my personal edition > orthopaedics other > news


  E-Mail this DGDispatch to a colleague

DGDispatch

High-dose Risedronate for Paget's Disease Not Damaging to Liver or Kidneys: Presented at ASBMR

By Bonnie Darves

SEATTLE, WA -- October 7, 2004 -- Use of risedronate in the treatment of Paget's disease appears to be safe with regard to kidney and liver effects, even at up to 6 times the dose typically prescribed for patients with osteoporosis.

The findings were presented October 6th at the American Society for Bone and Mineral Research's annual meeting.

The study of 275 men and women with Paget's disease with a mean age of 64, who had enrolled in several recent trials, found that even when risedronate was given in doses as high as 30 mg daily for up to 6 months, serum creatinine clearance remained at acceptable levels, said study co-author Simon Magowan, MD, of Procter & Gamble Pharmaceuticals, Mason, Ohio.

"This safety [profile finding] is reassuring news given the understandable concerns about using the drug at those high doses for a disease that's more prevalent in an age group where organ function also declines," he said.

When taken orally, risedronate is eliminated primarily through the kidneys, so its safety in larger doses is a concern to physicians who treat Paget's disease, Dr. Magowan said. "The attractive thing is that if you are going to have a liver or kidney problem show up [with treatment], you will get it fairly soon [after initiation of treatment] -- within a few weeks, one would expect -- with most of the dose-dependent reactions," he said.

After assigning a value of 1 to the patient whose serum risedronate concentration was lowest and had the best creatinine clearance, and determining a maximum ratio of 13.2, researchers tracked these values changes over the study period.

After 6 months of treatment, no statistically significant correlation was found between steady state serum concentrations of risedronate and serum creatinine levels (R2 =.02). This was the case also among patients with high baseline serum concentrations. "The correlation lines were basically 0% to 1%, which is no correlation whatsoever," Dr. Magowan said.

Renal function was similarly unaffected. Although, he noted that the patients in the study were slightly younger than those typically afflicted with Paget's, who are usually over 65 years. As such, liver and kidney function may need to be monitored closely in very elderly patients taking risedronate because of their expected poorer organ function.

He also acknowledged that because the study did not include a placebo group, the data are reflective of trends rather than an absolute effect of risedronate on renal or hepatic function.


[Presentation title: "Risedronate 30mg/day Exhibits Renal and Hepatic Safety Over Wide Range of Serum Steady State Concentrations. Abstract SU438]

E-Mail this DGDispatch to a colleague

To print, use this version