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Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease.

Publication ,  Journal Article
Reid, IR; Miller, P; Lyles, K; Fraser, W; Brown, JP; Saidi, Y; Mesenbrink, P; Su, G; Pak, J; Zelenakas, K; Luchi, M; Richardson, P; Hosking, D
Published in: N Engl J Med
September 1, 2005

BACKGROUND: The advent of bisphosphonates advanced therapy for Paget's disease, but more effective and convenient agents are needed to increase adherence. Zoledronic acid, a bisphosphonate administered as a single intravenous infusion, might meet these needs. METHODS: In two identical, randomized, double-blind, actively controlled trials of 6 months' duration, we compared one 15-minute infusion of 5 mg of zoledronic acid with 60 days of oral risedronate (30 mg per day). The primary efficacy end point was the rate of therapeutic response at six months, defined as a normalization of alkaline phosphatase levels or a reduction of at least 75 percent in the total alkaline phosphatase excess. The results of the studies were pooled. RESULTS: At six months, 96.0 percent of patients receiving zoledronic acid had a therapeutic response (169 of 176), as compared with 74.3 percent of patients receiving risedronate (127 of 171, P<0.001). Alkaline phosphatase levels normalized in 88.6 percent of patients in the zoledronic acid group and 57.9 percent of patients in the risedronate group (P<0.001). Zoledronic acid was associated with a shorter median time to a first therapeutic response (64 vs. 89 days, P<0.001). Higher response rates in the zoledronic acid group were consistent across all demographic, disease-severity, and treatment-history subgroups and with changes in other bone-turnover markers. The physical-component summary score of the Medical Outcomes Study 36-item Short-Form General Health Survey, a measure of the quality of life, increased significantly from baseline at both three and six months in the zoledronic acid group and differed significantly from those in the risedronate group at three months. Pain scores improved in both groups. During post-trial follow-up (median, 190 days), 21 of 82 patients in the risedronate group had a loss of therapeutic response, as compared with 1 of 113 patients in the zoledronic acid group (P<0.001). CONCLUSIONS: A single infusion of zoledronic acid produces more rapid, more complete, and more sustained responses in Paget's disease than does daily treatment with risedronate.

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 1, 2005

Volume

353

Issue

9

Start / End Page

898 / 908

Location

United States

Related Subject Headings

  • Zoledronic Acid
  • Risedronic Acid
  • Quality of Life
  • Osteitis Deformans
  • Male
  • Infusions, Intravenous
  • Imidazoles
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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Reid, I. R., Miller, P., Lyles, K., Fraser, W., Brown, J. P., Saidi, Y., … Hosking, D. (2005). Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. N Engl J Med, 353(9), 898–908. https://doi.org/10.1056/NEJMoa044241
Reid, Ian R., Paul Miller, Kenneth Lyles, William Fraser, Jacques P. Brown, Youssef Saidi, Peter Mesenbrink, et al. “Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease.N Engl J Med 353, no. 9 (September 1, 2005): 898–908. https://doi.org/10.1056/NEJMoa044241.
Reid IR, Miller P, Lyles K, Fraser W, Brown JP, Saidi Y, et al. Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. N Engl J Med. 2005 Sep 1;353(9):898–908.
Reid, Ian R., et al. “Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease.N Engl J Med, vol. 353, no. 9, Sept. 2005, pp. 898–908. Pubmed, doi:10.1056/NEJMoa044241.
Reid IR, Miller P, Lyles K, Fraser W, Brown JP, Saidi Y, Mesenbrink P, Su G, Pak J, Zelenakas K, Luchi M, Richardson P, Hosking D. Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. N Engl J Med. 2005 Sep 1;353(9):898–908.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 1, 2005

Volume

353

Issue

9

Start / End Page

898 / 908

Location

United States

Related Subject Headings

  • Zoledronic Acid
  • Risedronic Acid
  • Quality of Life
  • Osteitis Deformans
  • Male
  • Infusions, Intravenous
  • Imidazoles
  • Humans
  • General & Internal Medicine
  • Female