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

A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China

The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.

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 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 chronic immunosuppression for any reason.
• Oral/dental conditions that would require an intervention including tooth extraction during the course of the study and invasive dental work (per local oral surgeon's assessment) planned in the next 12 months.
• Any prior use of products containing denosumab.
• Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Vitamin D levels < 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened).
• Albumin-adjusted serum calcium levels < 8.5 mg/dl or > 10.5 mg/dl.