Zusammenfassende Ergebnisse der ROSE-Studie

Zusammenfassung

Einleitung: In der hier beschriebenen ROSEStudie wurde die Behandlung mit Zoledronsäure 5 mg einmal pro Jahr mit der mit Alendronat 70 mg einmal wöchentlich im Hinblick auf den Knochenstoffwechsel und die Lebensqualität verglichen. Dieser Beitrag fasst die Ergebnisse zusammen, die in zwei separaten Manuskripten in Osteoporosis International veröffentlicht wurden.

Methoden: Die offene, nationale, multizentrische, randomisierte, kontrollierte Einjahresstudie untersuchte die Wirkung von Zoledronsäure und Alendronat auf Serum-NTx als primärem und Serum-P1NP als sekundärem Zielparameter. Studienziel war die Reduktion von NTx bzw. P1NP nach einem Jahr. An 95 deutschen Zentren wurden ca. 600 bisphoshonatnaive Frauen (Alter: 55 bis 90 Jahre, T-Score ≤−2,0 an Hüfte oder Wirbelsäule) im Verhältnis 2 : 1 randomisiert. Die Basismedikation bestand aus 1200 mg Kalzium und 800 IE Vitamin D pro Tag. Veränderungen von Lebens-qualität (QoL) und Schmerzintensität wurden mittels QUALEFFO-41 und VAS ermittelt.

Ergebnisse: Die Reduktion der NTx- und P1NP-Spiegel erfolgte in der Zoledronsäure- Gruppe schneller und stärker als in der Alendronat- Gruppe. Der Gesamt-Score QoL sowie die meisten Domänen des Qualeffo-41 tendierten zu einer größeren Verbesserung unter Zoledronsäure.

Schlussfolgerung: Die intensivere Knochendynamik unter Zoledronsäure stellt einen Vorteil für Patientinnen dar, bei denen ein schneller Wirkeintritt wichtig erscheint. Neben der Verbesserung der Gesamt-Lebensqualität hat die Infusion mit Zoledronsäure das Potenzial, die Compliance zu verbessern.

Summary

Background: The ROSE study investigated differences of a treatment with zoledronic acid 5 mg to alendronate 70 mg in postmenopausal women with osteoporosis or osteopenia with regard to the effect on bone metabolism and quality of life. This manuscript summarizes the study results that were recently published in two manuscripts in Osteoporosis International.

Methods: This 1-year, open label, multicenter, randomized, controlled trial in postmenopausal women investigated the effect of zoledronic acid and alendronate on serum NTx (primary objective) and serum P1NP (secondary objective). The main study parameter was the reduction of both bone markers after one year of treatment (assessed as area under the curve). Approximately 600 bisphosphonate-naive post - menopausal women (age: 55–90 years, T-Score ≤−2.0 at total hip or spine measured by DXA) were randomized at a ratio of 2 : 1 at 95 German study sites. All patients received daily doses of 1200 mg calcium and 800 I.U. vitamin D. Changes in health status, quality of life (QoL) and pain were assessed using Qualeffo- 41 questionnaires and VAS, respectively.

Results: Zoledronic acid showed a greater and more rapid reduction of serum NTx and P1NP compared to alendronate. At Month 12, improvement in health status was similar in both treatment groups. The QoL total score as well as most of the other domains showed tendency toward a larger improvement with zoledronic acid.

Summary: The stronger dynamic of bone markers suppression on a treatment with zoledronic acid represents an advantage for patients who require fast acting treatment. Zoledronic acid showed potential to improve quality of life as well as compliance.

Schlüsselwörter

ROSE-Studie - Zoledronsäure - Alendronat - Knochenstoffwechsel - Lebensqualität

Keywords

ROSE study - zoledronic acid - alendronate - bone metabolism - quality of life

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