Prolia® (denosumab) treatment for osteoporosis in men
was assessed in a study involving 242 men with osteoporosis. This study, entitled ‘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’ looked at men with low bone mass at risk of fracture.
Prolia® (denosumab) treatment for osteoporosis in men was also assessed in a study involving 1,468 men with non metastatic prostate cancer. This study, entitled ‘A Randomised, Double-blind, Placebo-controlled Study to Evaluate denosumab in the Treatment of Bone Loss in Subjects Undergoing Androgen-deprivation Therapy for Nonmetastatic Prostate Cancer’, looked at men with histologically confirmed prostate cancer and a history of osteoporotic fracture. The study included men with a bone density t score at the lumbar spine, total hip, or femoral neck of less than -1.0 or a history of an osteoporotic fracture.
The primary endpoint of the study at 24 months was the change in BMD of the lumbar spine .
Compared to placebo, denosumab significantly increased bone density at all
clinical sites measured.
All men received calcium (at least 1,000 mg) and vitamin D (at least 800 IU)
The study also looked at the number of patients who had spine fractures over three years. Prolia® demonstrated a significant relative risk reduction of new vertebral fractures at year 1, 2, and 3. In a prospectively planned exploratory analysis, significant increases in bone density were observed at the lumbar spine, total hip, femoral neck and the hip trochanter 1 month after the initial dose.