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Бисфосфонаты: 50 лет в медицинской практике
Бисфосфонаты: 50 лет в медицинской практике
Голоунина О.О., Белая Ж.Е. Бисфосфонаты: 50 лет в медицинской практике. Consilium Medicum. 2020; 22 (4): 66–73. DOI: 10.26442/20751753.2020.4.200102
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Аннотация
Бисфосфонаты (БФ) активно используются в медицине с конца 1960-х годов, 50-летний клинический опыт свидетельствует об их успешном применении в профилактике и лечении остеопороза у мужчин и женщин, болезни Педжета, у больных с костными метастазами злокачественных опухолей. Доказательства эффективности и безопасности данного класса препаратов получены и подтверждены многочисленными исследованиями и многолетней клинической практикой. Основной фармакологический эффект БФ заключается в снижении скорости костного ремоделирования с замедлением фазы костной резорбции. Кроме того, согласно результатам ряда исследований, БФ могут оказывать дополнительное влияние на выживаемость пациентов после перелома бедра. В настоящее время активно используются азотсодержащие БФ, к которым относятся алендроновая, ризедроновая, ибандроновая и золедроновая кислоты. Серьезные нежелательные явления, связанные с приемом БФ, возникают довольно редко, а соблюдение инструкции позволяет свести их к минимуму. После закрытия патентной защиты ключевых БФ были созданы их генерики, которые в настоящее время широко применяются в мировой практике и в Российской Федерации. В 2020 г. стали доступны новые генерики российского производства: Резовива (ибандроновая кислота 3 мг для внутривенного введения 1 раз в 3 мес) и Остеостатикс (золедроновая кислота 5 мг 100 мл раствора для внутривенного капельного введения 1 раз в год). Таким образом, БФ остаются эффективными и безопасными препаратами для лечения и профилактики остеопороза, а также ряда других заболеваний скелета. Появление генериков этих препаратов позволяет добиться повышения доступности этих лекарственных средств как для индивидуального пациента, так и для системы здравоохранения.
Ключевые слова: бисфосфонаты, алендронат, ризедронат, ибандронат, золедроновая кислота, генерики, остеопороз, болезнь Педжета, костные метастазы, Резовива, Остеостатикс.
Key words: bisphosphonates, alendronate, risedronate, ibandronate, zoledronic acid, generics, osteoporosis, Paget's disease, bone metastases.
Ключевые слова: бисфосфонаты, алендронат, ризедронат, ибандронат, золедроновая кислота, генерики, остеопороз, болезнь Педжета, костные метастазы, Резовива, Остеостатикс.
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Key words: bisphosphonates, alendronate, risedronate, ibandronate, zoledronic acid, generics, osteoporosis, Paget's disease, bone metastases.
Полный текст
Список литературы
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2. Smith R, Russell RG, Bishop M. Diphosphonates and Page’s disease of bone. Lancet 1971; 1 (7706): 945–7. DOI: 10.1016/s0140-6736(71)91447-4
3. Drake MT, Clarke BL, Khosla S. Bisphosphonates: mechanism of action and role in clinical practice. Mayo Clin Proc 2008; 83 (9): 1032–45. DOI: 10.4065/83.9.1032
4. Menschutkin N. Ueber die Einwirkung des Chloracetyls auf phosphorige Säure. Ann Chem Pharm 1865; 133 (3): 317–20. DOI: 10.1002/jlac.18651330307
5. Fleisch H, Russell RG, Francis MD. Diphosphonates inhibit hydroxyapatite dissolution in vitro and bone resorption in tissue culture and in vivo. Science 1969; 165 (3899): 1262–4. DOI: 10.1126/science.165.3899.1262
6. Russell RGG, Bisaz S, Donath A et al. Inorganic pyrophosphate in plasma in normal persons and in patients with hypophosphatasia, osteogenesis imperfecta, and other disorders of bone. J Clin Invest 1971; 50 (5): 961–9. DOI: 10.1172/JCI106589
7. Russell RG, Croucher PI, Rogers MJ. Bisphosphonates: pharmacology, mechanisms of action and clinical uses. Osteoporos Int 1999; 9 (Suppl. 2): 66–80. DOI: 10.1007/pl00004164
8. Rogers MJ, Crockett JC, Coxon FP et al. Biochemical and molecular mechanisms of action of bisphosphonates. Bone 2011; 49 (1): 34–41. DOI: 10.1016/j.bone.2010.11.008
