Monthly Oral Ibandronate for Osteoporosis
Is Monthly Ibandronate Safe and Effective Long-term?
US researchers investigated the long-term safety and effectiveness of once-monthly ibandronate, which was studied for up to 5 years in a long-term extension (LTE) to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial.
The results of their study appeared online in September 2011(published in the journal Osteoporosis International) in the article “Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.”
The multi-center, double-blind extension study of monthly ibandronate included a total of 698 postmenopausal women. These women had completed 2 years of the MOBILE core study (with ≥75% adherence).
For the purposes of this study, patients were re-allocated or randomized from daily ibandronate to monthly ibandronate at 100 mg or 150 mg for an additional 3 years.
What Did Researchers Learn about Monthly Ibandronate for Osteoporosis?
The research team found that a pooled intent-to-treat (ITT) analysis of 344 patients who received monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine bone mineral density (BMD)—8.2% with 100 mg and 8.4% with 150 mg.
On average, 3-year data relative to MOBILE LTE baseline in the full ITT population of all 698 participants who were either re-allocated or randomized from the MOBILE trial (including the patients who were previously on daily ibandronate) showed preservation of proximal femur BMD gains achieved in the core 2-year study. In addition, small improvements were observed in lumbar spine BMD.
Maintenance of efficacy was indicated by markers of bone metabolism; and no tolerability concerns or new safety signals were noted.
At the end of the study, researchers determined that when taken long-term (up to 5 years), monthly ibandronate at 100 mg and 150 mg is both effective and well tolerated in postmenopausal women with osteoporosis.