Tags

Type your tag names separated by a space and hit enter

Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease.
N Engl J Med. 2005 Sep 01; 353(9):898-908.NEJM

Abstract

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.

Authors+Show Affiliations

Department of Medicine, University of Auckland, Auckland, New Zealand. i.reid@auckland.ac.nzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16135834

Citation

Reid, Ian R., et al. "Comparison of a Single Infusion of Zoledronic Acid With Risedronate for Paget's Disease." The New England Journal of Medicine, vol. 353, no. 9, 2005, pp. 898-908.
Reid IR, Miller P, Lyles K, et al. Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. N Engl J Med. 2005;353(9):898-908.
Reid, I. R., Miller, P., Lyles, K., Fraser, W., Brown, J. P., Saidi, Y., Mesenbrink, P., Su, G., Pak, J., Zelenakas, K., Luchi, M., Richardson, P., & Hosking, D. (2005). Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. The New England Journal of Medicine, 353(9), 898-908.
Reid IR, 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. PubMed PMID: 16135834.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. AU - Reid,Ian R, AU - Miller,Paul, AU - Lyles,Kenneth, AU - Fraser,William, AU - Brown,Jacques P, AU - Saidi,Youssef, AU - Mesenbrink,Peter, AU - Su,Guoqin, AU - Pak,Judy, AU - Zelenakas,Ken, AU - Luchi,Monica, AU - Richardson,Peter, AU - Hosking,David, PY - 2005/9/2/pubmed PY - 2005/9/7/medline PY - 2005/9/2/entrez SP - 898 EP - 908 JF - The New England journal of medicine JO - N Engl J Med VL - 353 IS - 9 N2 - 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16135834/Comparison_of_a_single_infusion_of_zoledronic_acid_with_risedronate_for_Paget's_disease_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa044241?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -