Monthly Oral Ibandronate Boosts Bone Mineral Density in the Lumbar Spine
Is monthly ibandronate safe and effective when taken long-term? That’s exactly what US researchers investigated in a recent study.
They looked at the overall 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.
Their findings were published online in late September 2011in an article called “Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.” It will soon be published in Osteoporosis International.
This multi-center, double-blind extension study involved 698 postmenopausal women who had completed 2 years of the MOBILE core study, with more than 75% adherence.
Study participants were either re-allocated or randomized from daily therapy to a monthly dose of 100 mg or 150 mg of ibandronate. Researchers followed these patients for 3 years.
The study found that over a span of 5 years, a pooled intent-to-treat (ITT) analysis of 344 patients who received a monthly dose of ibandronate from the core MOBILE baseline showed that lumbar spine bone mineral density (BMD) increased with monthly ibandronate (8.2% with 100 mg of monthly ibandronate and 8.4% with 150 mg of monthly ibandronate).
The 3-year data relative to MOBILE LTE baseline in the full ITT population of all 698 study participants who were re-allocated or randomized from MOBILE (including those patients who were previously on daily ibandronate) showed—on average—maintenance of proximal femur BMD gains achieved in the core 2-year study, with additional small gains in lumbar spine BMD. Maintenance of effectiveness was also observed by markers of bone metabolism.
In this study, it was noted that there were no tolerability concerns or new safety signals.
Researchers concluded that monthly treatment with ibandronate at either 100 mg or 150 mg is effective and well tolerated for up to 5 years in postmenopausal women who have osteoporosis.