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Two-Year MOBILE Data Show Once-Monthly Oral Ibandronate to be Similar in Safety to Daily Formulation: Presented at NAMS

By Paula Moyer

SAN DIEGO, CA -- October 6, 2005 -- Women who have taken once-monthly oral ibandronate (Boniva) for up to 2 years tolerate treatment as well as do those on the once-daily regimen, investigators reported here on September 30^th at the 16^th annual meeting of the North American Menopause Society (NAMS).

The findings were part of the Monthly Oral iBandronate In LadiEs (MOBILE) study, a phase 3 non-inferiority study comparing different doses of once-monthly ibandronate to daily treatment with ibandronate. The 1-year MOBILE data was reported previously (ASBMR 26^th Annual Meeting: Abstract 408. 2004).

"These data were consistent with the 1-year MOBILE data," said Michael A. Bolognese, MD, Medical Director, Bethesda Health Research Center, Bethesda, Maryland, United States.

It is to be hoped that the convenience of the once-monthly dosing regimen, combined with the equivalent safety and tolerability, will "provide long-term adherence benefits to postmenopausal women with osteoporosis," Dr. Bolognese said.

The MOBILE researchers were interested in testing the monthly formulation because of the concern that postmenopausal women with osteoporosis often discontinue oral bisphosphonates due to adverse events. They wanted to see if less frequent dosing would reduce post-dose adverse events and therefore make treatment more tolerable. The researchers were particularly interested in oral ibandronate because, whether given daily or at a dosing interval of more than 2 months, was linked to a safety profile that was similar to placebo.

Their study compared safety and tolerability of 3 monthly ibandronate regimens with a daily regimen of 2.5 mg. The monthly doses were as follows: single doses of 50 mg on two consecutive days per month, one dose of 100 mg per month, and one dose of 150 mg per month.

Subjects were 1609 women, age 55 to 80 years, who had completed menopause for at least 5 years. They had confirmed osteoporosis, defined as a lumbar spine bone mineral density (BMD) T-score between -2.5 and -5. In addition to oral ibandronate, the women received daily supplemental calcium at 500 mg and daily supplemental vitamin D 400 IU.

The overall adverse event rate ranged from 65.5% in the 2.5 mg daily group to 80.3% in the group that received one single monthly dose of 100 mg. The most common adverse events were hypertension (11% to 14%); dyspepsia (8% to 10%); arthralgia (8% to 10%); back pain (8% to 10%); and nasopharyngitis (7% to 10%).

The rate of treatment-related adverse events ranged from 30.1% in the group receiving 50 mg on two consecutive days in each month to 36.9% in the group receiving one single monthly 100 mg dose. Typical treatment-related adverse events were those that affected the gastrointestinal tract, including dyspepsia, nausea, upper abdominal pain, vomiting, and gastroesophageal reflux disease.

After 2 years of therapy, the rate of treatment-related adverse events that led to withdrawal ranged from 5.1% in the group receiving two 50 mg doses per month to 7.6% in the group receiving 2.5 mg daily. Serious adverse events occurred at a rate of less than 1% in each treatment arm. Eight such events occurred, including 6 deaths. The other 2 serious events involved the upper gastrointestinal tract.

The participants had similar rates of upper gastrointestinal adverse events in all treatment groups.


[Presentation title: Safety Profile of Once-Monthly Oral Ibandronate: MOBILE 2-Year Results Abstract P-18]

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