Frakturen, Rückenschmerzen, Lebensqualität und Compliance unter einer Teriparatid-Therapie bei Patientinnen mit postmenopausaler Osteoporose in Deutschland

Zusammenfassung

Ziel: Primäres Ziel der Beobachtungsstudie EFOS war die Erfassung der Inzidenz von klinischen vertebralen und nichtvertebralen Frakturen bei postmenopausalen Frauen mit Osteo porose während einer 18-monatigen Teriparatid-Behandlung und einer 18-monatigen Nachbeobachtung. Weiterhin wurden gesundheitsbezogene Lebensqualität (EQ-5D und EQ-visuelle Analogskala [VAS]) und Rückenschmerzen (Häufigkeit, Schweregrad, Aktivitätseinschränkungen, VAS) evaluiert.

Methode: Veränderungen der Frakturinzidenz in jeweils 6-Monats-Intervallen wurden mittels logistischer Regression mit wiederholten Messungen und Veränderungen der VASWerte mit einem gemischten Modell für wiederholte Messungen analysiert.

Ergebnisse: Von 385 deutschen Patientinnen erlitten 44 (11,4 %) im Studienverlauf 52 Frakturen (17 vertebrale, 35 nicht-vertebrale). Die Inzidenz von Frakturen wurde signifikant reduziert (ab Monat 24 bis < 30 vs. Monat 0 bis < 6). Die sekundären Variablen verbesserten sich im Studienverlauf. Die Veränderungen waren dabei gegenüber dem Studienbeginn zu allen Zeitpunkten signifikant.

Schlussfolgerung: Die Befunde sind bei diesem nicht kontrollierten Studiendesign mit den entsprechenden Einschränkungen zu werten.

Summary

Aim: The primary objective of the European Forsteo Observational Study (EFOS) was to analyze the incidence of clinical vertebral and non-vertebral fractures in postmenopausal women with osteoporosis treated with teriparatide for up to 18 months. The active treatment period was followed by an 18-month follow-up period, where up to 44.2 % of patients received other osteoporosis medications. In addition to the incidence of fractures, health related quality of life (EQ-5D and EQ-visual analogue scale [VAS]), back pain (incidence and severity of back pain, activity limitations due to back pain, VAS) and bone mineral density (T-score) were evaluated.

Methods: Changes in the odds of fracture were analyzed in 6-month intervals using logistic regression with repeated measures and the changes in VAS scores were analyzed using a mixed model for repeated measures. Improvement/worsening from baseline in EQ-5D domains and in frequency and severity of patients with back pain were analyzed with the sign test. A total of 412 German patients participated in the EFOS study and 385 patients had evaluable data.

Results: The median duration of teriparatide treatment was 542 days (Q1 = 515 days, Q3 = 562 days). The most important reasons for discontinuing teriparatide were patient's decision and adverse events. A total of 44 patients (11.4 %) experienced 52 fractures (17 vertebral, 35 non-vertebral fractures) during Rückenthe study. The odds of fractures were significantly reduced (from months 24 to < 30 onwards versus months 0 to < 6; odds ratio interval 24 to < 30 months versus 0 to < 6 months: 0.20 [95 % confidence interval, CI 0.05, 0.85], p-value 0.029; odds ratio interval 30 to < 36 months versus 0 to < 6 months: 0.11 [95 % CI 0.01, 0.83], p-value 0.032). The frequency and severity of back pain was reduced and the health related quality of life improved in all 5 domains (change from baseline to all time points statistically significant, p < 0.001).

Conclusion: The results should be carefully interpreted in context of the observational study design.

Schlüsselwörter

Osteoporose - Teriparatid - Beobachtungs-studie - Subgruppenanalyse Deutschland

Keywords

Osteoporosis - teriparatide - observational study - subgroup analysis Germany

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