porozendoОстеопороз и остеопатииOsteoporosis and Bone Diseases2072-26802311-0716Endocrinology Research Centre10.14341/osteo13166porozendo-13166Research ArticleНАУЧНЫЕ ОБЗОРЫREVIEWSСуррогатные маркеры в оценке эффективности лечения остеопороза бисфосфонатами (минеральная плотность кости, маркеры костного обмена)Surrogate markers in assessment of bisphosphonate effectiveness in osteoporosis treatment (bone mineral density, bone turnover markers)https://orcid.org/0000-0002-6674-6441БелаяЖ. Е.BelayaZh. E.

Белая Жанна Евгеньевна - д.м.н.

Москва

Scopus Author ID 16506354000

Zhanna E. Belaya - MD, PhD.

Moscow,

Scopus Author ID 16506354000

jannabelaya@gmail.comhttps://orcid.org/0000-0001-7041-0732РожинскаяЛ. Я.RozhinskayaL. Ya.

Рожинская Людмила Яковлевна - д.м.н., профессор.

Москва

Scopus Author ID 55121221200

Liudmila Ya. Rozhinskaya - MD, PhD, Professor.

Moscow

Scopus Author ID 55121221200

lrozhinskaya@gmail.comГНЦ РФ ФГБУ «НМИЦ эндокринологии» Минздрава РоссииРоссияEndocrinology Research CentreRussian Federation2023170420242642025Copyright © Белая Ж.Е., Рожинская Л.Я., 20242024Белая Ж.Е., Рожинская Л.Я.Belaya Z.E., Rozhinskaya L.Y.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.osteo-endojournals.ru/jour/article/view/13166

Обзор литературы суммирует наши знания о применении суррогатных маркеров эффективности лечения остеопороза на фоне терапии бисфосфонатами (БФ). В качестве суррогатных критериев эффективности лечения остеопороза в рандомизированных контролируемых исследованиях использовались минеральная плотность кости (МПК) и маркеры костного ремоделирования, доказавшие свою связь с конечной клинической точкой — переломом. При назначении БФ для лечения остеопороза МПК, измеренная двухэнергетической рентгеновской остеоденситометрией (DXA), используется для мониторинга их эффективности не чаще 1 раза в 12 месяцев. Вместе с тем стабилизация МПК также является критерием эффективности лечения, так как изменения МПК определяют лишь 16% противопереломной эффективности БФ. Маркеры костного ремоделирования, в свою очередь, могут быть использованы уже через 3 (костной резорбции) или 6 (костеобразования) месяцев от начала терапии БФ, эффективным считается динамика снижения на 30% и более; существует прямая связь между степенью снижения маркеров костного ремоделирования и противопереломной эффективностью терапии БФ. Снижение маркеров сохраняется в течение всего периода терапии, и, соответственно, они могут быть использованы в качестве суррогатных маркеров эффективности и приверженности к терапии БФ в течение всего периода лечения. Вместе с тем наличие патологических переломов является ключевым клиническим проявлением остеопороза и, безусловно, имеет значительно больший вес при принятии решений по сравнению с любым суррогатным маркером.

Таким образом, при назначении терапии БФ для отслеживания эффективности лечения могут использоваться суррогатные маркеры изменения МПК и/или маркеров костного ремоделирования в течение всего периода лечения и наблюдения за пациентом.

A review of the literature which summarizes our knowledge on the use of surrogate markers of the osteoporosis treatment effectiveness when on bisphosphonate (BP) therapy. Bone mineral density (BMD) and markers of bone turnover, which have been shown to be associated with the clinical fracture end point, have been used as surrogate criteria for the effectiveness of treatment of osteoporosis in randomized controlled trials. When prescribing BP for the treatment of osteoporosis, BMD measurement every 12 months by dual-energy x-ray absorptiometry (DXA) is the well-described surrogate marker of BP efficacy. At the same time, stabilization of BMD is also a criterion for the treatment effectiveness since changes in BMD determined only 16% of the anti-fracture effectiveness of BP. Markers of bone remodeling can be used as surrogate markers after 3 (bone resorption) or 6 (bone formation) months from the start of BP therapy. A decrease of 30% or more is considered to be prognostically effective for both antifracture and BMD gain. There is a direct relationship between the degree of bone remodeling markers decrease and the antifracture effectiveness of BP therapy. The decrease in markers persists throughout the entire period of therapy and, accordingly, they can be used as surrogate markers of effectiveness and adherence to BP therapy throughout the entire treatment period. However, the presence of pathological fractures is a key clinical manifestation of osteoporosis and should be considered first in every decision making compared to any surrogate marker.

Thus, when prescribing BP treatment, surrogate markers of changes in BMD and/or markers of bone remodeling can be used to monitor the effectiveness of treatment throughout the entire period of treatment and patients’ monitoring.

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