A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

Inclusion Criteria:

- Subject has provided informed consent/assent prior to initiation of any studyspecific
activities/procedures, or subject's legally acceptable representative has provided
informed consent prior to any study-specific activities/procedures being initiated
when the subject has any kind of condition that, in the opinion of the Investigator,
may compromise the ability of the subject to give written informed consent.

- Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or
spotting for 12 consecutive months prior to screening)

-≥ 55 to ≤ 90 years of age at the time of informed consent

- Ambulatory

- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by
the central imaging vendor at the time of screening, based on DXA scans -Subject has
at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the
principal investigator or designee

- Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator
or designee

- Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets
at least 2 of the following clinical risk factors for fracture

- ≥ 70 years of age at the time of informed consent

- BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed
by the central imaging vendor at the time of screening, based on DXA scans

- current smoker

- consumption of ≥ 3 glasses of alcohol a day

- parental history of fragility (ie, osteoporosis-related) fracture

- body weight ≤ 125 pounds/56 kilogram

- Ability to follow and understand instructions and the ability to self-inject, per
investigator judgement

Exclusion Criteria:

- History of ONJ and/or AFF

- History of metabolic or bone disease (except osteoporosis) that may interfere with the
interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid
arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing
spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome

- Subject 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)

- Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as
determined by the central laboratory. Vitamin D repletion will be permitted a nd
subjects may be rescreened

- Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by
subject report or by chart review, per principal investigator evaluation

- Current clinical hypothyroidism (unless well controlled on stable thyroid replacement
therapy) by subject report or by chart review, per principal investigator evaluation
normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined
as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent
hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in
normocalcemic subjects.

- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the
normal range, as assessed by the central laboratory. Serum calcium levels may be
retested once in case of an elevated serum calcium level within 1.1x the ULN as
assessed by the central laboratory