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IV treatment for postmenopausal osteoporosis approved
FDA ibandronate sodium injection is indicated for quarterly use.
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The FDA has approved an ibandronate sodium injection, the first IV medication for the treatment of postmenopausal osteoporosis, according to a recent announcement from Roche and GlaxoSmithKline.
The ibandronate sodium (Boniva) injection is the first quarterly medication for the treatment of postmenopausal osteoporosis.
“[The ibandronate sodium injection] is a truly novel osteoporosis therapy. It represents an important new opportunity to bring the bone-strengthening benefits of [the therapy] to more women – including those who have difficulty with dosing requirements of oral bisphosphonates,” said Robert R. Recker, MD, MACP, FACE, director, Creighton University Osteoporosis Research Center, Omaha, Neb., and an investigator in ibandronate sodium clinical trials.
The injection, administered as a 15- to 30-second IV injection, will provide an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 minutes to 60 minutes and/or swallow a pill.
Because the ibandronate sodium injection will be administered by health care professionals, clinicians will have a greater awareness of patient compliance with therapy.
Reduced fracture risk
Ibandronate sodium was first approved in a daily oral tablet formulation (2.5 mg) for the treatment and prevention of postmenopausal osteoporosis. Approval was based on studies showing that the therapy significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density in postmenopausal women without osteoporosis.
The injection (3 mg once every three months) was approved by the FDA based on results of the DIVA (Dosing IntraVenous Administration) study. DIVA was a randomized, double-blind, multinational, noninferiority trial in 1,358 women with postmenopausal osteoporosis who were treated with either an IV injection or the once-daily oral formulation of ibandronate sodium. All patients received supplemental calcium and vitamin D throughout the trial.
DIVA showed that the average increase in lumbar spine BMD at one year in patients treated with the ibandronate sodium injection was statistically superior to that in patients treated with the daily oral tablets (4.5% vs. 3.5% for the two treatments, respectively; P < 001).
The study also showed that patients treated with the ibandronate sodium injection had consistently higher BMD increases in the total hip and other skeletal sites (femoral neck and trochanter) than patients treated with oral daily ibandronate sodium.
In a one-year study comparing the injection to the 2.5-mg daily tablets, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were arthralgia, back pain, influenza, hypertension, abdominal pain, and nasopharyngitis.
In some patients, acute phase reaction-like events have been reported, usually only after the first injection. In most cases, no specific treatment was required and symptoms subsided in 24 to 48 hours.