PHILADELPHIA — Intermittent intravenous injections of ibandronate continue to improve bone mineral density of the spine and hip at 2 years, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.
Two-year results from the Dosing IntraVenous Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were superior to oral daily ibandronate (Boniva) in terms of increased bone mineral density (BMD) at the lumbar spine. The periodic IV injections were also superior to oral daily ibandronate at 1 and 2 years in terms of increased BMD for the total hip, trochanter, and femoral neck.
“IV ibandronate injections improve BMD at the spine and the hip [and] they produce superior BMD gains to oral dosing,” said Dr. E. Michael Lewiecki, osteoporosis director of the New Mexico Clinical Research and Osteoporosis Center and professor of medicine at the University of New Mexico in Albuquerque.
The study was funded in part by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. Dr. Lewiecki disclosed that he has received research grants from both.
DIVA was a randomized, double-blind, active-control study involving women aged 55–80 years, who were at least 5 years postmenopausal and who had a lumbar spine T score less than −2.5.
Overall 1,395 women were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women), 3 mg IV ibandronate every 3 months (472 women), or 2.5 mg daily oral ibandronate (469 women). All received daily calcium (500 mg) and vitamin D (400 IU) supplements.
The study's primary end point was mean percent change from baseline in lumbar spine BMD at 1 year, and these results were presented at the 2005 annual meeting of the American College of Rheumatology. Secondary end points included mean percent change from baseline in lumbar spine BMD at 2 years, and mean percent change from baseline in total hip, femoral neck, and trochanter BMD at 1 and 2 years.
In early 2006, the Food and Drug Administration approved the 3-mg trimonthly ibandronate IV injection for treating postmenopausal osteoporosis. “These data support the use of the every-3-month regimen in clinical practice,” Dr. Lewiecki said.
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