The FDA has approved Roche and GlaxoSmithKline's ibandronate sodium injection (Boniva), the first intravenous (I.V.) medication for the treatment of postmenopausal osteoporosis. The product is also the first quarterly medication for the treatment of postmenopausal osteoporosis and is administered by a healthcare professional. Ibandronate sodium is already available in two oral formulations that can be taken once daily or once monthly.

Ibandronate sodium injection is administered as a 15- to 30-second I.V. injection and provides an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including the inability to sit upright for 30 to 60 minutes and/or swallowing a pill.

Ibandronate sodium injection was approved based on results of the DIVA study in over 1,300 women with postmenopausal osteoporosis who were treated with either an I.V. injection or the once-daily oral formulation of ibandronate. Results of the trial showed that the average increase in the lumbar spine bone mineral density (BMD) at 1 year in patients treated with I.V. ibandronate (3 mg once every 3 months) was statistically superior to that in patients treated with the daily oral tablets, as well as consistently higher BMD increases in the total hip and other skeletal sites.

The drug should not be given to patients with severe renal impairment. For more information, consult product labeling.