Reclast approved for biennial dosing regimen to prevent female osteoporosis

The FDA has approved Reclast (zoledronic acid, from Novartis) injection for the prevention of osteoporosis in women for two years with a single dose.  This approval was based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass. Reclast significantly increased lumbar spine BMD relative to placebo at the end of the two-year study.

Reclast is already approved for the treatment of postmenopausal osteoporosis; to reduce the incidence of new clinical fractures in patients at high risk of fractures; Paget’s disease of bone (men and women); and the treatment and prevention of glucocorticoid-induced osteoporosis in men and women expected to be on glucocorticoids for at least 12 months.

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