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 theinformed consent.

• Men at the time of screening will be required to have lumbar spine or total hip BMDT-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 lowtestosterone 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 cancersare allowed).

• Any condition that in the opinion of the investigator would not allow the subject tocomplete 1 year study and comply with the requirement of the study protocol.

• Hypogonadism requiring testosterone replacement therapy unless on a stable dose forat least 12 months.

• Administration of intravenous bisphosphonate, or fluoride (except for dentaltreatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisoneequivalent per day for more than 14 days within 3 months before randomization. Anybone anabolic treatment within 1 year. Anabolic steroids or testosterone: any usewithin 6 months before randomization.

• Oral bisphosphonates treatment.

• Known to have tested positive for human immunodeficiency virus, hepatitis C virus,hepatitis B surface antigen, or cirrhosis of the liver.

• Received any solid organ or bone marrow transplant or is on chronicimmunosuppression for any reason.

• Oral/dental conditions that would require an intervention including tooth extractionduring the course of the study and invasive dental work (per local oral surgeon'sassessment) planned in the next 12 months.

• Any prior use of products containing denosumab.

• Currently receiving treatment in another investigational device or drug study, orless than 1 month since ending treatment on another investigational device or drugstudy(ies). Other investigational procedures while participating in this study areexcluded.

• Vitamin D levels < 20 ng/mL (subjects are allowed into the study after vitamin Dlevels are corrected and subjects re-screened).

• Albumin-adjusted serum calcium levels < 8.5 mg/dl or > 10.5 mg/dl.