porozendoОстеопороз и остеопатииOsteoporosis and Bone Diseases2072-26802311-0716Endocrinology Research Centre10.14341/osteo13146porozendo-13146Research ArticleНАУЧНЫЕ ОБЗОРЫREVIEWSОбзор существующих рекомендаций по перерыву в лечении-отмене бисфосфонатовReview of recommendations for bisphosphonate treatment interruption-discontinuationhttps://orcid.org/0000-0001-5906-9895ФоминыхМ. И.FominykhM. I.

Фоминых Мария Игоревна - к.м.н., доцент, кафедра факультетской терапии и гериатрии

620000, Екатеринбург, ул. Репина, д. 3.

Researcher ID: F-3811-2018

Maria I. Fominykh - MD, Cand.Sc., assistant professor.

3, Repina street, Ekaterinburg

Researcher ID F-3811-2018

fominykh_m@mail.ruhttps://orcid.org/0000-0003-4010-1888ЕвстигнееваЛ. П.EvstigneevaL. P.

Евстигнеева Людмила Петровна - д.м.н.

Екатеринбург

Lyudmila P. Evstigneeva – PhD.

Ekaterinburg

levstigneyeva@mail.ruФГБОУ ВО УГМУ Минздрава РоссииРоссияFederal State Budgetary Educational Institution of Higher Education USMU of the Ministry of Health of RussiaRussian FederationГАУЗ СО «Свердловская областная клиническая больница №1»РоссияGAUZ SO «Sverdlovskaya Regional Clinical Hospital No. 1»Russian Federation202317042024264813Copyright © Фоминых М.И., Евстигнеева Л.П., 20242024Фоминых М.И., Евстигнеева Л.П.Fominykh M.I., Evstigneeva L.P.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.osteo-endojournals.ru/jour/article/view/13146

Бисфосфонаты являются основными препаратами в лечении остеопороза, доказавшими свою эффективность в снижении риска переломов у пациентов с остеопорозом. Известно, что после лечения бисфосфонатами минеральная плотность костной ткани в течение определенного времени остается достаточно стабильной, также остаются сниженными маркеры костного метаболизма, что наряду с побочными эффектами длительной терапии бисфосфонатами определяет возможность «лекарственных каникул». В то же время во время перерыва в лечении бисфосфонатами начинает повышаться риск переломов, что является поводом для возобновления терапии. В настоящее время нет единых мировых данных по вопросам длительности лечения бисфосфонатами, начала «лекарственных каникул» и их продолжительности. Чтобы получить ответы на эти вопросы, нами проведена оценка существующих клинических рекомендаций по перерыву в лечении-отмене бисфосфонатов. Был проведен поиск литературы в базах данных: PubMed®, Кокрановская библиотека, веб-сайты крупных международных ассоциаций по остеопорозу, а также иной целенаправленный поиск в сети Интернет с ключевыми словами «Clinical Guideline of Osteoporosis», «Bisphosphonates», «Drug holidays in osteoporosis», «Discontinuation of bisphosphonates» за период с 1 января 2016 г. по 15 сентября 2023 г. Найдено 17 клинических рекомендаций, в которых имелась информация о перерыве в лечении и отмене бисфосфонатов.

Большинство клинических рекомендаций едины по вопросу начала «лекарственных каникул»: при умеренном риске переломов сделать перерыв в лечении таблетированными бисфосфонатами можно через 5 лет, после золедроновой кислоты — через 3 года терапии. При высоком и очень высоком риске переломов продолжительность лечения составляет 10 и 6 лет соответственно. Вопросы длительности «лекарственных каникул» различаются в рекомендациях, но в основе принятия решения в большинстве случаев лежит не срок, а оценка риска переломов при регулярной их переоценке, которая включает в себя предшествующие и новые низкоэнергетические переломы, появление новых факторов риска, снижение минеральной плотности кости, динамику костных маркеров, переоценку FRAX®.

Bisphosphonates are the main medications in the treatment of osteoporosis, which are effective in reducing the risk of fractures in patients with osteoporosis. It is known that after treatment with bisphosphonates, bone mineral density remains quite stable for a certain time, as well as markers of bone metabolism remain reduced, which, along with the side effects of long-term bisphosphonate therapy, determines the possibility of “Drug holidays”. At the same time, during a break in bisphosphonate treatment, the risk of fractures begins to increase, which is a reason to resume therapy.

Currently, there is no uniform worldwide data of starting a “drug holidays” on bisphosphonates. The duration of the “drug holidays” also differs in clinical recommendations from different countries. When to conduct a risk assessment of fractures during a “drug holidays”? To answer these questions, we assessed existing clinical recommendations for treatment interruption/discontinuation of bisphosphonates. A literature search was conducted using the following resources: PubMed®, the Cochrane Library, websites of major international osteoporosis associations, and other targeted Internet searches. The main search terms were “Clinical Guideline of Osteoporosis”, “Bisphosphonates”, “Drug holidays in osteoporosis”, “Discontinuation of bisphosphonates”. Тhe search was carried out using articles in Russian and English published between January 1, 2016 and September 15, 2023. 17 clinical guidelines from different countries (Russian, American, European, Asian and Australian) were found and analyzed in which was information about the break in the treatment and withdrawal of bisphosphonates.

The majority of clinical recommendations have the same opinion on the issue of starting “drug holidays”: with a moderate risk of fractures, you can take a break from treatment with tableted bisphosphonates after 5 years, after zoledronic acid — after 3 years of therapy. At high and very high risk of fractures, the duration of treatment is 10 and 6 years, respectively. The duration of “drug holidays” vary in the recommendations, but in most cases the decision-making is based not on the duration, but on the assessment of the risk of fractures with their regular reassessment, which includes previous and new low-energy fractures, the emergence of new risk factors, a decrease in BMD, the dynamics of bone markers, re-evalua­tion of FRAX®.

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The authors declare that there are no conflicts of interest present.