First IV Postmenopausal Osteoporosis Treatment Approved
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.