The Current Status of Sequential Therapy with Commonly Used Anti-Osteoporosis Drugs
Journal: Journal of Clinical Medicine Research DOI: 10.32629/jcmr.v5i2.2267
Abstract
As the trend of population aging intensifies, the incidence of osteoporosis is rising correspondingly. Osteoporotic fractures are one of the primary causes of disability and death in elderly patients, placing a great burden on both families and society in terms of medical care resources. The monotherapy of osteoporosis drugs has certain limitations and sequential drug treatment should be considered under the following circumstances: (i) when bone resorption inhibitors fail to work, have been used for too long, or cause adverse reactions; (ii) when the recommended treatment course of bone formation promoters (such as parathyroid hormone analogues) has ended but the patient's fracture risk remains high and requires continued treatment; (iii) when short-acting drugs such as teriparatide or denosumab need to maintain treatment effects after discontinuation. The sequential therapy of osteoporosis drugs can be categorized according to the mechanism of action into the following schemes: (i) bone formation promoters followed by bone resorption inhibitors; (ii) bone resorption inhibitors followed by bone formation promoters; (iii) different types of bone resorption inhibitors used sequentially; (iv) other sequential drug treatments. Osteoporosis is a progressive disease, and the ageing of the human population cannot be reversed. Therefore, single-drug treatment is unlikely to achieve the goal of long-term disease prevention and control, making the exploration of long-term treatment plans for existing drugs a key aspect of osteoporosis drug treatment.
Keywords
osteoporosis, sequential therapy, anti-osteoporosis drugs
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[51] Kocjan T, Rajic AS, Janez A, et al. Switching to denosumab or bisphosphonates after completion of teriparatide treatment in women with severe postmenopausal osteoporosis[J]. Endocr Pract, 2021, 27(9): 941-947.
[52] Eastell R, Nickelsen T, Marin F, et al. Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS)[J]. J Bone Miner Res, 2009, 24(4): 726-736.
[53] Cosman F, Nieves JW, Dempster DW. Treatment sequence matters: anabolic and antir esorptive therapy for osteoporosis[J]. J Bone Miner Res, 2017, 32(2): 198-202.
[54] Boonen S, Marin F, Obermayer-Pietsch B, et al. Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis[J]. J Clin Endocrinol Metab, 2008, 93(3): 852-860.
[55] Ettinger B, San Martin J, Crans G, et al. Differential effects of teriparatide on BMD after treatment with raloxifene or alendronate[J]. J Bone Miner Res, 2004, 19(5): 745-751.
[56] Kendler D, Chines A, Clark P, et al. Bone mineral density after transitioning from denosumab to alendronate[J]. J Clin Endocrinol Metab, 2020, 105(3): e255-e264.
[57] Everts-Graber J, Reichenbach S, Ziswiler HR, et al. A single infusion of zoledronate in postmenopausal women following denosumab discontinuation results in partial conservation of bone mass gains[J]. J Bone Miner Res, 2020, 35(7): 1207-1215.
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[61] Hong N, Shin S, Lee S, et al. Raloxifene use after denosumab discontinuation partially attenuates bone loss in the lumbar spine in postmenopausal osteoporosis[J]. Calcif Tissue Int, 2022, 111(1): 47-55.
[62] Oue T, Shimizu T, Asano T, et al. Comparison of the efficacy of zoledronate acid or denosumab after switching from romosozumab in Japanese postmenopausal patients[J]. Calcif Tissue Int, 2023, 112(6): 683-690.
[63] Cosman F, Kendler DL, Langdahl BL, et al. Romosozumab and antiresorptive treatment: the importance of treatment sequence[J]. Osteoporos Int, 2022, 33(6): 1243-1256.
[64] Kendler DL, Bone HG, Massari F, et al. Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab[J]. Osteoporos Int, 2019, 30(12): 2437-2448.
[2] Ling X, Cummings SR, Mingwei Q, et al. Vertebral fractures in Beijing, China: the Beijing Osteoporosis Project[J]. J Bone Miner Res. 2000;15(10):2019-2025.
[3] Wang L, Yu W, Yin X, et al. Prevalence of osteoporosis and fracture in China: the China Osteoporosis Prevalence Study[J].JAMA Netw Open, 2021, 4(8): e2121106.
[4] Siris ES, Adler R, Bilezikian J, et al. The clinical diagnosis of osteoporosis: a position statement from the National Bone Health Alliance Working Group[J]. Osteoporos Int. 2014;25(5):1439-1443.
[5] Xu L, Lu A, Zhao X, Chen X, Cummings SR. Very low rates of hip fracture in Beijing, People's Republic of China the Beijing Osteoporosis Project[J]. Am J Epidemiol. 1996;144(9):901-907.
[6] Cui L, Chen L, Xia W, et al. Vertebral fracture in postmenopausal Chinese women: a population-based study[J]. Osteoporos Int, 2017, 28(9): 2583-2590.
[7] Gao C, Xu Y, Li L, et al. Prevalence of osteoporotic vertebral fracture among community-dwelling elderly in Shanghai[J]. Chin Med J(Engl), 2019, 132(14):1749-1751.
