Artikel
The balto II study: preference for once-monthly oral ibandronate over weekly oral alendronate in postmenopausal women with osteoporosis
Patientenpräferenz für eine einmal monatliche Ibandronatbehandlung im Vergleich zu einer einmal wöchentlichen Alendronatbehandlung bei postmenopausalen Frauen mit Osteoporose
Suche in Medline nach
Autoren
-
P. Hadji
- Dept. of Gynecology, Gynecological Oncology & Endocrinology, University of Marburg, Marburg, Germany
-
T. Hennigs
- Frankfurt, Germany
-
H.-P. Kaps
- Braunfels, Germany
-
W. Kneer
- Stockach, Germany
-
A. Kurth
- Department of Orthopaedic Surgery, University Hospital Frankfurt, Frankfurt, Germany
-
H. Minne
- Klinik "Der Fürstenhof", Bad Pyrmont, Germany
-
H.-C. Schober
- Abt. für Innere Medizin, Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany
-
J. Semler
- Abt. für Stoffwechselerkrankungen mit Schwerpunkt Osteologie, Immanuel Krankenhaus, Berlin, Germany
| Veröffentlicht: | 28. September 2006 |
|---|
Gliederung
Text
Introduction: In women with postmenopausal osteoporosis (PMO), long-term non-adherence to therapy continues to be an important issue. The change from daily administration of bisphosphonates to weekly dosing has gone some way towards improving the problem, and it is possible that additional decreases in the frequency of dosing may provide further advantages. To assess the potential benefits of once-monthly administration of oral ibandronate compared with weekly alendronate dosing, two studies of identical design were initiated. Results from the BALTO I study (US) showed that patients had a strong preference for monthly ibandronate. Here we report results from the US/European study BALTO II.
Methods: BALTO II was a two-sequence, two-period, crossover, open-label study. In total, 350 women with PMO were enrolled into the study and randomized to one of two treatment sequences. Sequence A (n=176) consisted of three doses of monthly oral ibandronate (150mg), followed by 12 doses of weekly oral alendronate (70mg), while sequence B (n=174) consisted of the same treatments in reverse order. Patients’ attitudes to the two medications were assessed by questionnaire at the final study visit. Here we present results from the modified intent-to-treat (mITT) population, which consisted of 321 women who received at least one dose of each study medication and also completed the questionnaire at final visit.
Results: Of women in the mITT population, 93.1% (n=299) expressed a preference for one of the study agents. Of these women, significantly more stated that they preferred to receive monthly ibandronate (70.6%) compared with weekly alendronate (70.6% vs 29.4%; p<0.0001 for the monthly preference rate). When the participants’ reasons for preferring monthly ibandronate were assessed, 81.5% of women stated that it gave them the ability to facilitate long-term adherence, while 75.4% felt that it fitted better with their lifestyle. When questioned about the convenience of therapy, 85.0% of the women (n=273) expressed an opinion, with more preferring monthly ibandronate to weekly alendronate (76.6% vs 23.4%; p<0.0001 for the monthly convenience rate). Overall, the safety and tolerability of monthly ibandronate was similar to that of weekly alendronate.
Conclusions: In the BALTO II study, the majority of women preferred once-monthly administration of oral ibandronate to weekly dosing with oral alendronate, both for convenience and ease of use. These results are consistent with those of the identically designed US study (BALTO I), indicating that monthly dosing has the potential to further improve patient acceptability in postmenopausal osteoporosis.
