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Prolia and Reclast effectiveness and side effects compared in small study

(RxWiki News) Women with osteoporosis (brittle bones) have two effective treatment choices: Prolia (denosumab) and Reclast (zoledronic acid). So which is more effective? A recent study did a side-by-side comparison.

This study's investigators found that Prolia increased spine bone mineral density more than Reclast. Women taking Reclast had flu-like symptoms, while those taking Prolia experienced none.

Women were equally satisfied with their treatment, regardless of the medication they took.

"Discuss osteoporosis treatment options with your doctor."

Three researchers conducted this study designed to look at the efficacy and side effects of both medications. Kellen Sheedy, a student at the Loyola University Stritch School of Medicine, was the first author.

Prolia was approved by the US Food and Drug Administration (FDA) in 2010 to treat osteoporosis in postmenopausal women. The medication, which blocks bone loss and fracture risks, is given by injection every six months.

The FDA approved Reclast in 2007 to treat osteoporosis. It also inhibits the process by which bones breakdown. This medication is given intravenously (in the vein) every 12 months.

The standard test for measuring bone health — dual-energy x-ray absorptiometry, or DXA — was used to measure bone mineral density. The DXA results were compared to the peak bone mineral density of a 30-year-old adult to calculate what’s called a “T-Score’.

Sheedy’s team in this study reviewed the charts of 107 women, 51 of whom took Prolia and 56 of whom received Reclast.

These researchers discovered that women in the Prolia group had a greater average increase in spine bone mineral density (0.060 g/cm2) than did women taking Reclast, who saw a 0.021 g/cm2 increase.

There were no significant differences between the two groups in terms of other bone health measurements, including changes in femur (thigh bone) T-scores and bone mineral density and changes in spine T-scores after one year of therapy.

Nearly one-third (29 percent) of the women taking Reclast experienced mild flu-like symptoms after taking the medication, whereas none of the participants taking Prolia had these symptoms.

A subgroup of 29 study participants completed a survey regarding how well they tolerated the medications, cost and overall satisfaction with the treatment they received.

Both groups were satisfied with their treatment. Reclast treatment was covered by all insurance companies, and only two of the women said they had co-payments ($150 and $1,500). Three participants had co-pays, ranging from $70 to $1,800, for the two Prolia treatments, which were covered by 93 percent of insurers.

Study co-author Pauline Camacho, MD, director of the Osteoporosis & Metabolic Bone Disease Center at Loyola University Health System, said in a statement, "This study helped us quantify the efficacy and adverse effects of these two drugs providing further guidance for physicians who prescribe these treatments.” She added that additional larger studies are needed to confirm these results.

The price for a 100-ml injection of 5 mg/100 ml of Reclast is about $1,150, and five syringes of 1-ml of Prolia at 60 mg/ml cost roughly $4,500.

Findings from this study were presented at the 2013 annual meeting of American Society for Bone and Mineral Research. All research is considered preliminary before publication in a peer-reviewed journal.

Review Date: 
December 4, 2013