9. Roelofs AJ, Thompson K, Gordon S et al. Molecular mechanisms of action of bisphosphonates: current status. Clin Cancer Res 2006; 12 (20 Pt 2): 6222–30. DOI: 10.1158/1078-0432.CCR-06-0843
10. Lehenkari PP, Kellinsalmi M, Näpänkangas JP et al. Further insight into mechanism of action of clodronate: inhibition of mitochondrial ADP/ATP translocase by a nonhydrolyzable, adenine-containing metabolite. Mol Pharmacol 2002; 61 (5): 1255–62. DOI: 10.1124/mol.61.5.1255
11. Russell RGG, Watts NB, Ebetino FH et al. Mechanisms of action of bisphosphonates: similarities and differences and their potential influence on clinical efficacy. Osteoporos Int 2008; 19 (6): 733–59. DOI: 10.1007/s00198-007-0540-8
12. Thompson K, Rogers MJ, Coxon FP et al. Cytosolic entry of bisphosphonate drugs requires acidification of vesicles after fluid-phase endocytosis. Mol Pharmacol 2006; 69 (5): 1624–32. DOI: 10.1124/mol.105.020776
13. Idris AI, Rojas J, Greig IR et al. Aminobisphosphonates cause osteoblast apoptosis and inhibit bone nodule formation in vitro. Calcif Tissue Int 2008; 82 (3): 191–201. DOI: 10.1007/s00223-008-9104-y
14. Gong L, Altman RB, Klein TE. Bisphosphonates pathway. Pharmacogenet Genomics 2011; 21 (1): 50–3. DOI: 10.1097/FPC.0b013e328335729c
15. Belaia Zh.E., Rozhinskaia L.Ia. Vitamin D v terapii osteoporoza: ego rol' v kombinatsii s preparatami dlia lecheniia osteoporoza, vneskeletnye effekty. Effektivnaia farmakoterapiia. 2013; 38: 14–29 (in Russian).
16. Ершова О.Б. Применение алендроната в терапии остеопороза. Ревматология. 2019; (21): 142–6. DOI: 10.21518/2079-701X-2019-21-142-146
[Ershova O.B. Primenenie alendronata v terapii osteoporoza. Revmatologiia. 2019; (21): 142–6. DOI: 10.21518/2079-701X-2019-21-142-146 (in Russian).]
17. Pols HA, Felsenberg D, Hanley DA et al. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group. Osteoporos Int 1999; 9 (5): 461–8. DOI: 10.1007/pl00004171
18. Black DM, Thompson DE, Bauer DC et al. Fracture Intervention Trial Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 2000; 85 (11): 4118–24. DOI: 10.1210/jcem.85.11.6953
19. Black DM, Schwartz AV, Ensrud KE et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 2006; 296 (24): 2927–38. DOI: 10.1001/jama.296.24.2927
20. Wang Y-K, Zhang Y-M, Qin S-Q et al. Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials. Medicine (Baltimore) 2018; 97 (42): e12691. DOI: 10.1097/MD.0000000000012691
21. Belaia Zh.E., Rozhinskaia L.Ia., Kolesnikova G.S. et al. Opyt primeneniia profilakticheskoi dozy alendronata (Fosamaks 35 mg) dlia lecheniia osteoporoza u zhenshchin v postmenopauze s subklinicheskim tireotoksikozom. Osteoporoz i osteopatii. 2007; 1: 12–9 (in Russian).
22. Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999; 282 (14): 1344–52. DOI: 10.1001/jama.282.14.1344
23. Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000; 11 (1): 83–91. DOI: 10.1007/s001980050010
24. Chesnut CH, Skag A, Christiansen C et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004; 19 (8): 1241–9. DOI: 10.1359/JBMR.040325
25. Epstein S, Jeglitsch M, McCloskey E. Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg. Curr Med Res Opin 2009; 25 (12): 2951–60. DOI: 10.1185/03007990903361307
26. Belaia Zh.E., Rozhinskaia L.Ia., Mel'nichenko G.A. Ibandronat (Bonviva) – novye vozmozhnosti v lechenii osteoporoza: povyshenie priverzhennosti k terapii – optimizatsiia iskhodov lecheniia. Osteoporoz i osteopatii. 2006; 9 (3): 23–30 (in Russian).
27. Belaia Zh.E., Rozhinskaia L.Ia. Ratsional'nyi vybor farmakoterapii postmenopauzal'nogo osteoporoza. Effektivnost' i bezopasnost' Bonvivy: obzor za vosem' let primeneniia. Osteoporoz i osteopatii. 2013; 2: 22–8 (in Russian).
28. Cranney A, Wells GA, Yetisir E et al. Ibandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data. Osteoporos Int 2009; 20 (2): 291–7. DOI: 10.1007/s00198-008-0653-8
29. Vorotnikova S.Iu., Pigarova E.A. Zoledronovaia kislota v lechenii osteoporoza i drugikh zabolevanii skeleta. Osteoporoz i osteopatii. 2016; 3: 23–7 (in Russian).
30. Geusens PPMM, Lems WF. Fracture prevention in postmenopausal women with osteoporosis by an annual infusion of zoledronic acid. Ned Tijdschr Geneeskd 2007; 151 (26): 1445–8.
31. McClung M, Miller P, Recknor C et al. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol 2009; 114 (5): 999–1007. DOI: 10.1097/AOG.0b013e3181bdce0a
32. Reid IR, Horne AM, Mihov B et al. Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med 2018; 379 (25): 2407–16. DOI: 10.1056/NEJMoa1808082
33. Rozhinskaia L.Ia. Bolezn' Pedzheta. Osteoporoz i osteopatii. 2007; 2: 29–31 (in Russian).
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35. Sharma A, Sinha RJ, Garg G et al. Special emphasis on bone health management in prostate cancer patients: a prospective longitudinal study. Int Braz J Urol 2020; 46 (3): 363–73. DOI: 10.1590/S1677-5538.IBJU.2019.0023
36. Jeon H-L, Oh I-S, Baek Y-H et al. Zoledronic acid and skeletal-related events in patients with bone metastatic cancer or multiple myeloma. J Bone Miner Metab 2020; 38 (2): 254–63. DOI: 10.1007/s00774-019-01052-6
37. Kulieva I.E., Besova N.S. Opyt primeneniia zoledronovoi kisloty (preparata Rezorba) dlia lecheniia bol'nykh s kostnymi metastazami. Effektivnaia farmakoterapiia. 2012; 37 (2): 24–31 (in Russian)
38. Sierra M, Alvarado M. Ramírez M et al. Hypercalcemia of Malignancy in a Patient with Hypoparathyroidism: A Complicated but Treatable Condition. P R Health Sci J 2019; 38 (4): 275–7.
39. Recine F, Bongiovanni A, Foca F et al. BOne HEalth ManagEment in Patients with Early Breast Cancer: A Retrospective Italian Osteoncology Center “Real-Life” Experience (BOHEME Study).
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40. Eguia A, Bagán-Debón L, Cardona F. Review and update on drugs related to the development of osteonecrosis of the jaw. Med Oral 2020: 71–83. DOI: 10.4317/medoral.23191
41. Jung S-M, Han S, Kwon H-Y. Dose-Intensity of Bisphosphonates and the Risk of Osteonecrosis of the Jaw in Osteoporosis Patients. Front Pharmacol 2018; 9: 796. DOI: 10.3389/fphar.2018.00796
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9. Roelofs AJ, Thompson K, Gordon S et al. Molecular mechanisms of action of bisphosphonates: current status. Clin Cancer Res 2006; 12 (20 Pt 2): 6222–30. DOI: 10.1158/1078-0432.CCR-06-0843
10. Lehenkari PP, Kellinsalmi M, Näpänkangas JP et al. Further insight into mechanism of action of clodronate: inhibition of mitochondrial ADP/ATP translocase by a nonhydrolyzable, adenine-containing metabolite. Mol Pharmacol 2002; 61 (5): 1255–62. DOI: 10.1124/mol.61.5.1255
11. Russell RGG, Watts NB, Ebetino FH et al. Mechanisms of action of bisphosphonates: similarities and differences and their potential influence on clinical efficacy. Osteoporos Int 2008; 19 (6): 733–59. DOI: 10.1007/s00198-007-0540-8
12. Thompson K, Rogers MJ, Coxon FP et al. Cytosolic entry of bisphosphonate drugs requires acidification of vesicles after fluid-phase endocytosis. Mol Pharmacol 2006; 69 (5): 1624–32. DOI: 10.1124/mol.105.020776
13. Idris AI, Rojas J, Greig IR et al. Aminobisphosphonates cause osteoblast apoptosis and inhibit bone nodule formation in vitro. Calcif Tissue Int 2008; 82 (3): 191–201. DOI: 10.1007/s00223-008-9104-y
14. Gong L, Altman RB, Klein TE. Bisphosphonates pathway. Pharmacogenet Genomics 2011; 21 (1): 50–3. DOI: 10.1097/FPC.0b013e328335729c
15. Белая Ж.Е., Рожинская Л.Я. Витамин D в терапии остеопороза: его роль в комбинации с препаратами для лечения остеопороза, внескелетные эффекты. Эффективная фармакотерапия. 2013; 38: 14–29.
[Belaia Zh.E., Rozhinskaia L.Ia. Vitamin D v terapii osteoporoza: ego rol' v kombinatsii s preparatami dlia lecheniia osteoporoza, vneskeletnye effekty. Effektivnaia farmakoterapiia. 2013; 38: 14–29 (in Russian).]
16. Ершова О.Б. Применение алендроната в терапии остеопороза. Ревматология. 2019; (21): 142–6. DOI: 10.21518/2079-701X-2019-21-142-146
[Ershova O.B. Primenenie alendronata v terapii osteoporoza. Revmatologiia. 2019; (21): 142–6. DOI: 10.21518/2079-701X-2019-21-142-146 (in Russian).]
17. Pols HA, Felsenberg D, Hanley DA et al. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group. Osteoporos Int 1999; 9 (5): 461–8. DOI: 10.1007/pl00004171
18. Black DM, Thompson DE, Bauer DC et al. Fracture Intervention Trial Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 2000; 85 (11): 4118–24. DOI: 10.1210/jcem.85.11.6953
19. Black DM, Schwartz AV, Ensrud KE et al. Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial. JAMA 2006; 296 (24): 2927–38. DOI: 10.1001/jama.296.24.2927
20. Wang Y-K, Zhang Y-M, Qin S-Q et al. Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials. Medicine (Baltimore) 2018; 97 (42): e12691. DOI: 10.1097/MD.0000000000012691
21. Белая Ж.Е., Рожинская Л.Я., Колесникова Г.С. и др. Опыт применения профилактической дозы алендроната (Фосамакс 35 мг) для лечения остеопороза у женщин в постменопаузе с субклиническим тиреотоксикозом. Остеопороз и остеопатии. 2007; 1: 12–9.
[Belaia Zh.E., Rozhinskaia L.Ia., Kolesnikova G.S. et al. Opyt primeneniia profilakticheskoi dozy alendronata (Fosamaks 35 mg) dlia lecheniia osteoporoza u zhenshchin v postmenopauze s subklinicheskim tireotoksikozom. Osteoporoz i osteopatii. 2007; 1: 12–9 (in Russian).]
22. Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999; 282 (14): 1344–52. DOI: 10.1001/jama.282.14.1344
23. Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000; 11 (1): 83–91. DOI: 10.1007/s001980050010
24. Chesnut CH, Skag A, Christiansen C et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004; 19 (8): 1241–9. DOI: 10.1359/JBMR.040325
25. Epstein S, Jeglitsch M, McCloskey E. Update on monthly oral bisphosphonate therapy for the treatment of osteoporosis: focus on ibandronate 150 mg and risedronate 150 mg. Curr Med Res Opin 2009; 25 (12): 2951–60. DOI: 10.1185/03007990903361307
26. Белая Ж.Е., Рожинская Л.Я., Мельниченко Г.А. Ибандронат (Бонвива) – новые возможности в лечении остеопороза: повышение приверженности к терапии – оптимизация исходов лечения. Остеопороз и остеопатии. 2006; 9 (3): 23–30.
[Belaia Zh.E., Rozhinskaia L.Ia., Mel'nichenko G.A. Ibandronat (Bonviva) – novye vozmozhnosti v lechenii osteoporoza: povyshenie priverzhennosti k terapii – optimizatsiia iskhodov lecheniia. Osteoporoz i osteopatii. 2006; 9 (3): 23–30 (in Russian).]
27. Белая Ж.Е., Рожинская Л.Я. Рациональный выбор фармакотерапии постменопаузального остеопороза. Эффективность и безопасность Бонвивы: обзор за восемь лет применения. Остеопороз и остеопатии. 2013; 2: 22–8.
[Belaia Zh.E., Rozhinskaia L.Ia. Ratsional'nyi vybor farmakoterapii postmenopauzal'nogo osteoporoza. Effektivnost' i bezopasnost' Bonvivy: obzor za vosem' let primeneniia. Osteoporoz i osteopatii. 2013; 2: 22–8 (in Russian).]
28. Cranney A, Wells GA, Yetisir E et al. Ibandronate for the prevention of nonvertebral fractures: a pooled analysis of individual patient data. Osteoporos Int 2009; 20 (2): 291–7. DOI: 10.1007/s00198-008-0653-8
29. Воротникова С.Ю., Пигарова Е.А. Золедроновая кислота в лечении остеопороза и других заболеваний скелета. Остеопороз и остеопатии. 2016; 3: 23–7.
[Vorotnikova S.Iu., Pigarova E.A. Zoledronovaia kislota v lechenii osteoporoza i drugikh zabolevanii skeleta. Osteoporoz i osteopatii. 2016; 3: 23–7 (in Russian).]
30. Geusens PPMM, Lems WF. Fracture prevention in postmenopausal women with osteoporosis by an annual infusion of zoledronic acid. Ned Tijdschr Geneeskd 2007; 151 (26): 1445–8.
