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Intermittent dosing of ibandronate effective
Good safety profile, longer between-dose intervals may improve patient adherence to therapy.
Minneapolis — Oral daily and intermittent ibandronate are well tolerated in postmenopausal women with osteoporosis, regardless of age, according to analysis of a large-scale, randomized, placebo-controlled, fracture prevention study.
Mark Ettinger, MD, of Radiant Research and emeritus medical director of the Regional Osteoporosis Center of South Florida in Stuart, noted that elderly women with osteoporosis may be more vulnerable to drug-related adverse events than younger women due to their decline in functional status and the presence of comorbidities.
In an interview at the 25th Annual Meeting of the American Society for Bone and Mineral Research, Ettinger said that postapproval experience with other daily bisphosphonates has led to concern over adverse effects in older patients, especially gastrointestinal (GI) side effects. Patients with osteoporosis may be frail and may be receiving multiple medications, increasing their vulnerability to medication side effects.
Study assessed safety
This analysis of the BONE (Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe) study assessed two bisphosphonate dosing regimens with respect to safety differences among the patient groups older than 70 (mean age 74) and younger than 70 (mean age 63.8). The study design addressed GI toxicity concerns.
“In this study, patients with pre-existing GI disorders were specifically not excluded, even if they were taking H2 blockers or proton pump inhibitors at baseline,” Ettinger said. This “proof of concept” study tested both daily oral dosing and also whether or not larger doses could be given with long periods of time between dosing intervals (±66 days with no dosing each cycle) thereby easing the inconvenience of daily or once-weekly dosing.
The BONE study enrolled 2946 women aged 55 to 80 years and five years or more postmenopause, randomizing them to three groups: 2.5 mg of oral daily ibandronate, 20 mg of oral ibandronate every other day totaling 12 doses every three months, or oral daily placebo. All patients received 500 mg of calcium and 400 IUs of vitamin D supplementation daily.
The multinational study examined the efficacy and safety of ibandronate over three years. Previously reported efficacy findings showed new vertebral fracture rates reduced by 62% for daily dosing (P=.0001 vs. placebo) and by 50% for intermittent dosing (P=.0006) after three years.
Ettinger reported that about 30% of patients had histories of GI disorders, and that the most commonly administered concomitant medications were for digestive disorders: antacids/antiflatulents (61% to 63%) and ulcer-healing drugs (eg, proton-pump inhibitors/H2 –receptor antagonists, 13% to 15%). Proportions of women older than 70 were similar in the three treatment groups (about 48%). All had one to four prevalent vertebral fractures (T4-L4) and BMD T-scores of –2.0 to –5.0 in one or more vertebra (L1-L4). About 43% of women had two fractures.
Drug-related adverse events were similar between groups, with few leading to withdrawal from study treatment. There were no increases in upper digestive system adverse events.
Ettinger said that age did not affect tolerability. “Despite the 30% with GI disorder histories, there was no increase in GI or any other disorders.”
For more information:
- Ettinger M, Skag A, Hoiseth A, et al. Oral daily and intermittent ibandronate have a similar safety profile in elderly and younger patients: results from the BONE study. #SA343. Presented at the 25th Annual Meeting of the American Society for Bone and Mineral Research. Sept. 18-23, 2003. Minneapolis.