Long-Term Safety of Denosumab in Postmenopausal Osteoperosis

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Denosumab is approved to treat postmenopausal women with osteoporosis who are at increased fracture risk.
Denosumab is approved to treat postmenopausal women with osteoporosis who are at increased fracture risk.

According to a study published in the Journal of Bone and Mineral Research, there was no sign of increasing patterns regarding low-frequency or common adverse events with long-term use of denosumab for the treatment of postmenopausal osteoporosis.

Denosumab, an osteoclast inhibitor (RANKL inhibitor), is currently approved for the treatment of postmenopausal women with osteoporosis at increased or high risk for fracture, and other indications. 

The FREEDOM trial was 3-year fracture study that demonstrated denosumab 60 mg subcutaneously every 6 months significantly decreased new vertebral (68%), hip (40%), and nonvertebreal (20%) fractures. In addition, denosumab also increase bone mineral density (BMD) and lowered bone turnover markers when compared to placebo in postmenopausal women with osteoporosis.

However, there was an incidence of low-frequency adverse events seen in FREEDOM and the top 5 most common adverse events as listed in the US prescribing information (back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis).

Study authors evaluated the incidences of these adverse events in women who initially received placebo during the FREEDOM trial and then received denosumab for up to 3 years during the FREEDOM Extension trial ("crossover group"). Lead author Dr. Nelson B. Watts added, "This provided a unique opportunity for comparison with the original 3-year denosumab FREEDOM observations." 

They also evaluated the incidences of these adverse events over 6 years of denosumab use ("long-term group") and found no increasing trend with the imbalance of either low-frequency adverse events or common adverse events as seen in FREEDOM. "All of this is consistent with an excellent safety and tolerability profile for denosumab treatment for osteoporosis," stated Dr. Watts.

Reference

Watts NB, Brown JP, Papapoulos S, et al. Safety observations with 3 years of denosumab exposure: comparison between subjects who received denosumab during the randomized FREEDOM trial and subjects who crossed over to denosumab during the FREEDOM extension [published online April 3, 2017]. J Bone Miner Res. doi: 10.1002/jbmr.3119

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