First IV Postmenopausal Osteoporosis Treatment Approved

MARCH 01, 2006
Susan Farley

The FDA recently approved Roche and GlaxoSmithKline's ibandronate sodium (Boniva) injection, making it the first intravenous treatment for postmenopausal osteoporosis. The approval was based on results from the DIVA study, a randomized, double-blind, multinational, noninferiority trial of 1358 women with postmenopausal osteoporosis. The participants received either the ibandronate sodium injection (3 mg every 3 months) or the once-daily oral formulation of ibandronate sodium. All participants were given calcium and vitamin D supplements throughout the trial. At the end of 1 year, lumbar spine bone mineral density (BMD) increased more in patients treated with ibandronate sodium injection than in those treated with ibandronate sodium tablets—4.5%, compared with 3.5%. Patients receiving the injections also had higher BMD increases at the hip, femoral neck, and trochanter than those taking the tablets. Investigators said that the injection "represents an important new opportunity to bring the bone-strengthening benefits of Boniva to more women—including those who have difficulty with dosing requirements of oral bisphosphonates."

Ms. Farley is a freelance medical writer based in Wakefield, RI.




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