Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis

  • Authors: Ershova OB1, Lesniak OM2, Belova KI.1, Nazarova AV3, Manovitskaia AV4, Musaeva TM5, Mustaev RM6, Nurlygaianov RZ7, Rozhinskaia LI.8, Skripnikova IA9, Toroptsova NV10
  • Affiliations:
    1. ГБОУ ВПО "Ярославская государственная медицинская академия" Минздрава России
    2. ГБОУ ВПО "Северо-Западный государственный медицинский университет им. И.И, Мечникова" Минздрава России
    3. ГУЗ ЯО КБ СМП им. Н.В. Соловьева, Ярославль
    4. ФГБУ "ГНЦ Институт иммунологии" ФМБА России, Москва
    5. ООО "Преображенская клиника", Екатеринбург
    6. МБУ здравоохранения поликлиника №1, Уфа
    7. Городская клиническая больница №21, Уфа
    8. ФГБУ "Эндокринологический научный центр" Минздрава России
    9. ФГБУ "ГНИЦ профилактической медицины" Минздрава России
    10. ФГБУ "НИИ ревматологии им. В.А. Насоновой" РАН, Москва
  • Issue: Vol 86, No 10 (2014)
  • Pages: 60-64
  • Section: Editorial
  • URL: https://journals.rcsi.science/0040-3660/article/view/31587
  • ID: 31587

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Abstract

AIM. To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor κВ ligand (RANKL), within an open-label observational study. MATERIALS AND METHODS. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. RESULTS. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. CONCLUSION. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

About the authors

O B Ershova

ГБОУ ВПО "Ярославская государственная медицинская академия" Минздрава России

Email: yarosteoporosis@list.ru

O M Lesniak

ГБОУ ВПО "Северо-Западный государственный медицинский университет им. И.И, Мечникова" Минздрава России

K Iu Belova

ГБОУ ВПО "Ярославская государственная медицинская академия" Минздрава России

A V Nazarova

ГУЗ ЯО КБ СМП им. Н.В. Соловьева, Ярославль

A V Manovitskaia

ФГБУ "ГНЦ Институт иммунологии" ФМБА России, Москва

T M Musaeva

ООО "Преображенская клиника", Екатеринбург

R M Mustaev

МБУ здравоохранения поликлиника №1, Уфа

R Z Nurlygaianov

Городская клиническая больница №21, Уфа

L Ia Rozhinskaia

ФГБУ "Эндокринологический научный центр" Минздрава России

I A Skripnikova

ФГБУ "ГНИЦ профилактической медицины" Минздрава России

N V Toroptsova

ФГБУ "НИИ ревматологии им. В.А. Насоновой" РАН, Москва

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