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Monthly ibandronate superior to daily dosing.(Clinical Rounds)

OB GYN News

| July 01, 2006 | Wendling, Patrice | COPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

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.

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