According to a study presented at the annual meeting of the Endocrine Society (Endo; 23–26 June, Houston, USA), denosumab (Prolia, Amgen) significantly increases bone mineral density at the lumbar spine and other skeletal points in men with low mineral density.
In the ADAMO (study to compare the efficacy and safety of denosumab versus placebo in males with osteoporosis) trial, 242 men were randomised (in a 1:1 fashion) to receive 60mg denosumab or placebo intravenously once every six months over a 12-month period. Men were eligible for inclusion in the study if they aged between ≥30 and ≤85 years, had a T-score of ≤-2 and ≥-3.5 at the lumbar spine or femoral neck, or had a prior major osteoporotic fracture and a T-score of ≤1 and ≥-3.5 at the lumbar spine or femoral neck. The primary endpoint was to evaluate the change in lumbar spine BMD from baseline to 12 months.
Ugis Gruntmanis, chief, Division of Endocrinology, Dallas Veterans Affairs Medical Center and University of Texas Southwestern Medical Center, Dallas, USA, and others reported: “After 12 months of treatment with denosumab, bone mineral density increased from baseline by 5.7%, 2.4%, 2.1%, 3.1%, and 0.6% at lumbar spine, total hip, femoral neck, trochanter, and forearm, respectively (all p<0.01 compared with placebo).” They added that the treatment was associated with an increase in lumbar spine BMD in all subgroups (patients were grouped by testosterone levels, minimum BMD T-scores, and 10-year major osteoporosis fracture risk). According to Gruntmanis et al, this indicates that denosumab is “effective across different clinical situations.”
Gruntmanis told Spinal News International: “As many people know, and what bothers me the most, 30% of hip fractures, 20% of forearm fractures, 42% of clinical vertebral fractures, and 25% of humerus fractures are occurring in men—or, in other words, there are nearly 3.5 million fractures in men a year around the world. Furthermore, the one-year mortality after a hip fracture is nearly two times higher for men than for women and yet just an absolute minority of men ever gets treated or diagnosed with osteoporosis even after fracture takes place—it is hard to believe! Denosumab, clearly, will add to armamentarium we have available in treatment for male osteoporosis, and because subcutaneous injections need to be used every six month, compliance may likely improve and that is very important in treating any chronic condition.
At present, densoumab is FDA approved for increasing bone mass in men who are at high risk of fracture after receiving androgen deprivation therapy for non-metastatic prostate cancer.