Introducere. Denosumab şi zolendronat sunt agenţi injectabili antiosteoporotici noi, care devin tot mai populari datorită regimului confortabil de administrare, totuşi, studii comparative ale eficacităţii acestora, deocamdată, lipsesc. Scopul lucrării. Determinarea eficacităţii a două intervenţii: denosumab vs. zolendronat în tratamentul pacientelor cu osteoporoză primară. Material şi metode. Studiu retrospectiv, de cohortă, 67 paciente (vârsta: 59,5 [47-72] ani). 32 paciente – terapie cu denosumab (60mg la fiecare ½ an) şi 35 – cu zolendronat (5mg anual), Clinica Medicală nr.5 a IMSP SCR (2013-2015). Parametrii eficacităţii: scorul-T şi markerii turn-overului osos la 6 şi 12 luni. Reacţiile adverse: evenimente flu-like, hepatobiliare, digestive, renale, cutanate şi hematologice. Statistica: t-Student, parametri descriptivi. Rezultate. Scorul-T, la 6 luni: denosumab + 16,4% vs. zolendronat 5,36%, p<0,05; la 12 luni: +31% vs.+28% p>0,05.Fosfataza acidă tartrat rezistentă, la 6 luni: denosumab – 45,5% vs. zolendronat – 23,68%, p<0,05; la 12 luni: -63,80% vs.-47,75%, p<0,05. Frecvenţa generală a reacţiilor adverse: denosumab 9,37% vs. zolendronat 31%, p<0,05, fenomene flu-like: denosumab 3,12% vs 31,42% zolendronat, p<0,05. Alte evenimente adverse: zolendronat – 1 caz ulcer duodenal, 1 caz hepatită medicamentoasă, 3 cazuri reacţii alergice, 1caz anemie uşoară, 2 cazuri leucopenie uşoară; denosumab – 1 caz herpes Zoster, 1 caz – hiper-ALAT-emie (x2ori). Concluzii. (1) Denosumab s-a prezentat a fi mai efectiv la 6 luni. (2) Ambele preparate au fost similare în eficienţă prin creşterea valorilor scorului-T cu 31% şi respectiv 28% la 12 luni. (3) Zolendronat – asociat cu o rată semnificativ mai mare de reacţii adverse vs. denosumab.

Introduction. Denosumab and zolendronate are new injectable antiosteoporotic drugs, which are increasing in popularity due to a convenient administration regimen, although there are no comparative trials of their efficacy. Objective of the study. To evaluate the efficacy of two interventions: denosumab and zolendronate in patients with primary osteoporosis. Material and methods. A retrospective, cohort study of 67 patients (age: 59.5 [47-72] years). 32 patients – denosumab therapy (60 mg once ½ year) and 35 – zolendronate (5 mg yearly), Medical Clinic No. 5, PMSI at Republican Clinical Hospital (2013-2015). The efficacy targets: T score and bone turn-over markers at 6 and 12 months. Adverse reactions: flu-like, hepatobiliary, digestive, renal, cutaneous and hemathologic events. Statistics: t-Student, descriptive parameters. Results. T-Score at 6 months: denosumab + 16.4% vs. zolendronate +5.36%, p<0.05; at 12 months: +31% vs.+28% p>0.05. Tartrate resistant acid phosphatase, at 6 months: denosumab – 45.5% vs. zolendronate – 23.68%, p<0.05; at 12 months: -63,80% vs.-47,75%, p<0.05. General frequency of adverse events: denosumab 9.37% vs. zolendronate 31%, p<0.05, flu-like events: denosumab 3.12% vs 31.42% zolendronate, p<0.05. Other adverse reactions: zolendronate – duodenal ulcer (1 case), drug-induced hepatitis (1 case), allergic reactions (3 cases), mild anemia (1 case), mild leocopenia (2 case); denosumab – herpes Zoster (1 case), 2-fold increase of ALAT (1 case). Conclusions. (1) Denosumab has shown a greater efficacy at 6 months. (2) At 12 months both drugs have shown similar efficacy by increasing the T- Score with 31% and 28%; (3) zolendronate has been associated with a higher rate of adverse events than denosumab.