[8] Xia W B, He S L, Xu L, et al. Rapidly increasing rates of hip fracture in Beijing, China. J Bone Miner Res[J]. 2012;27(1):125-129.
[9] Tian F M, Zhang L, Zhao H Y, et al. An increase in the incidence of hip fractures in Tangshan, China[J]. Osteoporos Int, 2014, 25(4):1321-1325.
[10] Wang J, Wang Y, Liu W D, et al. Hip fractures in Hefei, China: the Hefei osteoporosis project[J]. J Bone Miner Metab. 2014;32(2):206-214.
[11] Zhang C, Feng J, Wang S, et al. Incidence of and trends in hip fracture among adults in urban China: A nationwide retrospective cohort study[J]. PLoS Med. 2020;17(8):e1003180.
[12] Keene GS, Parker MJ, Pryor GA. Mortality and morbidity after hip fractures[J]. BMJ, 1993, 307(6914): 1248-1250.
[13] Osnes EK, Lofthus CM, Meyer HE, et al. Consequences of hip fracture on activities of daily life and residential needs[J]. Osteoporos Int. 2004;15(7): 567-574.
[14] Matsumoto T, Hagino H, Shiraki M, et al. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study[J]. Osteoporos Int, 2009, 20(8): 1429-1437.
[15] Boonen S, Reginster JY, Kaufman JM, et al. Fracture risk and zoledronic acid therapy in men with osteoporosis[J]. N Engl J Med, 2012, 367(18): 1714-1723.
[16] Allen CS, Yeung JH, Vandermeer B, et al. Bisphosphonates for steroid-induced osteoporosis[J]. Cochrane Database Syst Rev, 2016, 10(10): CD001347.
[17] Vahle JL, Long GG, Sandusky G, et al. Bone neoplasms in F344 rats given teriparatide[rhPTH(1-34)]are dependent on duration of treatment and dose[J]. Toxicol Pathol, 2004, 32(4): 426-438.
[18] Barrionuevo P, Kapoor E, Asi N, et al. Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women: a network meta-analysis[J]. J Clin Endocrinol Metab, 2019, 104(5): 1623-1630.
[19] Cummings SR, Martin JS, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis[J]. N Engl J Med, 2009, 361(8): 756-765.
[20] Bone HG, Wagman RB, Brandi ML, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension[J]. Lancet Diabetes Endocrinol, 2017, 5(7): 513-523.
[21] Langdahl BL, Teglbjærg CS, Ho PR, et al. A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: results from the ADAMO trial[J]. J Clin Endocrinol Metab, 2015, 100(4): 1335-1342.
[22] Saag KG, Wagman RB, Geusens P, et al. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study[J]. Lancet Diabetes Endocrinol, 2018, 6(6): 445-454.
[23] Yanbeiy ZA, Hansen KE. Denosumab in the treatment of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis[J]. Drug Des Devel Ther, 2019, 13: 2843-2852.
[24] Gnant M, Pfeiler G, Dubsky PC, et al. Adjuvant denosumab in breast cancer (ABCSG-18): a multicentre, randomised, double-blind, placebocontrolled trial[J]. Lancet, 2015, 386(9992): 433-443.
[25] Takeuchi T, Tanaka Y, Soen S, et al. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double -blind, placebo-controlled phase 3 trial[J]. Ann Rheum Dis, 2019, 78(7): 899-907.
[26] Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis[J]. N Engl J Med, 2001, 344(19): 1434-1441.
[27] Yuan F, Peng W, Yang CH, et al. Teriparatide versus bisphosphonates for treatment of postmenopausal osteoporosis: a meta -analysis[J]. Int J Surg, 2019, 66: 1-11.
[28] Díez-Pérez A, Marin F, Eriksen EF, et al. Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: a systematic review and meta-analysis[J]. Bone, 2019, 120: 1-8.
[29] Simpson EL, Martyn-St James M, Hamilton J, et al. Clinical effectiveness of denosumab, raloxifene, romosozumab, and teriparatide for the prevention of osteoporotic fragility fractures: a systematic review and network meta-analysis[J]. Bone, 2020, 130: 115081.
[30] Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide[human parathyroid hormone (1-34)]therapy on bone density in men with osteoporosis[J]. J Bone Miner Res, 2003, 18(1): 9-17.
[31] Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years[J]. J Bone Miner Res, 2012, 27(12): 2429-2437.
[32] Vahle JL, Sato M, Long GG, et al. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety[J]. Toxicol Pathol, 2002, 30(3): 312-321.
[33] Agnusdei D. Clinical efficacy of raloxifene in postmenopausal women[J]. Eur J Obstet Gynecol Reprod Biol, 1999, 85(1): 43-46.
[34] Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators[J]. JAMA, 1999, 282(7): 637-645.
[35] Buckley L, Guyatt G, Fink HA, et al. 2017 American college of rheumatology guideline for the prevention and treatment of glucocorticoid -induced osteoporosis[J]. Arthritis Rheumatol, 2017, 69(8): 1521-1537.
