FDA approves intravenous treatment for bone health

Washington -- An intravenous treatment for osteoporosis was approved Jan. 6 by the Food and Drug Administration. Injections with Boniva, or ibandronate sodium, would be administered once every three months by a physician.

The new treatment was welcomed by Felicia Cosman, MD, clinical director of the National Osteoporosis Foundation, as a long-awaited alternative for those who can't take the oral medications that have been available for several years.

The tablets have presented a problem for some elderly people who have difficulty swallowing, Dr. Cosman said. Plus, the pills require an individual to remain upright for one-half hour to an hour after taking them and before eating or drinking anything other than water, a complex regimen for some, and one that has led to a poor adherence rate.

Osteoporosis affects about 10 million people in the United States with the majority being women, particularly postmenopausal women. As the population ages, the likelihood is that many more women will be threatened with the condition.

Poor bone health is implicated in 1.5 million fractures each year in the United States among both men and women, according to a recent U.S surgeon general report. And fractures, particularly hip fractures, can start an individual down a path toward disability and even an early death.

Bisphosphonates and selective estrogen receptor modulators, which act as antiresorptive agents to reduce bone loss, and anabolic agents that build bones have provided physicians with powerful tools to prevent and treat bone loss.

A recent study suggested that taking bisphosphonates and parathyroid hormone, both effective bone medications, in sequence could prove a more effective way to strengthen bone.

Estrogen therapy, another effective treatment, fell from favor when the Women's Health Initiative study found that the hormone had caused an increase in breast cancer.

Last spring, the FDA approved a once-monthly tablet of Boniva, which broadened the range of dosing options beyond the already available once-daily and once-weekly schedules of several medications.

Injectable Boniva's approval was based on a one-year randomized trial that compared the injection with Boniva's 2.5 mg daily tablet among 1,358 postmenopausal women. The most common adverse effects reported were joint and back pain. The injectable dose is 3 mg/3 mL.

The drug is expected to become available early this year.