31. McClung M, Miller P, Recknor C et al. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol 2009; 114 (5): 999–1007. DOI: 10.1097/AOG.0b013e3181bdce0a
32. Reid IR, Horne AM, Mihov B et al. Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med 2018; 379 (25): 2407–16. DOI: 10.1056/NEJMoa1808082
33. Рожинская Л.Я. Болезнь Педжета. Остеопороз и остеопатии. 2007; 2: 29–31.
[Rozhinskaia L.Ia. Bolezn' Pedzheta. Osteoporoz i osteopatii. 2007; 2: 29–31 (in Russian).]
34. Корсакова Ю.Л. Болезнь Педжета: современные методы лечения. Современная ревматология. 2010; 2: 11–7.
[Korsakova Iu.L. Bolezn' Pedzheta: sovremennye metody lecheniia. Sovremennaia revmatologiia. 2010; 2: 11–7 (in Russian)]
35. Sharma A, Sinha RJ, Garg G et al. Special emphasis on bone health management in prostate cancer patients: a prospective longitudinal study. Int Braz J Urol 2020; 46 (3): 363–73. DOI: 10.1590/S1677-5538.IBJU.2019.0023
36. Jeon H-L, Oh I-S, Baek Y-H et al. Zoledronic acid and skeletal-related events in patients with bone metastatic cancer or multiple myeloma. J Bone Miner Metab 2020; 38 (2): 254–63. DOI: 10.1007/s00774-019-01052-6
37. Кулиева И.Э., Бесова Н.С. Опыт применения золедроновой кислоты (препарата Резорба) для лечения больных с костными метастазами. Эффективная фармакотерапия. 2012; 37 (2): 24–31.
[Kulieva I.E., Besova N.S. Opyt primeneniia zoledronovoi kisloty (preparata Rezorba) dlia lecheniia bol'nykh s kostnymi metastazami. Effektivnaia farmakoterapiia. 2012; 37 (2): 24–31 (in Russian)]
38. Sierra M, Alvarado M. Ramírez M et al. Hypercalcemia of Malignancy in a Patient with Hypoparathyroidism: A Complicated but Treatable Condition. P R Health Sci J 2019; 38 (4): 275–7.
39. Recine F, Bongiovanni A, Foca F et al. BOne HEalth ManagEment in Patients with Early Breast Cancer: A Retrospective Italian Osteoncology Center “Real-Life” Experience (BOHEME Study).
J Clin Med 2019; 8 (11). DOI: 10.3390/jcm8111894
40. Eguia A, Bagán-Debón L, Cardona F. Review and update on drugs related to the development of osteonecrosis of the jaw. Med Oral 2020: 71–83. DOI: 10.4317/medoral.23191
41. Jung S-M, Han S, Kwon H-Y. Dose-Intensity of Bisphosphonates and the Risk of Osteonecrosis of the Jaw in Osteoporosis Patients. Front Pharmacol 2018; 9: 796. DOI: 10.3389/fphar.2018.00796
42. Meyyur Aravamudan V, Er C. Osteonecrosis of the Jaw and Concomitant Atypical Femoral Fractures with Bisphosphonates: A Comprehensive Literature Review. Cureus 2019; 11 (7): e5113. DOI: 10.7759/cureus.5113
43. Chan BH, Yee R, Puvanendran R et al. Medication-related osteonecrosis of the jaw in osteoporotic patients: prevention and management. Singapore Med J 2018; 59 (2): 70–5. DOI: 10.11622/smedj.2018014
44. Odvina CV, Zerwekh JE, Rao DS et al. Severely Suppressed Bone Turnover: A Potential Complication of Alendronate Therapy. J Clin Endocrinol Metab 2005; 90 (3): 1294–301. DOI: 10.1210/jc.2004-0952
45. Rizzoli R, Åkesson K, Bouxsein M et al. Subtrochanteric fractures after long-term treatment with bisphosphonates: a European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, and International Osteoporosis Foundation Working Group Report. Osteoporos Int 2011; 22 (2): 373–90. DOI: 10.1007/s00198-010-1453-5
46. Lloyd AA, Gludovatz B, Riedel C et al. Atypical fracture with long-term bisphosphonate therapy is associated with altered cortical composition and reduced fracture resistance. Proc Natl Acad Sci USA 2017; 114 (33): 8722–7. DOI: 10.1073/pnas.1704460114
47. Зоткина К.Е., Лесняк О.М., Кочиш А.Ю. и др. Атипичный перелом бедренной кости на фоне лечения бисфосфонатами пациентки с постменопаузальным остеопорозом. Остеопороз и остеопатии. 2019; 22 (1): 18–23. DOI: 10.14341/osteo10286
[Zotkina K.E., Lesniak O.M., Kochish A.Iu. et al. Atipichnyi perelom bedrennoi kosti na fone lecheniia bisfosfonatami patsientki s postmenopauzal'nym osteoporozom. Osteoporoz i osteopatii. 2019; 22 (1): 18–23. DOI: 10.14341/osteo10286 (in Russian).]
