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CHICAGO -- A 2-year analysis has shown that once-monthly ibandronate provides bone mineral density increases in women with postmenopausal osteoporosis superior to those seen with the proven daily dose.
Previously reported 1-year results from the Monthly Oral Ibandronate in Ladies (MOBILE) study showed that once-monthly ibandronate (Boniva) was superior to daily dosing at the spine and total hip, and comparable in other areas. "At 2 years there was actually superiority in all areas of the hip, plus the spine, and the adverse event profile was very comparable at 1 and 2 years," Dr. Michael A. Bolognese, who headed the prospective, phase III study for Hoffmann-La Roche Inc., said in an interview.
Overall, 1,609 women, aged 55-80 years, with postmenopausal osteoporosis were randomized to oral ibandronate 2.5 mg daily or to one of three different monthly ibandronate doses: 150-mg, 100-mg, or two 50-mg doses on 2 consecutive days. The per-protocol population included 395 women in the 2.5-mg daily group and 396 in the 150-mg monthly ibandronate group.
In a per-protocol analysis, mean lumbar spine bone mineral density scores increased 4% from baseline in the daily group and 5% in the monthly group after 1 year, and 5% and 7%, respectively, after 2 years.
Similar increases were seen in the intent-to-treat population, Dr. Bolognese and his associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.
After 2 years, superior mean bone mineral density gains were seen at the hip with 150-mg monthly ibandronate when it was compared with daily dosing (total hip, 4% vs. 3%; femoral neck, 3% vs. 2%; trochanter, 6% vs. 4%).
There was no difference in the incidence of clinical fractures between the daily- and monthly-dose groups (26 vs. 29). The number of withdrawals due to adverse events was low and comparable for daily and monthly treatment (10% vs. 9%), reported Dr. Bolognese, who is in private practice in Bethesda, Md., and is a Roche speaker and grant recipient.