WASHINGTON — Postmenopausal women with osteoporosis who can't tolerate oral ibandronate may welcome an intravenous option, Michael Bolognese, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation.
One-year results from the Dosing Intravenous Administration (DIVA) study, an ongoing randomized, double-blind, phase III trial, showed that rapid injections of ibandronate (Boniva) in amounts of 2 mg every 2 months or 3 mg every 3 months were more effective than the standard oral daily dose of 2.5 mg at increasing bone mineral density (BMD), Dr. Bolognese of Bethesda (Md.) Health Research and his colleagues wrote in a poster presentation of their findings.
The increases in the BMD at the lumbar spine were significantly greater for women on both the 2-mg/2-mo (5.1%) and 3-mg/3-mo (4.8%) regimens compared with the 2.5-mg daily oral dosage (3.8%). In addition, significantly more patients demonstrated increased BMD from baseline in both the lumbar spine and total hip in the 2-mg/2-mo and 3-mg/3-mo groups compared with the daily oral 2.5-mg group.
The study included 1,395 women aged 55–80 years with postmenopausal osteoporosis. In addition to their ibandronate regimens, women in all treatment groups received 500 mg of calcium and 400 IU of vitamin D daily.
The incidence of renal adverse events such as urinary incontinence, renal impairment, or nephrolithiasis, was 3% or less across all treatment arms, and there were no significant changes in serum creatinine levels in any of the patients compared with baseline. The incidence of flu-like illness was low as well—3.3%, 3.2%, and 0.6% in the 2-mg/2-mo, 3-mg/3-mo, and 2.5-mg oral groups, respectively.
In addition, the overall incidence of clinical fractures, including vertebral fractures, was 3.1%, and did not differ significantly among the three groups, although it was slightly higher in the oral group (3.7%) compared with the 2-mg/2-mo group (2.9%) and the 3-mg/3-mo group (2.8%).
Dr. Bolognese is a consultant for Eli Lilly & Co. and Procter & Gamble Co., and has received grants or research support from Aventis Pharmaceuticals Inc., Pfizer Inc., Lilly, and Wyeth.