Postmenopausal Osteoporosis Drug Shows Long-Term Safety

The researchers evaluated the incidences of adverse events seen in the initial study over 6 years of denosumab use
The researchers evaluated the incidences of adverse events seen in the initial study over 6 years of denosumab use

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 60mg 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 U.S. 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.

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