Osteologie 2019; 28(01): 14-20
DOI: 10.1055/a-0800-0815
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Denosumab – die reversible Wirksamkeit im klinischen Fokus

Beobachtungen seit Registrierung bezüglich Wirksamkeit, Sicherheit sowie daraus abgeleitete Implikationen.Denosumab – the reversible efficacy in the clinical focusObservations since the registration regarding efficacy, safety, and derived implications.
Albrecht W. Popp
Universitätspoliklinik für Osteoporose, DOPH, Inselspital, Universitätsspital und Universität Bern
› Author Affiliations
Further Information

Publication History

11/07/2018

11/15/2018

Publication Date:
05 March 2019 (online)

Zusammenfassung

Seit der Registrierung von Denosumab 60 mg 6-monatlich subkutan zur Therapie der postmenopausalen Osteoporose konnte eine anhaltende Wirksamkeit über 10 Jahre gezeigt werden. Abgesehen von den eher seltenen unerwünschten Ereignissen, wie dem Auftreten von Osteonekrosen des Kiefers oder atypischen Femurschaftfrakturen, sind keine neuen Aspekte bei der Langzeitanwendung von Denosumab berichtet. Die Reversibilität nach dem Therapieabbruch von Denosumab führt zu einem rasch einsetzenden Knochenmineralverlust und kann in bestimmten Fällen mit dem erhöhten Risiko für multiple Wirbelkörperfrakturen assoziiert sein. Solange keine kontrollierten Studien vorliegen, welche die Wirksamkeit einer sicheren Strategie einer Anschlussbehandlung zur Kompensation des Rebound-Phänomens belegen, muss generell vom Therapieabbruch von Denosumab abgeraten werden. Teriparatid allein nach Stopp von Denosumab wird als kontraindiziert bezeichnet. Eine sequentielle, antiresorptive Anschlussbehandlung muss dem Einzelfall angepasst werden.

Abstract

Since registration of denosumab with a dose of 60 mg subcutaneously every 6 months for the treatment of postmenopausal osteoporosis a sustained efficacy over ten years has been demonstrated. Beyond the incidence of the rare adverse events, osteonecrosis of the jaw and atypical femoral fractures, no further safety concerns were reported during the long-term treatment with denosumab. The reversibility after discontinuation of denosumab leads to a rapid loss of bone mineral density and it is associated with an increased risk for multiple vertebral fractures in certain cases. As far as no controlled clinical data on the efficacy of a safe strategy of a follow-up therapy is available to compensate the rebound phenomenon, the discontinuation of denosumab can not be generally recommended. Teriparatide alone after denosumab has been deemed as contraindicated. A sequential antiresorptive follow-up therapy has to be adapted individually.

 
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