therapies with antiresorptives for teriparatide. These changes aim to enhance patient outcomes, streamline healthcare processes, and address the high percentage of undertreated individuals.
Conclusions. This expert opinion emphasizes the importance of the appropriate use of anabolic drugs to reduce FF and associated costs while ensuring the sustainability of the National Health Service. The proposed recommendations are in line with the latest scientific evidence, providing a comprehensive strategy to optimize the management of osteoporosis in Italy.
On behalf of the Study Group on Osteoporosis and Skeletal Metabolic Diseases of the Italian Society of Rheumatology.
Borgström F, Karlsson L, Ortsäter G, Norton N, Halbout P, Cooper C, et al. Fragility fractures in Europe: burden, management and opportunities. Arch Osteoporos 2020; 15: 59.
DOI: https://doi.org/10.1007/s11657-020-0706-y
NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA 2001; 285: 785-95.
DOI: https://doi.org/10.1001/jama.285.6.785
Kanis JA, McCloskey EV, Johansson H, Oden A, Melton LJ 3rd, Khaltaev N. A reference standard for the description of osteoporosis. Bone 2008; 42: 467-75.
DOI: https://doi.org/10.1016/j.bone.2007.11.001
LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, et al. The clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int 2022: 33: 2049-102.
DOI: https://doi.org/10.1007/s00198-021-05900-y
Rossini M, Adami S, Bertoldo F, Diacinti D, Gatti D, Giannini S, et al. Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo 2016; 68: 1-39.
DOI: https://doi.org/10.4081/reumatismo.2016.870
Kanis JA, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, et al. SCOPE 2021: a new scorecard for osteoporosis in Europe. Arch Osteoporos 2021; 16: 82.
DOI: https://doi.org/10.1007/s11657-020-00871-9
ISTAT. 2022. Available from: http://dati.istat.it/viewhtml.aspx?il=blank&vh=0000&vf=0&vcq=1100&graph=0&lang=it&QueryId=15445.
Adami G, Tsourdi E, Rossini M, Funck-Brentano T, Chapurlat R. Patients with osteoporosis: children of a lesser god. RMD Open 2023; 9: e002973.
DOI: https://doi.org/10.1136/rmdopen-2022-002973
AIFA. Nota 79. 2022. Available from: https://www.aifa.gov.it/documents/20142/1728074/nota-79.pdf. [Text in Italian].
Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA 3rd, Berger M. Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res 2000; 15: 721-39
DOI: https://doi.org/10.1359/jbmr.2000.15.4.721
Adami G, Biffi A, Porcu G, Ronco R, Alvaro R, Bogini R, et al. A systematic review on the performance of fracture risk assessment tools: FRAX, DeFRA, FRA-HS. J Endocrinol Invest 2023; 46: 2287-97.
DOI: https://doi.org/10.1007/s40618-023-02082-8
AIFA. L’uso dei farmaci in Italia. Rapporto Nazionale anno 2022. Available from: https://www.aifa.gov.it/documents/20142/1967301/Rapporto-OsMed-2022.pdf. [Text in Italian]
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: 1-12.
DOI: https://doi.org/10.1007/s00198-019-05176-3
Curtis EM, Dennison EM, Cooper C, Harvey NC. Osteoporosis in 2022: care gaps to screening and personalised medicine. Best Pract Res Clin Rheumatol 2022; 36: 101754.
DOI: https://doi.org/10.1016/j.berh.2022.101754
ISS. Diagnosi, stratificazione del rischio e continuità assistenziale delle fratture da fragilità. 2021. Available from: https://www.iss.it/-/snlg-fratture-da-fragilita.
Corrao G, Biffi A, Porcu G, Ronco R, Adami G, Alvaro R, et al. Executive summary: Italian guidelines for diagnosis, risk stratification, and care continuity of fragility fractures 2021. Front Endocrinol (Lausanne) 2023; 14: 1137671.
DOI: https://doi.org/10.3389/fendo.2023.1137671
Bouxsein ML, Eastell R, Lui LY, Wu LA, de Papp AE, Grauer A, et al. Change in bone density and reduction in fracture risk: a meta-regression of published trials. J Bone Miner Res 2019; 34: 632-42.
DOI: https://doi.org/10.1002/jbmr.3641
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: 1417-27.
DOI: https://doi.org/10.1056/NEJMoa1708322
Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 2018; 391: 230-40.