[36] Siris ES, Harris ST, Eastell R, et al. Skeletal effects of raloxifene after 8 years: results from the continuing outcomes relevant to Evista (CORE) study[J]. J Bone Miner Res, 2005, 20(9): 1514-1524.
[37] Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis[J]. N Engl J Med, 2016, 375(16): 1532-1543.
[38] Singh S, Dutta S, Khasbage S, et al. A systematic review and meta-analysis of efficacy and safety of Romosozumab in postmenopausal osteoporosis[J]. Osteoporos Int, 2022, 33(1): 1-12.
[39] Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis[J]. N Engl J Med, 2017, 377(15): 1417-1427.
[40] Lewiecki EM, Blicharski T, Goemaere S, et al. A phase III randomized placebo-controlled trial to evaluate efficacy and safety of romosozumab in men with osteoporosis[J]. J Clin Endocrinol Metab, 2018, 103(9): 3183-3193.
[41] Amgen. EVENITYTM (romosozumab-aqqg) injection. 2019[EB/OL]. (2019-12) [2023-05-26].
[42] Kaveh S, Hosseinifard H, Ghadimi N, et al. Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis[J]. Clin Rheumatol, 2020, 39(11): 3261-3276.
[43] British Society for Rheumatology. Amgen and UCB announce increased cardiovascular risk in patients receiving romosozumab, an antisclerotin antibody[J]. Rheumatology, 2017, 56(8): e21.
[44] Langdahl B. Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: combined and sequential approaches[J]. Bone, 2020, 139: 115516.
[45] Shane E, Shiau S, Recker RR, et al. Denosumab after teriparatide in premenopausal women with idiopathic osteoporosis[J]. J Clin Endocrinol Metab, 2022, 107(4): e1528-e1540.
[46] Leder BZ, Tsai JN, Uihlein AV, et al. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial[J]. Lancet, 2015, 386(9999): 1147-1155.
[47] Lindsay R, Scheele WH, Neer R, et al. Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis[J]. Arch Intern Med, 2004, 164(18): 2024-2030.
[48] Prince R, Sipos A, Hossain A, et al. Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment[J]. J Bone Miner Res, 2005, 20(9): 1507-1513.
[49] Niimi R, Kono T, Nishihara A, et al. Efficacy of switching from teriparatide to bisphosphonate or denosumab: a prospective, randomized, open-label trial[J]. JBMR Plus, 2018, 2(5): 289-294.
[50] Ebina K, Hashimoto J, Kashii M, et al. The effects of switching daily teriparatide to oral bisphosphonates or denosumab in patients with primary osteoporosis[J]. J Bone Miner Metab, 2017, 35(1): 91-98.
[51] Kocjan T, Rajic AS, Janez A, et al. Switching to denosumab or bisphosphonates after completion of teriparatide treatment in women with severe postmenopausal osteoporosis[J]. Endocr Pract, 2021, 27(9): 941-947.
[52] Eastell R, Nickelsen T, Marin F, et al. Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European Study of Forsteo (EUROFORS)[J]. J Bone Miner Res, 2009, 24(4): 726-736.
[53] Cosman F, Nieves JW, Dempster DW. Treatment sequence matters: anabolic and antir esorptive therapy for osteoporosis[J]. J Bone Miner Res, 2017, 32(2): 198-202.
[54] Boonen S, Marin F, Obermayer-Pietsch B, et al. Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis[J]. J Clin Endocrinol Metab, 2008, 93(3): 852-860.
[55] Ettinger B, San Martin J, Crans G, et al. Differential effects of teriparatide on BMD after treatment with raloxifene or alendronate[J]. J Bone Miner Res, 2004, 19(5): 745-751.
[56] Kendler D, Chines A, Clark P, et al. Bone mineral density after transitioning from denosumab to alendronate[J]. J Clin Endocrinol Metab, 2020, 105(3): e255-e264.
[57] Everts-Graber J, Reichenbach S, Ziswiler HR, et al. A single infusion of zoledronate in postmenopausal women following denosumab discontinuation results in partial conservation of bone mass gains[J]. J Bone Miner Res, 2020, 35(7): 1207-1215.
[58] Sølling AS, Harsløf T, Langdahl B. Treatment with zoledronate subsequent to denosumab in osteoporosis: a 2 -year randomized study[J]. J Bone Miner Res, 2021, 36(7): 1245-1254.
[59] Kondo H, Okimoto N, Yoshioka T, et al. Zoledronic acid sequential therapy could avoid disadvantages due to the discontinuation of less than 3-year denosumab treatment[J]. J Bone Miner Metab, 2020, 38(6): 894-902.
[60] Ha J, Kim J, Jeong C, et al. Effect of follow-up raloxifene therapy after denosumab discontinuation in postmenopausal women[J]. Osteoporos Int, 2022, 33(7): 1591-1599.
[61] Hong N, Shin S, Lee S, et al. Raloxifene use after denosumab discontinuation partially attenuates bone loss in the lumbar spine in postmenopausal osteoporosis[J]. Calcif Tissue Int, 2022, 111(1): 47-55.
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