The Medical Letter on Drugs and Therapeutics
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Denosumab (Prolia) for Postmenopausal Osteoporosis

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.

MECHANISM OF ACTION — Denosumab is a fully human anti-RANK ligand antibody that inhibits the proliferation, differentiation and maturation of preosteoclasts into active bone-resorbing cells. It decreases bone remodeling and increases bone mineral density.

PHARMACOLOGY — Following subcutaneous (SC) injection, serum concentrations of denosumab reach a maximum in 10 days and remain high enough to inhibit bone turnover for at least 6 months. By 9 months they fall below the effective range.

CLINICAL STUDIES — In a randomized, double-blind trial in 7808 women with postmenopausal osteoporosis, 60 mg of denosumab injected SC every 6 months for 3 years reduced the incidence of vertebral fracture compared to placebo from 7.2% to 2.3%, ... more      

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