DOI: https://doi.org/10.1016/S0140-6736(17)32137-2
Reid IR, Billington EO. Drug therapy for osteoporosis in older adults. Lancet 2022; 399: 1080-92.
DOI: https://doi.org/10.1016/S0140-6736(21)02646-5
Händel MN, Cardoso I, von Bülow C, Rohde JF, Ussing A, Nielsen SM, et al. Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials. BMJ 2023; 381: e068033.
DOI: https://doi.org/10.1136/bmj-2021-068033
Deardorff WJ, Cenzer I, Nguyen B, Lee SJ. Time to benefit of bisphosphonate therapy for the prevention of fractures among postmenopausal women with osteoporosis: a meta-analysis of randomized clinical trials. JAMA Intern Med 2022; 182: 33-41.
DOI: https://doi.org/10.1001/jamainternmed.2021.6745
Adami G, Fassio A, Gatti D, Viapiana O, Benini C, Maria I Danila MI, et al. Osteoporosis in 10 years time: a glimpse into the future of osteoporosis. Ther Adv Musculoskelet Dis 2022; 14: 1759720X221083541.
DOI: https://doi.org/10.1177/1759720X221083541
Cosman F, Nieves JW, Dempster DW. Treatment sequence matters: anabolic and antiresorptive therapy for osteoporosis. J Bone Min Res 2017, 32: 198-202.
DOI: https://doi.org/10.1002/jbmr.3051
Ramchand SK, Leder BZ. Sequential therapy for the long-term treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab 2024: 109: 303-11.
DOI: https://doi.org/10.1210/clinem/dgad496
Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, et al. T-Score as an indicator of fracture risk during treatment with romosozumab or alendronate in the ARCH trial. J Bone Miner Res 2020; 35: 1333-42.
DOI: https://doi.org/10.1002/jbmr.3996
Thomas T, Casado E, Geusens P, Lems WF, Timoshanko J, Taylor D, et al. Is a treat-to-target strategy in osteoporosis applicable in clinical practice? Consensus among a panel of European experts. Osteoporos Int 2020; 31: 2303-11.
DOI: https://doi.org/10.1007/s00198-020-05569-9
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: 1219-26.
DOI: https://doi.org/10.1002/jbmr.3427
Ebina K, Hashimoto J, Kashii M, Hirao M, Kaneshiro S, Takaaki Noguchi T, et al. The effects of switching daily teriparatide to oral bisphosphonates or denosumab in patients with primary osteoporosis. J. Bone Miner Metab 2017; 35: 91-8.
DOI: https://doi.org/10.1007/s00774-015-0731-x
Niimi R, Kono T, Nishihara A, Hasegawa M, Kono T, Sudo A. Efficacy of switching from teriparatide to bisphosphonate or denosumab: a prospective, randomized, open-label trial. JBMR Plus 2018; 2: 289-94.
DOI: https://doi.org/10.1002/jbm4.10054
Leder BZ, Tsai JN, Jiang LA, Lee H. Importance of prompt antiresorptive therapy in postmenopausal women discontinuing teriparatide or denosumab: the denosumab and teriparatide follow-up study (DATA-Follow-up). Bone 2017; 98: 54-8.
DOI: https://doi.org/10.1016/j.bone.2017.03.006
Idolazzi L, Rossini M, Viapiana O, Braga V, Fassio A, Benini C. Teriparatide and denosumab combination therapy and skeletal metabolism. Osteoporos Int 2016; 27: 3301-7.
DOI: https://doi.org/10.1007/s00198-016-3647-y
Leder BZ. Optimizing sequential and combined anabolic and antiresorptive osteoporosis therapy. JBMR Plus 2018; 2: 62-8.
DOI: https://doi.org/10.1002/jbm4.10041
Cosman F, Eriksen EF, Recknor C, Miller PD, Guañabens N, Kasperk C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res 2011; 26: 503-11.
DOI: https://doi.org/10.1002/jbmr.238
Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, et al. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet 2015; 386: 1147-55.
DOI: https://doi.org/10.1016/S0140-6736(15)61120-5
Kanis JA, McCloskey EV, Johansson H, Oden A, Ström O, Borgström F. Development and use of FRAX in osteoporosis. Osteoporos Int 2010; 21: S407-13.
