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Prolia safe, effective in men with low BMD in phase 3 extension
Men with low bone mineral density had continued increases in mineral matter and maintained reductions in bone resorption with a second year of Prolia therapy, according to research published in the Journal of Clinical Endocrinology & Metabolism.
The extended treatment with Prolia (denosumab, Amgen) also increased BMD in men with osteoporosis and men with prostate cancer who were receiving androgen deprivation therapy, according to the researchers.
“One in four men in the U.S. over 50 years old will suffer an osteoporosis-related fracture,” the researchers wrote. “Less data are available on osteoporosis treatment in men than women.”
Bente L. Langdahl, MD, PhD, DMSc, of Aarhus University Hospital in Denmark, and colleagues from other institutions evaluated the drug for safety and efficacy in men aged 30 to 85 years in the multicenter, randomized phase 3 ADAMO trial in North America and Europe.
The second year of denosumab was a 12-month open-label phase that followed an initial 12-month double blind, placebo-controlled phase; 228 men entered the extension, and 219 completed it.
The researchers gave denosumab 60 mg subcutaneously to men from the original denosumab (long term) and placebo (crossover) groups every 6 months. The main outcomes measures sought were BMD, serum C-telopeptide and safety.
With long-term denosumab treatment, continued BMD increases occurred (2.2%, lumbar spine; 0.9%, total hip; 1.3%, femoral neck; 1.3%, trochanter; and 0.2%, 1/3 radius); from baseline, the cumulative 24-month gains were 8% for lumbar spine, 3.4% for total hip, 3.4% for femoral neck, 4.6% for trochanter and 0.7% for 1/3 radius (P < .01 for all).
The BMD gains observed in the crossover group after 12 months of denosumab therapy were similar to those in the long-term group in the first treatment year.
After denosumab administration, significant reductions in serum C-telopeptide were observed. Between long term and crossover, the adverse events rates were similar, and no new safety signals were identified.
“The continued increases in [BMD] through 2 years of treatment were comparable to those observed in previous studies of postmenopausal women with osteoporosis
(FREEDOM study), suggesting that denosumab is effective regardless of gender,” the researchers wrote. – by Allegra Tiver
Disclosure: The study was funded by Amgen. Langdahl reports financial relationships with Amgen, Axellus, Eli Lilly and Merck Sharp Dohme. Please see the full study for a list of all other authors’ relevant financial disclosures.