Yearly Zoledronic Acid Infusion Increases Lumbar Spine Bone Mineral Density Better Than Daily Oral Risedronate in Patients With Osteoporosis: Presented at ASBMR

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Title: Yearly Zoledronic Acid Infusion Increases Lumbar Spine Bone Mineral Density Better Than Daily Oral Risedronate in Patients With Osteoporosis: Presented at ASBMR
URL: http://www.pslgroup.com/dg/22C7E6.htm
Doctor's Guide
September 16, 2008

By Louise Gagnon

MONTREAL -- September 16, 2008 -- A once-yearly infusion of zoledronic acid improves lumbar-spine bone mineral density (BMD) compared with daily oral risedronate in specific subpopulations of patients with osteoporosis, according to research presented here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting.

At a poster session on September 15, Christian Roux, MD, PhD, Cochin Hospital and Descartes University, Paris, France, described the impact of IV administration of a bisphosphonate on patients with glucocorticoid-induced osteoporosis.

Dr. Roux, one of the investigators of the randomised, double-blind, double-dummy, stratified study, noted that osteoporosis associated with glucocorticoid therapy is being recognised as one of the most significant reasons for secondary osteoporosis.

The study enrolled 833 women and men 18 to 85 years old who were receiving oral prednisone and expected to continue that therapy for at least 12 months. Patients were divided into 2 populations at randomisation: a prevention population where patients were treated with glucocorticoids for up to 3 months (144 on zoledronic acid; 144 on risedronate) and a treatment population where patients received glucocorticoids more than 3 months (272 on zoledronic acid; 273 on risedronate).

The investigators examined the impact of other parameters such as age, mean prednisone dose during the trial, gender, and history of use of other medications on the outcomes with either daily oral risedronate 5 mg or a single infusion of zoledronic acid 5 mg and a daily oral placebo.

Results showed that men (P < .05) and women (P < .01) had gains in BMD at the lumbar spine in both the treatment and the prevention subpopulations. Additionally, in the treatment population, patients who were 35 to 64 years old achieved substantial gains in lumbar-spine BMD. And patients 65 to 74 years old in both the treatment and prevention subpopulations had significantly increased lumbar-spine BMD.

Patients with no history of use of proton-pump inhibitors, selective serotonin reuptake inhibitors, or antitumour necrosis factor therapies achieved statistically significant increases in lumbar-spine BMD, both in the treatment and the prevention subpopulations.

"There is higher bone mineral density in patients who received zoledronic acid compared to patients who received risedronate," said Dr. Roux.

"Zoledronic acid may give a better effect on bone mineral density than daily oral administration of a bisphosphonate," said Dr. Roux.

"Because persistence and compliance are so important for patients who get corticosteroid therapy, we think this method of infusion of bisphosphonates is a better way of administering bisphosphonates," Dr. Roux said

He noted, however, that despite the observed BMD increases in patients who received IV zoledronic acid, there was no observed impact on the fracture rate. "This is because we had very few fractures," he said.

Funding for this study was provided by Novartis Pharma AG.

[Presentation title: Effect of Zoledronic Acid (Single 5 mg Infusion) on Lumbar Spine Bone Mineral Density Versus Oral Risedronate (5 mg/day) Over 1 Year in Subgroups of Patients Receiving Glucocorticoid Therapy. Abstract 403]

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