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Denosumab reduced wrist fracture in postmenopausal women with osteoporosis
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Upon further analysis of data from the FREEDOM trial, researchers confirmed that denosumab significantly improved radius bone mineral density, mass and strength compared with placebo, besides significantly reducing the risk for wrist fracture.
Researcher James A. Simon, MD, CCD, NCMP, FACOG, of George Washington University, and colleagues determined the effects of denosumab (Prolia, Xgeva; Amgen) on radius cortical and trabecular bone density, mass, strength and wrist fracture incidence from the study in which postmenopausal women with osteoporosis (n=7,808) received placebo or denosumab 60 mg every 6 months for 36 months.
James A. Simon
According to researchers, denosumab significantly increased areal BMD and volumetric BMD, bone mineral content and polar moment of inertia vs. placebo (all P<.05).
Data also indicate that wrist fracture incidence was 2.9% for placebo and 2.5% for denosumab with an RR reduction of 16% (P=.21) at 36 months. Moreover, patients with a femoral neck T-score of –2.5 or lower had an increased risk for wrist fracture. The researchers wrote that denosumab significantly reduced the incidence of wrist fracture (2.4%) compared with placebo (4%), with an RR reduction of 40% and an absolute risk reduction of 1.6% (P=.03).
According to the researchers, these findings confirm previously reported improvements to radius BMD after denosumab therapy in postmenopausal women with osteoporosis.
Disclosure: Several researchers report financial ties with Abbott, Agile Therapeutics, Amgen, Ascend Therapeutics, Azur Pharma, Bayer, BioSante Pharmaceuticals, Boehringer Ingelheim, Depomed, Eli Lilly, Endoceutics, Fabre-Kramer Pharmaceuticals, KV Pharmaceutical, Laboratoire HRA Pharma, Meditrina Pharmaceuticals, Merck, Merrion Pharmaceuticals, NDA Partners, Novartis, Novo Nordisk, Novogyne Pharmaceuticals, Nycomed, Pfizer, Polpharma, Roche, Sanofi-Aventis, Servier, Shionogi, Slate Pharmaceutical, Sprout Pharmaceuticals, Teva, Trovis Pharmaceuticals, United Osteoporosis Centers, Warner Chilcott, Watson Pharmaceuticals and Zentiva.
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