Rationale, baseline characteristics and methodology of the non-interventional VIVA^[*] study in postmenopausal osteoporosis

Summary

Background

It is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.

Methods

4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.

Results

At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).

Conclusion

The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

Zusammenfassung

Hintergrund

Es ist von großer Wichtigkeit, die Faktoren zu identifizieren, welche die Therapietreue in der Behandlung der postmenopausalen Osteoporose maßgeblich beeinflussen. Zielsetzung der vorliegenden VIVA-Studie, einer nichtinterventionellen Untersuchung, war es, die Therapietreue (Compliance und Persistenz) bei postmenopausalen Frauen mit Osteoporose, die auf eine einmal wöchentliche, orale Alendronat-Therapie oder eine i. v.- Ibandronat-Therapie gesetzt wurden, zu untersuchen.

Methoden

4477 Patienten, die Ibandronat 3 mg i. v. einmal im Quartal erhielten, und 1491 Patienten, die Alendronat 70 mg einmal pro Woche erhielten, wurden in die Studie eingeschlossen. Zusätzlich erfolgte eine Matched- Pair-Analyse von jeweils 901 Patientinnen aus beiden Gruppen. Das Matching erfolgte auf der Basis von Alter, Body-Mass-Index, prävalenten Frakturen bei Studieneinschluss, vorheriger Behandlung mit Bisphosphonaten sowie der Anzahl von Begleitmedikationen. Zu den sekundären Endpunkten zählten prävalente osteoporoseassoziierte Frakturen, Mobilität und Schmerzen, Analgetikaverbrauch, Lebensqualität sowie die Einstellung zur Medikation. Alle o. g. Faktoren warden im Rahmen der VIVA-Studien untersucht.

Ergebnis

Bei Studieneinschluss zeigte sich ein signifikanter Unterschied zwischen beiden Untersuchungsgruppen in Bezug auf das Körpergewicht, den Zeitpunkt der Osteo - porosediagnose und der Inzidenz prävalenter osteoporotischer Frakturen. Nach Einsetzen des Matched-Pair-Verfahrens zeigten sich nur noch Unterschiede in der Mobilität und der Lebensqualität.

Schlussfolgerung

In der Zusammenfassung der Ergebnisse der VIVA-Studie werden wichtige wissenschaftliche Erkenntnisse zur Therapietreue ermittelt, die gegebenenfalls in die Empfehlung für pharmakologische Behandlungen eingehen.

Keywords

Osteoporosis - fracture - compliance - ibandronate - alendronate

Schlüsselwörter

Osteoporose - Fraktur - Therapietreue - Ibandro - nat - Alendronat

^* VIVA = intravenous ibandronate versus oral alendronate

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