First IV Postmenopausal Osteoporosis Treatment Approved

Pharmacy Times, Volume 0, 0

The FDA recently approved Roche andGlaxoSmithKline's ibandronate sodium(Boniva) injection, making it the first intravenoustreatment for postmenopausalosteoporosis. The approval was based onresults from the DIVA study, a randomized,double-blind, multinational, noninferioritytrial of 1358 women with postmenopausalosteoporosis. The participantsreceived either the ibandronatesodium injection (3 mg every 3 months)or the once-daily oral formulation of ibandronatesodium. All participants weregiven calcium and vitamin D supplementsthroughout the trial. At the end of1 year, lumbar spine bone mineral density(BMD) increased more in patientstreated with ibandronate sodium injectionthan in those treated with ibandronatesodium tablets—4.5%, comparedwith 3.5%. Patients receiving theinjections also had higher BMD increasesat the hip, femoral neck, and trochanterthan those taking the tablets. Investigatorssaid that the injection "representsan important new opportunity tobring the bone-strengthening benefits ofBoniva to more women—including thosewho have difficulty with dosing requirementsof oral bisphosphonates."

Ms. Farley is a freelance medicalwriter based in Wakefield, RI.