Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China

Inclusion Criteria: * Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent. * Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture. * Have to have at least two intact vertebrae at baseline (L1-L4). Exclusion Criteria: * Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed). * Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed. * Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed). * Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol. * Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months. * Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization. * Oral bisphosphonates treatment. * Known to have tested positive …