48. Starr J, Tay YKD, Shane E. Current Understanding of Epidemiology, Pathophysiology, and Management of Atypical Femur Fractures. Curr Osteoporos Rep 2018; 16 (4): 519–29. DOI: 10.1007/s11914-018-0464-6
49. Brock GR, Chen JT, Ingraffea AR et al. The Effect of Osteoporosis Treatments on Fatigue Properties of Cortical Bone Tissue. Bone Rep 2015; 2: 8–13. DOI: 10.1016/j.bonr.2014.10.004
50. Khow KSF, Shibu P, Yu SCY et al. Epidemiology and Postoperative Outcomes of Atypical Femoral Fractures in Older Adults: A Systematic Review. J Nutr Health Aging 2017; 21 (1): 83–91. DOI: 10.1007/s12603-015-0652-3
51. Dell RM, Adams AL, Greene DF et al. Incidence of atypical nontraumatic diaphyseal fractures of the femur. J Bone Miner Res 2012; 27 (12): 2544–50. DOI: 10.1002/jbmr.1719
52. Kharazmi M, Hallberg P, Schilcher J et al. Mortality After Atypical Femoral Fractures: A Cohort Study: MORTALITY AFTER ATYPICAL FEMORAL FRACTURES. J Bone Miner Res 2016; 31 (3): 491–7. DOI: 10.1002/jbmr.2767
53. Dennison EM, Cooper C, Kanis JA et al. Fracture risk following intermission of osteoporosis therapy. Osteoporos Int 2019; 30 (9): 1733–43. DOI: 10.1007/s00198-019-05002-w
54. Bone HG, Hosking D, Devogelaer J-P et al. Ten years’ experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004; 350 (12): 1189–99. DOI: 10.1056/NEJMoa030897
55. Black DM, Reid IR, Boonen S et al. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 2012; 27 (2): 243–54. DOI: 10.1002/jbmr.1494
56. Curtis J, Chen R, Li Z et al. The impact of bisphosphonate drug holidays on fracture rates. Abstract 1006 presented at the ASBMR meeting 2018.
57. Голоунина О.О., Белая Ж.Е., Мельниченко Г.А. Маркеры костного ремоделирования в клинической практике. Клиническая медицина. 2018; 96 (10): 876–84. DOI: 10.34651/0023-2149-2018-96-10-876-884
[Golounina O.O., Belaia Zh.E., Mel'nichenko G.A. Markery kostnogo remodelirovaniia v klinicheskoi praktike. Klinicheskaia meditsina. 2018; 96 (10): 876–84. DOI: 10.34651/0023-2149-2018-96-10-876-884 (in Russian).]
58. Lyles KW, Colón-Emeric CS, Magaziner JS et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007; 357 (18): 1799–809. DOI: 10.1056/NEJMoa074941
59. Cummings SR, Lui L-Y, Eastell R et al. Association Between Drug Treatments for Patients With Osteoporosis and Overall Mortality Rates: A Meta-analysis. JAMA Intern Med 2019. DOI: 10.1001/jamainternmed.2019.2779
60. Bliuc D, Tran T, van Geel T et al. Mortality risk reduction differs according to bisphosphonate class: a 15-year observational study. Osteoporos Int 2019; 30 (4): 817–28. DOI: 10.1007/s00198-018-4806-0
61. Lee P, Ng C, Slattery A et al. Preadmission Bisphosphonate and Mortality in Critically Ill Patients. J Clin Endocrinol Metab 2016; 101 (5): 1945–53. DOI: 10.1210/jc.2015-3467
62. Bergman J, Nordström A, Hommel A et al. Bisphosphonates and mortality: confounding in observational studies? Osteoporos Int 2019; 30 (10): 1973–82. DOI: 10.1007/s00198-019-05097-1
63. Скрипникова И.А., Рожинская Л.Я. Применение дженериков – способ повышения приверженности лечению остеопороза. Остеопороз и остеопатии. 2010; 13 (3): 36–40.
[Skripnikova I.A., Rozhinskaia L.Ia. Primenenie dzhenerikov – sposob povysheniia priverzhennosti lecheniiu osteoporoza. Osteoporoz i osteopatii. 2010; 13 (3): 36–40 (in Russian).]
