Approval of the new indication is based on results from the Phase 3 ADAMO trial (A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of DenosumAb 60 mg every six months versus placebo in Males with Osteoporosis), which evaluated a total of 242 men with low bone mineral density (BMD). Results showed that Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo (5.7% vs. 0.9%). Additional results showed that patients in the study who received Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip (2.4% vs. 0.3%) and at the femoral neck (2.1 % vs. 0%).
Prolia injection is a RANK ligand inhibitor, a regulator of osteoclasts. Prolia is already approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture. This is defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures. In addition, Prolia is indicated to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, to reduce incidence of vertebral fractures, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
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