Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

INCLUSION CRITERIA - ALL SUBJECTS :

- Males or females ≥ 50 years of age

- Body weight ≥ 45 and ≤ 110 kg

- Willing to adhere to calcium and vitamin D supplementation requirements

- Females must be of non-reproductive potential

INCLUSION CRITERIA - SUBJECTS WITH RENAL IMPAIRMENT (GROUPS 1 AND 2):

- Group 1 - Stage 4 RI (estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73
m²)

- Group 2 - End stage renal disease requiring hemodialysis

INCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3):

• Renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73
m²

EXCLUSION CRITERIA - ALL SUBJECTS:

- History of metabolic or bone disease (except for metabolic bone disease in renal
impairment (RI) subjects)

- History of osteoporosis, vertebral fracture, or fragility fracture of the wrist,
humerus, hip, or pelvis after age 50

- Recent bone fracture

- Vitamin D insufficiency

- Hypocalcemia or hypercalcemia

- Hypomagnesemia

- Hypophosphatemia

- Untreated hyper- or hypothyroidism

- Females with a positive pregnancy test

- Males with pregnant partners

- Females who are lactating/breastfeeding or plan to breastfeed on study and for 3
months after receiving the dose of study drug

- History of spinal stenosis

- History of facial nerve paralysis

- Positive for human immunodeficiency virus (HIV) antibodies

- Positive for hepatitis B surface antigen or detectable hepatitis C

- Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma,
cervical, or breast ductal carcinoma in situ) within 5 years before screening

- History of solid organ or bone marrow transplants EXCLUSION CRITERIA - HEALTHY
SUBJECTS (GROUP 3)

- Current hyper- or hypoparathyroidism