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Monthly Ibandronate May Improve Patient Compliance With Osteoporosis Therapies: Presented at NAMS

By Cameron Johnston

WASHINGTON, DC -- October 13, 2004 -- A once-monthly formulation of bisphosphonate may go a long way toward improving patient compliance with this osteoporosis treatment while offering similar improving of bone mineral density (BMD).

In a series of poster presentations at the annual meeting of the North American Menopause Society, researchers discussed the preliminary outcomes of a long-term trial with once-monthly ibandronate. In the study, 1609 women received their normal daily dose of 2.5 mg or two doses of 50 mg each on consecutive days once a month, or once-monthly doses of either 100 mg or 150 mg.

The women's mean age was 65 to 66 years and their mean body mass index (BMI) was 26. The mean T-score at the lumbar spine was -3.3 in each of the study groups while mean T-score of the hip was -1.8.

The comparison point was to compare the efficacy of monthly dosing and normal daily dose.

In Poster 60, lead researcher Mark Ettinger, MD, rheumatologist from the Regional Osteoporosis Center of South Florida, Stuart, Florida, found no difference in bone alkaline phosphatase (BSAP), the marker for bone-formation, or in serum c-telopeptide (CTx), the marker for bone resorption, in patients taking ibandronate 100 mg or 150 mg per month compared with those taking the once-daily dose.

Changes from baseline for both markers BSAP and sCTx were observed within the first 3 months in all treatment arms and these changes carried out to 1 year. The only change that was greater than what was seen in the daily dose group was that of BSAP where the decrease was greater than in the daily-dose arm.

The reduction in bone resorption, as assessed by sCTx, was in the order of 70%, which is the amount required for osteoporosis treatments to be considered effective. The greatest changes were seen in patients taking the 150 mg once monthly dose.

In a second analysis (Poster 59) conducted by Ronald Emkey, MD, Head of Rheumatology, Reading Hospital and Medical Center, Reading, Pennsylvania, the same cohort experienced substantial increases in BMD at the lumbar spine. These improvements were seen in all treatment arms after 1 year of therapy. The changes ranged from approximately 3.75% in patients taking the standard daily dose up to 5% among patients taking the 150-mg/month dose.

Increases in hip BMD (both femoral neck and trocanter) favored patients in the 150 mg/month dose, but the difference in improvements seen in the trocanter were greater than what was seen at the femoral neck -- an improvement of approx 2 % versus 0.5%, respectively.

These data suggest that once-monthly dosing of ibandronate may be an effective alternative to once-daily bisphosphonate therapy, and could potentially address the poor compliance issues seen in postmenopausal osteoporosis, the researchers concluded.


[Presentation title: "Monthly Oral Ibandronate Effectively Reduces Bone Resorption in Women with Postmenopausal Osteoporosis (PMO): 1-Year Results from the MOBILE Study." Poster P60. "Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis (PMO): A Highly Effective Alternative to Daily and Weekly Bisphosphonates." Poster P59]

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