In Brief: First Once-AMonth Osteoporosis Pill Approved


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First once-a-month osteoporosis pill approved


In spring 2005, the FDA approved the first drug for treating and preventing osteoporosis that can be taken in one monthly dose. The drug, ibandronate (Boniva), belongs to a class of antiresorptive agents called bisphosphonates, which increase bone density by slowing the rate of bone loss. Low bone density raises the risk of osteoporosis, a condition of bone fragility that affects more than eight million women in the United States. Denser bones mean less risk of fracture. Other oral bisphosphonates are risedronate (Actonel) and alendronate (Fosamax), available in once-weekly formulations.

A daily-dose version of Boniva was approved in 2003, but its makers, F. Hoffman-LaRoche and GlaxoSmithKline, delayed releasing it until they could offer a once-a-month version. Bisphosphonates are generally well tolerated, but they can irritate the esophagus and stomach, causing heartburn and nausea. Side effects may be less common with fewer doses, although remembering to take a drug at such widely spaced intervals may be a challenge.

To reduce the risk of side effects, take bisphosphonates first thing in the morning on an empty stomach with a full glass of water. Remain upright and avoid food, drink, and other medications for at least 30 minutes when taking a once-weekly dose of Actonel or Fosamax or the daily formulation of Boniva. For once-a-month Boniva, allow 60 minutes. People with severe kidney problems should not take Boniva.

Actonel and Fosamax have been shown to reduce the risk of spine, wrist, and hip fractures by 40%-50%. Daily Boniva reduces spinal fracture risk by 50% (more data are needed to evaluate its effect on other bones). The monthly version increases bone density at all bone sites, but no fracture data are available. All three drugs slow the rate of bone loss by limiting bone breakdown during normal bone remodeling. The only approved medication that actually builds new bone is teriparatide (Forteo), which is given as a daily injection only to patients who have a history of fractures or are at great risk for them.

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Last updated: August 21, 2006

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