Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Phase 3 Completed 1199 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

Timeline

Start: 2006-12
Primary completion: 2010-10
Completion: 2010-10

Outcome

Met primary endpoint

paper The rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period PMID 23113482 ↗

paper representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). PMID 23113482 ↗

Publications

Boonen S, Reginster JY, Kaufman JM, Lippuner K, Zanchetta J, Langdahl B, Rizzoli R, Lipschitz S, Dimai HP, Witvrouw R, Eriksen E, Brixen K, Russo L, Claessens F, Papanastasiou P, Antunez O, Su G, Bucci-Rechtweg C, Hruska J, Incera E, Vanderschueren D, Orwoll E. Fracture risk and zoledronic acid therapy in men with osteoporosis. N Engl J Med. 2012 Nov 1;367(18):1714-23. doi: 10.1056/NEJMoa1204061.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zoledronic acid	Other / unclassified	5 mg	Intravenous