Bioequivalence Study Comparing Romosozumab (AMG 785) Delivered Using a Prefilled Syringe Versus an Autoinjector

Subject has provided informed consent; Females must be of non-reproductive potential (ie, postmenopausal by history – no menses for 1 year – and follicle stimulating hormone (FSH) within or above the laboratory’s reference range consistent with postmenopausal status; OR history of hysterectomy; OR history of bilateral oophorectomy at least 6 weeks prior to screening), or history of bilateral tubal ligation; Body weight ≥ 45 and ≤ 95 kilograms at the time of screening.

History of osteoporosis, vertebral fracture, or fragility fracture [a fracture resulting from no or minor trauma (i.e., fall from standing height or less)] of the wrist, humerus, hip or pelvis after age 50; History of metabolic or bone disease such as sclerosteosis, Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome; Recent bone fracture within 6 months prior to screening; Vitamin D insufficiency, defined as 25-OH Vitamin D levels < 20 ng/mL; Evidence of current hyper- or hypoparathyroidism, renal disease: glomerular filtration rate (GFR) < 60 mL/min/1.73m², current hypocalcemia, history of hyper- or hypothyroidism, unless subject is on stable therapy > 6 months and has supporting laboratory documentation within 6 months prior to or at screening indicating normal serum thyroid-stimulating hormone [TSH] value; Subjects with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget’s disease, sclerosteosis and osteopetrosis); Positive for human immunodeficiency virus (HIV) at screening; Positive Hepatitis B Surface Antigen (HepBsAg) or detectable Hepatitis C virus; Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within 5 years prior to screening; History of solid organ or bone marrow transplants; Use of the following therapeutic agents affecting bone metabolism - intravenous bisphosphonates at any time in the past, fluoride (for osteoporosis) within 24 months prior to screening, denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822) within 18 months prior to screening, oral bisphosphonates, parathyroid hormone, or strontium within 12 months prior to screening, calcitonin, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams, which are acceptable) or tibolone within 3 months prior to screening, systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days) within 3 months prior to screening; Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), or receiving other investigational agent(s); Other investigational procedures while participating in this study are excluded; History of hypersensitivity or allergic reaction to mammalian cell derived drug products; Subject has previously entered this study or has previously participated in a study with a sclerostin antibody product; Females who are lactating/breastfeeding or have a positive pregnancy test at screening or day 1; Known alcohol abuse or use of illicit drugs within 12 months of randomization; Unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol is limited to no more than 2 units per day for the duration of the study; Positive urine screen for alcohol and/or potential drugs of abuse at screening or day 1, unless medication is prescribed by a physician and approved for use in study; Has donated or lost ≥ 400 mL of blood or plasma within 8 weeks prior to screening.