DOI: https://doi.org/10.1007/s00198-010-1253-y
Kanis JA, Hans D, Cooper C, Baim S, Bilezikian JP, Binkley N, et al. Interpretation and use of FRAX in clinical practice. Osteoporos Int 2011; 22: 2395-411.
DOI: https://doi.org/10.1007/s00198-011-1713-z
Adami S, Bianchi G, Brandi ML, Di Munno O, Frediani B, Gatti D, et al. Validation and further development of the WHO 10-year fracture risk assessment tool in Italian postmenopausal women: project rationale and description. Clin Exp Rheumatol 2010; 28: 561-70.
Bonaccorsi G, Messina C, Cervellati C, Maietti E, Medini M, Rossini M, et al. Fracture risk assessment in postmenopausal women with diabetes: comparison between DeFRA and FRAX tools. Gynecol Endocrinol. 2018; 34: 404-8.
DOI: https://doi.org/10.1080/09513590.2017.1407308
Bonaccorsi G, Fila E, Cervellati C, Romani A, Giganti M, Rossini M, et al. Assessment of fracture risk in a population of postmenopausal Italian women: a comparison of two different tools. Calcif Tissue Int 2015; 97: 50-7.
DOI: https://doi.org/10.1007/s00223-015-0009-2
Ceccarelli F, Perricone C, Natalucci F, Picciariello L, Olivieri G, Cafaro G, et al. Organ damage in systemic lupus erythematosus patients: a multifactorial phenomenon. Autoimmun Rev 2023; 22: 103374.
DOI: https://doi.org/10.1016/j.autrev.2023.103374
Ministero della Salute – Consiglio Superiore di Sanità. Patologia ortopedica nelle condizioni di fragilità. Available from: https://www.salute.gov.it/imgs/C_17_pubblicazioni_3098_allegato.pdf. [Text in Italian].
Varenna M, Bertoldo F, Di Monaco M, Giusti A, Martini G, Rossini M. Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature. Reumatismo 2013; 65: 143-66.
DOI: https://doi.org/10.4081/reumatismo.2013.143
Rossini M, Adami G, Adami S, Viapiana O, Gatti D. Safety issues and adverse reactions with osteoporosis management. Expert Opin Drug Saf 2016; 15: 321-32.
DOI: https://doi.org/10.1517/14740338.2016.1136287
Gilsenan A, Midkiff K, Harris D, Kellier-Steele N, McSorley D, Andrews EB. Teriparatide did not increase adult osteosarcoma incidence in a 15-year US postmarketing surveillance study. J Bone Miner Res 2021; 36: 244-51.
DOI: https://doi.org/10.1002/jbmr.4188
McDonald CL, Johnson K, Alsoof D, Molino J, Balmaceno-Criss M, Daniels AH. Treatment of osteoporosis with anabolic agents and the risk of primary bone cancers: a study of 44,728 patients treated with teriparatide and abaloparatide. J Am Acad Orthop Surg 2023; 31: 520-8.
DOI: https://doi.org/10.5435/JAAOS-D-22-01094
Adami G, Giollo A, Rossini M, Orsolini G, Benini C, Viapiana O, et al. Different fracture risk profile in patients treated with anti-osteoporotic drugs in real-life. Reumatismo 2020; 72: 71-4.
DOI: https://doi.org/10.4081/reumatismo.2020.1267
How to Cite
Rossini, M., Cantatore, F., Del Puente, A., Frediani, B., Gatti, D., Giannini, S., … Sebastiani, G. (2024). Expert opinion on the management of patients with osteoporosis with anabolic drugs in Italy. Reumatismo, 76(2). https://doi.org/10.4081/reumatismo.2024.1696
Copyright (c) 2024 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
Similar Articles
- M. Ricci, G. De Marco, F. Desiati, D. Mazzocchi, L. Rotunno, N. Battafarano, A. Marchesoni, Long-term survival of methotrexate in psoriatic arthritis , Reumatismo: Vol. 61 No. 2 (2009)
- D. Jain, H.K. Aggarwal, V. Kaverappa, S. Dhayia, P. Jain, S. Yadav, Anti-dsDNA negative and anti-Ro positive lupus nephritis: a report of a rare case , Reumatismo: Vol. 65 No. 6 (2013)
- D.S. Meena, D. Kumar, G.K. Bohra, Acute severe gouty arthritis secondary to isotretinoin toxicity in a young male: a case report , Reumatismo: Vol. 75 No. 3 (2023)
You may also start an advanced similarity search for this article.
