FDA approved zoledronic acid injection to treat postmenopausal osteoporosis

The FDA approved zoledronic acid injection as the first therapy to treat postmenopausal osteoporosis for two years with a single dose.

Zoledronic acid injection was previously approved as a once-yearly infusion to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, to treat and prevent osteoporosis caused by glucocorticoids and for the treatment of Paget’s disease of bone.

The active ingredient is zoledronic acid 5 mg administered once a year (Reclast, Novartis) when treating postmenopausal osteoporosis.

Approval was based on results of a two-year, randomized, multicenter, double-blind, placebo controlled trial of 581 postmenopausal women. In that trial, a single infusion of zoledronic acid significantly increased BMD at two years compared with placebo.

Patients were divided into three groups and assigned to receive either zoledronic acid injection at the beginning of the study and again at one year; zoledronic acid injection at the beginning of the study and placebo at one year; or placebo at the beginning of the study and again at one year.

Zoledronic acid injection significantly increased lumbar spine BMD relative to placebo at the end of the study period. Treatment with zoledronic acid injection given as a single dose at the beginning of the study increased lumbar spine BMD by 6.3% in the early menopause group and by 5.4% in the late menopause group (P<.0001).

The most common adverse events associated with zoledronic acid are flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting and diarrhea.

For more information, visit the Reclast or FDA websites.