64. Lai PSM, Chua SS, Chong YH et al. The effect of mandatory generic substitution on the safety of alendronate and patients’ adherence. Curr Med Res Opin 2012; 28 (8): 1347–55. DOI: 10.1185/03007995.2012.708326
65. Белая Ж.Е., Рожинская Л.Я. Дженерики в терапии постменопаузального остеопороза. РМЖ. 2010; 23: 14–9.
[Belaia Zh.E., Rozhinskaia L.Ia. Dzheneriki v terapii postmenopauzal'nogo osteoporoza. RMZh. 2010; 23: 14–9 (in Russian).]
66. Unnanuntana A, Jarusriwanna A, Songcharoen P. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment. PLoS ONE 2017; 12(7): e0180325. DOI: 10.1371/journal.pone.0180325
67. Древаль А.В., Марченкова Л.А., Бахарева И.В. и др. Анализ клинического опыта применения отечественного дженерика золедроновой кислоты для лечения остеопороза. Лечащий врач. 2014; 5: 124.
[Dreval' A.V., Marchenkova L.A., Bakhareva I.V. et al. Analiz klinicheskogo opyta primeneniia otechestvennogo dzhenerika zoledronovoi kisloty dlia lecheniia osteoporoza. Lechashchii vrach. 2014; 5: 124 (in Russian).]
________________________________________________
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36. Jeon H-L, Oh I-S, Baek Y-H et al. Zoledronic acid and skeletal-related events in patients with bone metastatic cancer or multiple myeloma. J Bone Miner Metab 2020; 38 (2): 254–63. DOI: 10.1007/s00774-019-01052-6
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38. Sierra M, Alvarado M. Ramírez M et al. Hypercalcemia of Malignancy in a Patient with Hypoparathyroidism: A Complicated but Treatable Condition. P R Health Sci J 2019; 38 (4): 275–7.
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J Clin Med 2019; 8 (11). DOI: 10.3390/jcm8111894
40. Eguia A, Bagán-Debón L, Cardona F. Review and update on drugs related to the development of osteonecrosis of the jaw. Med Oral 2020: 71–83. DOI: 10.4317/medoral.23191
41. Jung S-M, Han S, Kwon H-Y. Dose-Intensity of Bisphosphonates and the Risk of Osteonecrosis of the Jaw in Osteoporosis Patients. Front Pharmacol 2018; 9: 796. DOI: 10.3389/fphar.2018.00796
42. Meyyur Aravamudan V, Er C. Osteonecrosis of the Jaw and Concomitant Atypical Femoral Fractures with Bisphosphonates: A Comprehensive Literature Review. Cureus 2019; 11 (7): e5113. DOI: 10.7759/cureus.5113
43. Chan BH, Yee R, Puvanendran R et al. Medication-related osteonecrosis of the jaw in osteoporotic patients: prevention and management. Singapore Med J 2018; 59 (2): 70–5. DOI: 10.11622/smedj.2018014
44. Odvina CV, Zerwekh JE, Rao DS et al. Severely Suppressed Bone Turnover: A Potential Complication of Alendronate Therapy. J Clin Endocrinol Metab 2005; 90 (3): 1294–301. DOI: 10.1210/jc.2004-0952
45. Rizzoli R, Åkesson K, Bouxsein M et al. Subtrochanteric fractures after long-term treatment with bisphosphonates: a European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, and International Osteoporosis Foundation Working Group Report. Osteoporos Int 2011; 22 (2): 373–90. DOI: 10.1007/s00198-010-1453-5
46. Lloyd AA, Gludovatz B, Riedel C et al. Atypical fracture with long-term bisphosphonate therapy is associated with altered cortical composition and reduced fracture resistance. Proc Natl Acad Sci USA 2017; 114 (33): 8722–7. DOI: 10.1073/pnas.1704460114
47. Zotkina K.E., Lesniak O.M., Kochish A.Iu. et al. Atipichnyi perelom bedrennoi kosti na fone lecheniia bisfosfonatami patsientki s postmenopauzal'nym osteoporozom. Osteoporoz i osteopatii. 2019; 22 (1): 18–23. DOI: 10.14341/osteo10286 (in Russian).
48. Starr J, Tay YKD, Shane E. Current Understanding of Epidemiology, Pathophysiology, and Management of Atypical Femur Fractures. Curr Osteoporos Rep 2018; 16 (4): 519–29. DOI: 10.1007/s11914-018-0464-6
49. Brock GR, Chen JT, Ingraffea AR et al. The Effect of Osteoporosis Treatments on Fatigue Properties of Cortical Bone Tissue. Bone Rep 2015; 2: 8–13. DOI: 10.1016/j.bonr.2014.10.004
50. Khow KSF, Shibu P, Yu SCY et al. Epidemiology and Postoperative Outcomes of Atypical Femoral Fractures in Older Adults: A Systematic Review. J Nutr Health Aging 2017; 21 (1): 83–91. DOI: 10.1007/s12603-015-0652-3
51. Dell RM, Adams AL, Greene DF et al. Incidence of atypical nontraumatic diaphyseal fractures of the femur. J Bone Miner Res 2012; 27 (12): 2544–50. DOI: 10.1002/jbmr.1719
52. Kharazmi M, Hallberg P, Schilcher J et al. Mortality After Atypical Femoral Fractures: A Cohort Study: MORTALITY AFTER ATYPICAL FEMORAL FRACTURES. J Bone Miner Res 2016; 31 (3): 491–7. DOI: 10.1002/jbmr.2767
53. Dennison EM, Cooper C, Kanis JA et al. Fracture risk following intermission of osteoporosis therapy. Osteoporos Int 2019; 30 (9): 1733–43. DOI: 10.1007/s00198-019-05002-w
54. Bone HG, Hosking D, Devogelaer J-P et al. Ten years’ experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004; 350 (12): 1189–99. DOI: 10.1056/NEJMoa030897
55. Black DM, Reid IR, Boonen S et al. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 2012; 27 (2): 243–54. DOI: 10.1002/jbmr.1494
56. Curtis J, Chen R, Li Z et al. The impact of bisphosphonate drug holidays on fracture rates. Abstract 1006 presented at the ASBMR meeting 2018.
57. Golounina O.O., Belaia Zh.E., Mel'nichenko G.A. Markery kostnogo remodelirovaniia v klinicheskoi praktike. Klinicheskaia meditsina. 2018; 96 (10): 876–84. DOI: 10.34651/0023-2149-2018-96-10-876-884 (in Russian).
58. Lyles KW, Colón-Emeric CS, Magaziner JS et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007; 357 (18): 1799–809. DOI: 10.1056/NEJMoa074941
59. Cummings SR, Lui L-Y, Eastell R et al. Association Between Drug Treatments for Patients With Osteoporosis and Overall Mortality Rates: A Meta-analysis. JAMA Intern Med 2019. DOI: 10.1001/jamainternmed.2019.2779
60. Bliuc D, Tran T, van Geel T et al. Mortality risk reduction differs according to bisphosphonate class: a 15-year observational study. Osteoporos Int 2019; 30 (4): 817–28. DOI: 10.1007/s00198-018-4806-0
61. Lee P, Ng C, Slattery A et al. Preadmission Bisphosphonate and Mortality in Critically Ill Patients. J Clin Endocrinol Metab 2016; 101 (5): 1945–53. DOI: 10.1210/jc.2015-3467
62. Bergman J, Nordström A, Hommel A et al. Bisphosphonates and mortality: confounding in observational studies? Osteoporos Int 2019; 30 (10): 1973–82. DOI: 10.1007/s00198-019-05097-1
63. Skripnikova I.A., Rozhinskaia L.Ia. Primenenie dzhenerikov – sposob povysheniia priverzhennosti lecheniiu osteoporoza. Osteoporoz i osteopatii. 2010; 13 (3): 36–40 (in Russian).
64. Lai PSM, Chua SS, Chong YH et al. The effect of mandatory generic substitution on the safety of alendronate and patients’ adherence. Curr Med Res Opin 2012; 28 (8): 1347–55. DOI: 10.1185/03007995.2012.708326
65. Belaia Zh.E., Rozhinskaia L.Ia. Dzheneriki v terapii postmenopauzal'nogo osteoporoza. RMZh. 2010; 23: 14–9 (in Russian).
66. Unnanuntana A, Jarusriwanna A, Songcharoen P. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment. PLoS ONE 2017; 12(7): e0180325. DOI: 10.1371/journal.pone.0180325
67. Dreval' A.V., Marchenkova L.A., Bakhareva I.V. et al. Analiz klinicheskogo opyta primeneniia otechestvennogo dzhenerika zoledronovoi kisloty dlia lecheniia osteoporoza. Lechashchii vrach. 2014; 5: 124 (in Russian).
Авторы
О.О. Голоунина*1, Ж.Е. Белая2
1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр эндокринологии» Минздрава России, Москва, Россия
*olga.golounina@mail.ru
1 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
2 Endocrinology Research Centre, Moscow, Russia
olga.golounina@mail.ru
1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
2 ФГБУ «Национальный медицинский исследовательский центр эндокринологии» Минздрава России, Москва, Россия
*olga.golounina@mail.ru
________________________________________________
1 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
2 Endocrinology Research Centre, Moscow, Russia
olga.golounina@mail.ru
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