BoneKEy Reports | BoneKEy Watch

Denosumab 5-year data in postmenopausal women with osteoporosis



DOI:10.1038/bonekey.2012.19

Denosumab inhibits RANKL and so reduces bone resorption by stimulating osteoclast activity. An extension of the 3-year FREEDOM trial has just reported 5-year data for 2443 women in the long-term group treated with denosumab for 5 years; 3 years in the treatment group of the original trial and 2 years in the extension. Results were compared with 2207 women in the original control group (the cross-over group) who began to receive denosumab at the end of year 3.

From year 3, bone turnover markers (BTMs) continued to reduce in the long-term group and fell rapidly in the cross-over group. After 5 years of treatment, BTMs were down by approximately 65% on baseline values, although the SD of the carboxy-terminal collagen crosslinks marker (CTX) was wider than for others.

Bone mineral density (BMD) in the lumbar spine and total hip increased in both groups following the same pattern. The annual rate of bone fracture in both groups was lower than in the control group of the original FREEDOM trial. No increase in adverse events, including infections, became apparent.

Editor's comment: Despite the absence of a control group during the extension, this study has some important findings: denosumab achieved stable inhibition of BTMs, a continuous gain of BMD at both spine and hip and a significant reduction in the incidence of non-vertebral fractures. A new method to build a twin–patient control group for years 4 and 5 is also presented.


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