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Zoledronic acid

Classification: A

Drug products: Aclasta®, Zerlinda, Zoledronic Acid Accord, Zoledronic acid Actavis, Zoledronic Acid Fresenius Kabi, Zoledronic Acid Hospira, Zoledronic acid Mylan, Zoledronic Acid Teva, Zoledronsyra Hameln, Zoledronsyra medac, Zoledronsyra STADA, Zoledronsyra SUN, Zometa®

ATC code: M05BA08

Substances: zoledronic acid, zoledronic acid hemipentahydrate, zoledronic acid monohydrate, zoledronic acid trihydrate

Summary

Bisphosphonates increase the bone mineral density (BMD) as efficiently and give a comparable lower risk of fracture in men and women.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

The total body clearance of zoledronic acid is 5.04 ± 2.5 L/hour, independent of dose, and unaffected by sex, age, body weight and race. The clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested [1].

Effects

A post hoc analysis (265 men, 568 women) evaluated the effects of a single dose of IV zoledronic acid 5 mg versus oral risedronate 5 mg/day on lumbar spine BMD. Zoledronic acid treated patients had a higher increase in lumbar spine BMD in both men and women at month 12 compared to risedronate [2].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of zoledronic acid have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2014-08-06

References

  1. ZOMETA (zoledronic acid). Summary of Product Characteristics. European Medicines Agency (EMA); 2014.
  2. Roux C, Reid DM, Devogelaer JP, Saag K, Lau CS, Reginster JY et al. Post hoc analysis of a single IV infusion of zoledronic acid versus daily oral risedronate on lumbar spine bone mineral density in different subgroups with glucocorticoid-induced osteoporosis. Osteoporos Int. 2012;23:1083-90. PubMed
  3. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson