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Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams.

Publication ,  Journal Article
Reid, IR; Black, DM; Eastell, R; Bucci-Rechtweg, C; Su, G; Hue, TF; Mesenbrink, P; Lyles, KW; Boonen, S ...
Published in: J Clin Endocrinol Metab
February 2013

CONTEXT: Annual infusions of zoledronic acid 5 mg over 3 years have been shown to reduce fracture incidence. There is now evidence that the effects of a single dose of zoledronic acid on bone mineral density and bone turnover last for much more than a year. Whether this is associated with sustained fracture prevention is not known. OBJECTIVE: The objective of the study was to assess fracture incidence after only 1 infusion of zoledronic acid. DESIGN: The design of the study included post hoc analysis of subgroups of subjects from 2 trials, who received only 1 study infusion. SETTING: The study included multicenter, randomized controlled trials. PARTICIPANTS: A total of 1367 subjects from HORIZON-PFT and HORIZON-RFT studies who received only 1 of the planned annual infusions participated in the study. INTERVENTION: The intervention of the study consisted of 1 infusion of zoledronic acid or placebo. MAIN OUTCOME MEASURE: Clinical fracture was the main outcome measure of the study. RESULTS: Mean follow-up period was 1.5 years. In patients who received only a single infusion, there was a 32% reduction in clinical fracture comparing zoledronic acid with placebo over 3 years of follow-up (95% confidence interval 2-53%, P = .04), comparable with the fracture reduction seen in those who had 3 or more annual infusions (34%; 95% confidence interval, 23-43%, P < .0001). New morphometric vertebral fractures were reduced by 68% in the single-infusion group (P = .004). The between-group differences in total hip bone mineral density at 3 years were 3.8% in those receiving 1 infusion and 6.2% in those receiving 3 infusions. CONCLUSIONS: In this post hoc analysis based on postrandomization subgroups, fracture risk appears to be reduced for more than 1 year after a single infusion of zoledronic acid. Prospective studies designed to assess this possibility are now warranted.

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Published In

J Clin Endocrinol Metab

DOI

EISSN

1945-7197

Publication Date

February 2013

Volume

98

Issue

2

Start / End Page

557 / 563

Location

United States

Related Subject Headings

  • Zoledronic Acid
  • Treatment Outcome
  • Risk
  • Prospective Studies
  • Male
  • Incidence
  • Imidazoles
  • Humans
  • Fractures, Bone
  • Female
 

Citation

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Reid, I. R., Black, D. M., Eastell, R., Bucci-Rechtweg, C., Su, G., Hue, T. F., … HORIZON Pivotal Fracture Trial and HORIZON Recurrent Fracture Trial Steering Committees, . (2013). Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams. J Clin Endocrinol Metab, 98(2), 557–563. https://doi.org/10.1210/jc.2012-2868
Reid, I. R., D. M. Black, R. Eastell, C. Bucci-Rechtweg, G. Su, T. F. Hue, P. Mesenbrink, K. W. Lyles, S. Boonen, and S. HORIZON Pivotal Fracture Trial and HORIZON Recurrent Fracture Trial Steering Committees. “Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams.J Clin Endocrinol Metab 98, no. 2 (February 2013): 557–63. https://doi.org/10.1210/jc.2012-2868.
Reid IR, Black DM, Eastell R, Bucci-Rechtweg C, Su G, Hue TF, et al. Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams. J Clin Endocrinol Metab. 2013 Feb;98(2):557–63.
Reid, I. R., et al. “Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams.J Clin Endocrinol Metab, vol. 98, no. 2, Feb. 2013, pp. 557–63. Pubmed, doi:10.1210/jc.2012-2868.
Reid IR, Black DM, Eastell R, Bucci-Rechtweg C, Su G, Hue TF, Mesenbrink P, Lyles KW, Boonen S, HORIZON Pivotal Fracture Trial and HORIZON Recurrent Fracture Trial Steering Committees. Reduction in the risk of clinical fractures after a single dose of zoledronic Acid 5 milligrams. J Clin Endocrinol Metab. 2013 Feb;98(2):557–563.
Journal cover image

Published In

J Clin Endocrinol Metab

DOI

EISSN

1945-7197

Publication Date

February 2013

Volume

98

Issue

2

Start / End Page

557 / 563

Location

United States

Related Subject Headings

  • Zoledronic Acid
  • Treatment Outcome
  • Risk
  • Prospective Studies
  • Male
  • Incidence
  • Imidazoles
  • Humans
  • Fractures, Bone
  • Female